Statistiche di base
LEI | 549300EOES47LATSET33 |
CIK | 1590877 |
SEC Filings
SEC Filings (Chronological Order)
August 18, 2025 |
REGENXBIO Announces FDA Review Extension of BLA for RGX-121 to Treat Patients with MPS II EXHIBIT 99.1 REGENXBIO Announces FDA Review Extension of BLA for RGX-121 to Treat Patients with MPS II - RGX-121 would be the first and only potential one-time commercially-available therapy designed to directly address the underlying genetic cause of Hunter syndrome, if approved - Commercial launch plans remain on track - REGENXBIO plans to present updated pivotal data during the ICIEM meeting in |
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August 18, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 18, 2025 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Num |
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August 7, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 05, 2025 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Num |
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August 7, 2025 |
REGENXBIO Reports Second Quarter 2025 Financial Results and Operational Highlights EXHIBIT 99.1 REGENXBIO Reports Second Quarter 2025 Financial Results and Operational Highlights • RGX-202 in Duchenne muscular dystrophy on track for topline results 1H 2026 and BLA submission mid-2026 o Pivotal trial enrollment accelerated, expected to complete in October 2025 ahead of previous guidance • Clemidsogene lanparvovec (RGX-121) on track to be first gene therapy and one-time treatment |
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August 7, 2025 |
EXHIBIT 10.4 Execution Version Certain identified information has been excluded from this exhibit because such information both (i) is not material and (ii) would likely cause competitive harm if publicly disclosed. Excluded information is indicated with brackets and asterisks. LOAN AGREEMENT Dated as of May 16, 2025 Between REGENXBIO RS LLC, as Borrower, and HCR RGNX ROYALTY SPV, LP, as Lender TA |
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August 7, 2025 |
Form of Restricted Stock Unit Award Agreement for the 2025 Equity Incentive Plan EXHIBIT 10.2 REGENXBIO INC. 2025 EQUITY INCENTIVE PLAN NOTICE OF RESTRICTED STOCK UNIT AWARD REGENXBIO Inc. (the “Company”) has granted you (the “Grantee”) Stock Units (this “Award”) with respect to shares of the common stock of the Company on the following terms: Name of Grantee: [Participant Name] Total Number of Stock Units Granted: [Number of Stock Units] Date of Grant: [Grant Date] Vesting Sc |
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August 7, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001 |
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August 7, 2025 |
Form of Stock Option Award Agreement for the 2025 Equity Incentive Plan EXHIBIT 10.3 REGENXBIO INC. 2025 EQUITY INCENTIVE PLAN NOTICE OF STOCK OPTION GRANT REGENXBIO Inc. (the “Company”) has granted you (the “Optionee”) the following option (the “Option”) to purchase shares of the common stock of the Company: Name of Optionee: [Participant Name] Total Number of Common Shares: [Number of Options] Type of Option: [ISO or NSO] Exercise Price per Common Share: [Exercise P |
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August 7, 2025 |
REGENXBIO Announces Pivotal Program for Surabgene Lomparvovec in Diabetic Retinopathy EXHIBIT 99.2 REGENXBIO Announces Pivotal Program for Surabgene Lomparvovec in Diabetic Retinopathy - A pivotal Phase IIb/III clinical trial using suprachoroidal delivery for treatment of diabetic retinopathy will be initiated - New Phase II ALTITUDE® trial data demonstrate a durable safety and efficacy profile observed through two years with a single, in-office injection of surabgene lomparvovec i |
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June 25, 2025 |
Up to 268,096 Shares of Common Stock Table of Contents Filed Pursuant to Rule 424(b)(3) Registration No. 333-288053 PROSPECTUS Up to 268,096 Shares of Common Stock This prospectus relates to the resale of up to 268,096 shares of common stock, par value $0.0001 per share (the “Shares”), of REGENXBIO Inc. (the “Company,” “we,” “our” or “us”) by the selling stockholder named in this prospectus (the “Selling Stockholder”). The Shares are |
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June 23, 2025 |
CORRESP June 23, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Doris Stacey Gama Re: REGENXBIO Inc. (the “Company”) Registration Statement Filed on Form S-3 (the “Registration Statement”) File No. 333-288053 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, the Compan |
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June 13, 2025 |
EX-FILING FEES Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) REGENXBIO Inc. |
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June 13, 2025 |
EX-4.5 Exhibit 4.5 REGENXBIO INC. WARRANT TO PURCHASE COMMON STOCK Number of Warrant Shares: 268,096 (subject to adjustment) Warrant No. 1 Original Issue Date: May 16, 2025 REGENXBIO Inc., a Delaware corporation (the “Company”), hereby certifies that, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, HCR RGNX ROYALTY SPV, LP. or its permitted regist |
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June 13, 2025 |
As filed with the Securities and Exchange Commission on June 13, 2025 As filed with the Securities and Exchange Commission on June 13, 2025 Registration No. |
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June 13, 2025 |
EXHIBIT 107 Calculation of Filing Fee Tables Form S-8 (Form Type) REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1)(2) Proposed Maximum Offering Price Per Unit(3) Maximum Aggregate Offering Price(3) Fee Rate Amount of Registration Fee Equity Common Stock, par value |
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June 13, 2025 |
REGENXBIO Inc. 2025 Equity Incentive Plan EXHIBIT 99.1 REGENXBIO INC. 2025 EQUITY INCENTIVE PLAN ARTICLE 1. INTRODUCTION. 1.1 Purpose. The purpose of the Plan is to promote the long-term success of the Company and the creation of stockholder value by (a) encouraging Service Providers to focus on critical long-range corporate objectives, (b) encouraging the attraction and retention of Service Providers with exceptional qualifications and ( |
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June 13, 2025 |
As filed with the Securities and Exchange Commission on June 13, 2025 S-3 Table of Contents As filed with the Securities and Exchange Commission on June 13, 2025 Registration No. |
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June 3, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 30, 2025 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Number |
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May 19, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 16, 2025 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Number |
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May 19, 2025 |
REGENXBIO Announces Strategic Royalty Monetization Agreement for Up to $250 Million EXHIBIT 99.1 REGENXBIO Announces Strategic Royalty Monetization Agreement for Up to $250 Million • $150 million secured at closing extends cash runway into early 2027 • REGENXBIO retains additional potential non-dilutive funding opportunities, including monetization of Priority Review Voucher (PRV) and milestones from AbbVie ROCKVILLE, Md., May 19, 2025 (PRNewswire) — REGENXBIO Inc. (Nasdaq: RGNX) |
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May 12, 2025 |
REGENXBIO Reports First Quarter 2025 Financial Results and Recent Operational Highlights EXHIBIT 99.1 REGENXBIO Reports First Quarter 2025 Financial Results and Recent Operational Highlights • RGX-202 in Duchenne muscular dystrophy on track for BLA submission mid-2026 o Pivotal trial more than half enrolled, with completion expected in 2025 o Additional Phase I/II functional data expected 1H 2025 o Initiating commercial supply manufacturing in Q3 2025 • FDA acceptance of Biologics Lic |
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May 12, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 00 |
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May 12, 2025 |
EXHIBIT 10.1 Confidential Executed Version Certain identified information has been excluded from this exhibit because such information both (i) is not material and (ii) is customarily and actually treated as private or confidential. Excluded information is indicated with brackets and asterisks. COLLABORATION AND LICENSE AGREEMENT BETWEEN REGENXBIO INC. AND NIPPON SHINYAKU CO., LTD. DATED AS OF JAN |
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May 12, 2025 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 12, 2025 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Number |
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April 8, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6 |
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April 8, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6 |
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March 13, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37553 REGENXBIO Inc. |
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March 13, 2025 |
EXHIBIT 4.2 Description of Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934 REGENXBIO Inc. has one class of securities registered under Section 12 of the Securities Exchange Act of 1934, as amended: our common stock, par value $0.0001 per share. The following is a general summary of the terms of shares of our common stock. The description below does |
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March 13, 2025 |
EXHIBIT 19.1 REGENXBIO INC. INSIDER TRADING POLICY (as adopted by the Board of Directors on February 23, 2024) Background The Board of Directors of REGENXBIO Inc. (the “Company”) has adopted this Insider Trading Policy (the “Policy”) for our directors, officers, employees and consultants. It applies to the trading of the Company’s securities as well as the securities of any other publicly traded c |
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March 13, 2025 |
Subsidiaries of the Registrant EXHIBIT 21.1 Subsidiaries of REGENXBIO Inc. Name of Subsidiary Jurisdiction of Incorporation or Organization REGENXBIO EU Limited Ireland |
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March 13, 2025 |
As filed with the Securities and Exchange Commission on March 13, 2025 As filed with the Securities and Exchange Commission on March 13, 2025 Registration No. |
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March 13, 2025 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1) Proposed Maximum Offering Price Per Unit(1) Maximum Aggregate Offering Price(1) Fee Rate Amount of Registration Fee Fees to be Paid Equity Common Stoc |
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March 13, 2025 |
EXHIBIT 107 Calculation of Filing Fee Tables Form S-8 (Form Type) REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1)(2) Proposed Maximum Offering Price Per Unit(3) Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Equity Common Stock, par value $0. |
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March 13, 2025 |
As filed with the Securities and Exchange Commission on March 13, 2025 POS AM Table of Contents As filed with the Securities and Exchange Commission on March 13, 2025 Registration No. |
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March 13, 2025 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 13, 2025 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Numb |
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March 13, 2025 |
As filed with the Securities and Exchange Commission on March 13, 2025 Table of Contents As filed with the Securities and Exchange Commission on March 13, 2025 Registration No. |
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March 13, 2025 |
REGENXBIO Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Updates EXHIBIT 99.1 REGENXBIO Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Updates • Biologics Licensing Application (BLA) for clemidsogene lanparvovec (RGX-121) submitted and on track for potential FDA approval 2H 2025; strategic partnership with Nippon Shinyaku aims to expand potential access and commercial opportunity in MPS II and MPS I • Pivotal trial of RGX-202 |
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March 4, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 3, 2025 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Numbe |
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March 4, 2025 |
REGENXBIO Announces Closing of Strategic Partnership with Nippon Shinyaku for MPS EXHIBIT 99.1 REGENXBIO Announces Closing of Strategic Partnership with Nippon Shinyaku for MPS Diseases ROCKVILLE, Md., March 4, 2025 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced the closing of its previously announced strategic partnership with Nippon Shinyaku. Under the terms of the agreement, REGENXBIO and Nippon Shinyaku will develop and commercialize RGX-121 (clemidsogene lanp |
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January 14, 2025 |
EX-99.1 Exhibit 99.1 REGENXBIO and Nippon Shinyaku Announce Exclusive Partnership to Develop and Commercialize RGX-121 and RGX-111 for MPS Diseases • REGENXBIO to receive $110 million upfront, potential milestone payments of up to $700 million and meaningful double-digit royalties on net sales, and lead manufacturing • Nippon Shinyaku to lead commercialization of first potential gene therapies for |
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January 14, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 14, 2025 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Nu |
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December 9, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 9, 2024 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Nu |
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December 9, 2024 |
Sales Agreement, dated as of December 9, 2024, between Leerink Partners LLC and REGENXBIO Inc. Exhibit 1.1 REGENXBIO INC. Common Stock (par value $0.0001 per share) SALES AGREEMENT December 9, 2024 LEERINK PARTNERS LLC 1301 Avenue of the Americas, 5th Floor New York, New York 10019 Ladies and Gentlemen: REGENXBIO Inc., a Delaware corporation (the “Company”), proposes, subject to the terms and conditions stated herein, to issue and sell from time to time to or through Leerink Partners LLC, a |
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December 9, 2024 |
Exhibit 107 Calculation of Filing Fee Tables 424(b)(5) (Form Type) REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Carry |
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December 9, 2024 |
Exhibit 99.1 REGENXBIO INITIATES PIVOTAL PHASE OF AFFINITY DUCHENNE® TRIAL OF RGX-202 GENE THERAPY AND REPORTS POSITIVE FUNCTIONAL DATA • Alignment achieved with FDA on AFFINITY DUCHENNE® pivotal program and access to accelerated approval; BLA expected in 2026 • Pivotal trial of RGX-202 is enrolling ambulatory patients aged 1 and above with first patient dosed • Phase I/II data show RGX-202 |
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December 9, 2024 |
Up to $150,000,000 Common Stock Filed Pursuant to Rule 424(b)(5) Registration Number 333-269086 PROSPECTUS SUPPLEMENT (To prospectus dated December 30, 2022) Up to $150,000,000 Common Stock We have entered into a sales agreement (the “Sales Agreement”) with Leerink Partners LLC, dated December 9, 2024, relating to shares of our common stock, par value $0. |
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November 14, 2024 |
RGNX / REGENXBIO Inc. / Redmile Group, LLC - SC 13G/A Passive Investment SC 13G/A 1 tm2427858d8sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 2) REGENXBIO Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 75901B107 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of this Statement) Check th |
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November 14, 2024 |
EX-99.1 2 tm2427858d8ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Joint Filing Agreement In accordance with Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the undersigned hereby agree to the joint filing on behalf of each of them of a Statement on Schedule 13G (including any and all amendments thereto, the “Schedule 13G”) relating to the Common Stock, par valu |
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November 6, 2024 |
REGENXBIO INC. CONSOLIDATED BALANCE SHEETS (in thousands) EXHIBIT 99.1 REGENXBIO Reports Third Quarter 2024 Financial Results and Recent Operational Updates • Advancement in Phase I/II AFFINITY DUCHENNE® trial of RGX-202 for Duchenne Muscular Dystrophy; pivotal trial initiation and first functional data expected this month • BLA submission for RGX-121 initiated and expected to complete in Q1 2025 • Positive Phase II data support bilateral administration |
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November 6, 2024 |
EXHIBIT 10.1 September 14, 2024 Vittal Vasista 1218 Harve Lafitte Drive Austin, TX 78746 Dear Vit: This letter (“Agreement”) confirms the details of your separation from REGENXBIO Inc. (“REGENXBIO” or the “Company”), and all subsidiaries, successors, affiliated and/or related entities (collectively referred to as “REGENXBIO” or the “Company”). While these matters are never easy, we hope that your |
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November 6, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 06, 2024 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File N |
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November 6, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Numbe |
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November 6, 2024 |
Consulting Agreement, effective as of September 16, 2024, between the Registrant and Vittal Vasista EXHIBIT 10.2 Consulting Agreement This Consulting Agreement (the “Agreement”) is entered into as of September 16, 2024, by and between REGENXBIO Inc. (“REGENXBIO”), a Delaware corporation with offices at 9804 Medical Center Drive, Rockville, Maryland 20850, and Vittal Vasista (“Consultant”), an individual with an address at 1218 Harve Lafitte Drive, Austin, TX 78746 each a “Party” and collectively |
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October 17, 2024 |
RGNX / REGENXBIO Inc. / JPMORGAN CHASE & CO - FILING REGENXBIO INC. Passive Investment SC 13G/A 1 REGENXBIOInc.htm FILING REGENXBIO INC. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 05)* REGENXBIO Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 75901B107 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of this Statement |
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September 17, 2024 |
REGENXBIO Appoints Mitchell Chan as Chief Financial Officer EXHIBIT 99.1 REGENXBIO Appoints Mitchell Chan as Chief Financial Officer • Life sciences veteran Mitchell Chan joins the company ahead of multiple catalysts across late-stage gene therapy programs • Vit Vasista steps down following more than 15 years at the Company ROCKVILLE, Md. - September 17, 2024 - REGENXBIO Inc. (Nasdaq: RGNX) today announced that Mitchell Chan has been appointed as Executive |
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September 17, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 16, 2024 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File |
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August 6, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 1, 2024 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Numb |
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August 1, 2024 |
EXHIBIT 10.2 Agreement This Consulting and Employment Separation Agreement (the “Agreement”) is entered into as of June 12, 2024, by and between REGENXBIO Inc. (“REGENXBIO”), a Delaware corporation with offices at 9804 Medical Center Drive, Rockville, Maryland 20850, and Ken Mills (“Mr. Mills”), (each a “Party” and collectively the “Parties”). WHEREAS, Mr. Mills will voluntarily resign from his ro |
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August 1, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001 |
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August 1, 2024 |
REGENXBIO Reports Second Quarter 2024 Financial Results and Recent Operational Highlights EXHIBIT 99.1 REGENXBIO Reports Second Quarter 2024 Financial Results and Recent Operational Highlights • Company remains on track for its first BLA filing in 2024 and is accelerating progress toward pivotal trial initiation for Duchenne (H2 2024) and diabetic retinopathy (H1 2025) o New, positive data from Phase II AFFINITY DUCHENNE® trial of RGX-202 demonstrates consistent high expression of micr |
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August 1, 2024 |
Employment Agreement effective as of July 1, 2024 between the Registrant and Curran Simpson EXHIBIT 10.1 This Employment Agreement (this "Agreement") is entered into and made effective as of July 1. 2024, by and between Curran Simpson (the "Employee") and REGENXBIO Inc., a Delaware corporation (the "Company"). 1. Position. (a) During your employment with the Company pursuant to this Agreement, you will hold the title of President & Chief Executive Officer (CEO). As CEO you shall report d |
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August 1, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 01, 2024 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Num |
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June 13, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 12, 2024 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Numbe |
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June 13, 2024 |
REGENXBIO Announces Leadership Transition Exhibit 99.1 REGENXBIO Announces Leadership Transition - Curran Simpson, Chief Operating Officer, Appointed as President and CEO - Co-Founder Kenneth T. Mills to Step Down as President and CEO; Named Chairman of the Board ROCKVILLE, Md. — June 12, 2024 — REGENXBIO Inc. (Nasdaq: RGNX) today announced that Curran Simpson, Chief Operating Officer, has been appointed as President, Chief Executive Offi |
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June 3, 2024 |
Financial Statements and Exhibits, Submission of Matters to a Vote of Security Holders UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 31, 2024 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Number |
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May 8, 2024 |
REGENXBIO Reports First Quarter 2024 Financial Results and Recent Operational Highlights EXHIBIT 99.1 REGENXBIO Reports First Quarter 2024 Financial Results and Recent Operational Highlights • Company remains on track for its first BLA filing in 2024 and is accelerating progress toward pivotal trial initiation for Duchenne (H2 2024) and diabetic retinopathy (H1 2025) • Dose level 2 selected as pivotal dose for RGX-202 treatment of Duchenne o New positive interim efficacy and safety da |
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May 8, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 08, 2024 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Number |
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May 8, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 00 |
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April 4, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6 |
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April 4, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6 |
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March 11, 2024 |
Exhibit 1.1 REGENXBIO INC. 4,565,260 SHARES OF COMMON STOCK (PAR VALUE $0.0001 PER SHARE) AND PRE- FUNDED WARRANTS TO PURCHASE 1,521,740 SHARES OF COMMON STOCK UNDERWRITING AGREEMENT March 6, 2024 March 6, 2024 Morgan Stanley & Co. LLC Goldman Sachs & Co. LLC Barclays Capital Inc. Stifel, Nicolaus & Company, Incorporated c/o Morgan Stanley & Co. LLC 1585 Broadway New York, New York 10036 c/o Goldm |
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March 11, 2024 |
Exhibit 4.1 REGENXBIO INC. FORM OF WARRANT TO PURCHASE COMMON STOCK Number of Shares: [●] (subject to adjustment) Warrant No. [●] Original Issue Date: March [ ], 2024 REGENXBIO Inc., a Delaware corporation (the “Company”), hereby certifies that, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, [●] or its permitted registered assigns (the “Holder”), |
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March 11, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 6, 2024 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Numbe |
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March 11, 2024 |
REGENXBIO Announces Pricing of Upsized Public Offering of Common Stock and Pre-funded Warrants Exhibit 99.1 REGENXBIO Announces Pricing of Upsized Public Offering of Common Stock and Pre-funded Warrants ROCKVILLE, Md., March 6, 2024 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy, today announced the pricing of an underwritten upsized public offering of 4,565,260 shares of its |
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March 8, 2024 |
4,565,260 shares of Common Stock 1,521,740 Pre-funded Warrants to Purchase Shares of Common Stock Table of Contents Filed pursuant to Rule 424(b)(5) Registration No. 333-269086 Prospectus Supplement (To Prospectus dated December 30, 2022) 4,565,260 shares of Common Stock 1,521,740 Pre-funded Warrants to Purchase Shares of Common Stock We are offering 4,565,260 shares of our common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of our common stoc |
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March 8, 2024 |
Exhibit 107 Calculation of Filing Fee Tables 424(b)(5) (Form Type) REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee(1) Fees to Be Pa |
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March 7, 2024 |
REGENXBIO INC. Common Stock Pre-funded Warrants to Purchase Shares of Common Stock FWP 1 d764729dfwp.htm FWP Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Dated March 6, 2024 Relating to Preliminary Prospectus Supplement Dated March 6, 2024 Registration Statement No. 333-269086 REGENXBIO INC. Common Stock Pre-funded Warrants to Purchase Shares of Common Stock This free writing prospectus relates only to the public offering of shares of common stock and pre-funded war |
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March 6, 2024 |
Subject to completion, dated March 6, 2024 Table of Contents Filed pursuant to Rule 424(b)(5) Registration No. 333-269086 The information in this preliminary prospectus supplement and the accompanying prospectus is not complete and may be changed. This preliminary prospectus supplement and the accompanying prospectus are not an offer to sell these securities and are not soliciting an offer to buy these securities in any jurisdiction where |
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February 27, 2024 |
EXHIBIT 99.1 REGENXBIO Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Operational Highlights • Focus on clinical stage AAV Therapeutic product candidates addressing large commercial opportunities and value generation • Prioritized pipeline is expected to further progress to pivotal stage and first BLA filing in 2024 • New updates planned for Duchenne and in-office delivery |
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February 27, 2024 |
EXHIBIT 107 Calculation of Filing Fee Tables Form S-8 (Form Type) REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1)(2) Proposed Maximum Offering Price Per Unit(3) Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Equity Common Stock, par value $0. |
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February 27, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37 |
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February 27, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 27, 2024 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File N |
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February 27, 2024 |
As filed with the Securities and Exchange Commission on February 27, 2024 As filed with the Securities and Exchange Commission on February 27, 2024 Registration No. |
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February 27, 2024 |
Form of Employment Agreement for Executive Vice Presidents EXHIBIT 10.9 [Letterhead of REGENXBIO Inc.] This Employment Agreement (this "Agreement") is entered into and made effective as of , by and between (the "Employee") and REGENXBIO Inc., a Delaware corporation (the "Company"). 1. Position. (a) During your employment with the Company pursuant to this Agreement, you will hold the title of . As the you shall report directly to the. By signing this Agree |
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February 27, 2024 |
EXHIBIT 97.1 REGENXBIO INC. COMPENSATION CLAWBACK POLICY Adopted November 30, 2023 Purpose The Board of Directors (the “Board”) of REGENXBIO Inc. (the “Company”) has adopted this compensation clawback policy (the “Policy”) which provides for the recoupment of Incentive-Based Compensation (as defined below) in the event of an Accounting Restatement (as defined below). This Policy is intended to com |
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February 27, 2024 |
Subsidiaries of the Registrant EXHIBIT 21.1 Subsidiaries of REGENXBIO Inc. Name of Subsidiary Jurisdiction of Incorporation or Organization REGENXBIO EU Limited Ireland |
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February 14, 2024 |
RGNX / REGENXBIO Inc. / Redmile Group, LLC - SC 13G/A Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1) REGENXBIO Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 75901B107 (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pur |
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February 14, 2024 |
EX-99.1 2 tm245846d9ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Joint Filing Agreement In accordance with Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the undersigned hereby agree to the joint filing on behalf of each of them of a Statement on Schedule 13G (including any and all amendments thereto, the “Schedule 13G”) relating to the Common Stock, par value |
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February 13, 2024 |
RGNX / REGENXBIO Inc. / VANGUARD GROUP INC - SCHEDULE 13G/A Passive Investment SC 13G/A 1 tv01801-regenxbioinc.htm SCHEDULE 13G/A SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No.: 6)* Name of issuer: REGENXBIO Inc Title of Class of Securities: Common Stock CUSIP Number: 75901B107 Date of Event Which Requires Filing of this Statement: December 29, 2023 Check the appropriate box to designate the rul |
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February 5, 2024 |
RGNX / REGENXBIO Inc. / GIC Private Ltd - SC 13G/A Passive Investment SC 13G/A 1 ef20020646sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1) * REGENXBIO Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title of Class of Securities) 75901B107 (CUSIP Number) December 31, 2023 (Date of the Event Which Requires Filing of this Statement) Chec |
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January 25, 2024 |
RGNX / REGENXBIO Inc. / JPMORGAN CHASE & CO - FILING REGENXBIO INC. Passive Investment Schedule 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 04)* REGENXBIO Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 75901B107 (CUSIP Number) December 29, 2023 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designa |
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January 25, 2024 |
RGNX / REGENXBIO Inc. / JPMORGAN CHASE & CO - FILING REGENXBIO INC. Passive Investment Schedule 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 04)* REGENXBIO Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 75901B107 (CUSIP Number) December 29, 2023 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designa |
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November 17, 2023 |
RGNX / Regenxbio Inc / Redmile Group, LLC - SC 13G Passive Investment SC 13G 1 tm2331039d1sc13g.htm SC 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. ) REGENXBIO Inc. (Name of Issuer) Common Stock, $0.0001 per share (Title of Class of Securities) 75901B107 (CUSIP Number) November 9, 2023 (Date of Event Which Requires Filing of this State |
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November 17, 2023 |
EX-99.1 2 tm2331039d1ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Joint Filing Agreement In accordance with Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the undersigned hereby agree to the joint filing on behalf of each of them of a Statement on Schedule 13G (including any and all amendments thereto, the “Schedule 13G”) relating to the Common Stock, $0.0 |
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November 8, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 08, 2023 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File N |
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November 8, 2023 |
REGENXBIO INC. CONSOLIDATED BALANCE SHEETS (in thousands) EXHIBIT 99.1 REGENXBIO Announces Updated Strategic Plans and Third Quarter 2023 Financial Results • Announces pipeline prioritization and corporate restructuring to focus on clinical stage AAV Therapeutic product candidates addressing large commercial opportunities and value generation • Highest priority programs are ABBV-RGX-314 for the treatment of wet AMD and diabetic retinopathy, being develop |
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November 8, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Numbe |
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September 1, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 1, 2023 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File N |
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September 1, 2023 |
EX-FILING FEES Exhibit 107 Calculation of Filing Fee Tables 424(b)(5) (Form Type) REGENXBIO Inc. |
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September 1, 2023 |
Exhibit 1.1 REGENXBIO INC. Common Stock (par value $0.0001 per share) ATM EQUITY OFFERINGSM SALES AGREEMENT September 1, 2023 BofA Securities, Inc. One Bryant Park New York, New York 10036 Ladies and Gentlemen: REGENXBIO Inc., a Delaware corporation (the “Company”), proposes, subject to the terms and conditions stated herein, to issue and sell from time to time to or through BofA Securities, Inc., |
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September 1, 2023 |
Table of Contents Filed Pursuant to Rule 424(b)(5) Registration Number 333-269086 PROSPECTUS SUPPLEMENT (To prospectus dated December 30, 2022) $150,000,000 Common Stock We have entered into an ATM Equity OfferingSM Sales Agreement (the “Sales Agreement”) with BofA Securities, Inc. |
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August 4, 2023 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered(1) Proposed Maximum Offering Price Per Unit(2) Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Ca |
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August 4, 2023 |
As filed with the Securities and Exchange Commission on August 4, 2023 S-3ASR Table of Contents As filed with the Securities and Exchange Commission on August 4, 2023 Registration No. |
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August 2, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 02, 2023 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Num |
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August 2, 2023 |
REGENXBIO Reports Second Quarter 2023 Financial Results and Recent Operational Highlights EXHIBIT 99.1 REGENXBIO Reports Second Quarter 2023 Financial Results and Recent Operational Highlights • Continued progress on ‘5x’25’ strategy to advance five AAV Therapeutics from REGENXBIO’s internal pipeline and licensed programs into pivotal-stage or commercial products by 2025 • ABBV-RGX-314 program for the treatment of wet AMD and diabetic retinopathy, being developed in collaboration with |
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August 2, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001 |
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June 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 02, 2023 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Numbe |
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May 10, 2023 |
RGNX / Regenxbio Inc / VANGUARD GROUP INC - SCHEDULE 13G/A Passive Investment SC 13G/A 1 tv0005-regenxbioinc.htm SCHEDULE 13G/A SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No.: 5)* Name of issuer: REGENXBIO Inc. Title of Class of Securities: Common Stock CUSIP Number: 75901B107 Date of Event Which Requires Filing of this Statement: April 28, 2023 Check the appropriate box to designate the rule p |
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May 3, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 00 |
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May 3, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 03, 2023 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Number |
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May 3, 2023 |
REGENXBIO Reports First Quarter 2023 Financial Results and Recent Operational Highlights EXHIBIT 99.1 REGENXBIO Reports First Quarter 2023 Financial Results and Recent Operational Highlights - Continued progress on ‘5x’25’ strategy to advance five AAV Therapeutics from REGENXBIO’s internal pipeline and licensed programs into pivotal-stage or commercial products by 2025 - Announced Updates to Eye Care Collaboration with AbbVie o Investigational gene therapy renamed ABBV-RGX-314 o IND s |
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April 7, 2023 |
RGNX / Regenxbio Inc / GIC Private Ltd - SC 13G Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. ) * REGENXBIO Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title of Class of Securities) 75901B107 (CUSIP Number) March 31, 2023 (Date of the Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule p |
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April 6, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6 |
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April 6, 2023 |
Definitive Proxy Statement on Schedule 14A, as filed with the SEC on April 6, 2023; UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6 |
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February 28, 2023 |
EXHIBIT 99.1 REGENXBIO Reports Fourth Quarter 2022 and Full-Year 2022 Financial Results and Recent Operational Highlights - Continued progress on ‘5x’25’ strategy to advance five AAV Therapeutics from REGENXBIO’s internal pipeline and licensed programs into pivotal-stage or commercial products by 2025 - RGX-314 program for the treatment of wet AMD and diabetic retinopathy, being developed in colla |
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February 28, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 28, 2023 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File N |
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February 28, 2023 |
EXHIBIT 107 Calculation of Filing Fee Tables Form S-8 (Form Type) REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1)(2) Proposed Maximum Offering Price Per Unit(3) Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Equity Common Stock, par value $0. |
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February 28, 2023 |
Subsidiaries of the Registrant EXHIBIT 21.1 Subsidiaries of REGENXBIO Inc. Name of Subsidiary Jurisdiction of Incorporation or Organization REGENXBIO EU Limited Ireland |
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February 28, 2023 |
As filed with the Securities and Exchange Commission on February 28, 2023 As filed with the Securities and Exchange Commission on February 28, 2023 Registration No. |
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February 28, 2023 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37 |
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February 9, 2023 |
RGNX / Regenxbio Inc / VANGUARD GROUP INC - SCHEDULE 13G/A Passive Investment SC 13G/A 1 tv01774-regenxbioinc.htm SCHEDULE 13G/A SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No.: 4)* Name of issuer: REGENXBIO Inc. Title of Class of Securities: Common Stock CUSIP Number: 75901B107 Date of Event Which Requires Filing of this Statement: December 30, 2022 Check the appropriate box to designate the ru |
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January 27, 2023 |
RGNX / Regenxbio Inc / JPMORGAN CHASE & CO - FILING REGENXBIO INC. Passive Investment Schedule 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 03)* REGENXBIO Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title of Class of Securities) 75901B107 (CUSIP Number) December 30, 2022 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designa |
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January 10, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 09, 2023 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File Nu |
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January 10, 2023 |
REGENXBIO ANNOUNCES SENIOR LEADERSHIP PROMOTIONS Exhibit 99.1 REGENXBIO ANNOUNCES SENIOR LEADERSHIP PROMOTIONS • Curran Simpson has been appointed Chief Operating Officer • Shiva Fritsch assumes the role of Chief Communications Officer ROCKVILLE, Md., Jan. 9, 2023, REGENXBIO Inc. (Nasdaq: RGNX) today announced the promotion of Curran Simpson from Chief Technology and Operations Officer to Chief Operating Officer. In addition, Shiva Fritsch has b |
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December 30, 2022 |
EX-FILING FEES 4 d439458dexfilingfees.htm EX-FILING FEES Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Of |
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December 30, 2022 |
As filed with the Securities and Exchange Commission on December 30, 2022 Table of Contents As filed with the Securities and Exchange Commission on December 30, 2022 Registration No. |
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November 3, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Numbe |
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November 3, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 03, 2022 REGENXBIO Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37553 47-1851754 (State or Other Jurisdiction of Incorporation) (Commission File N |
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November 3, 2022 |
REGENXBIO Reports Third Quarter 2022 Financial Results and Recent Operational Highlights EXHIBIT 99.1 REGENXBIO Reports Third Quarter 2022 Financial Results and Recent Operational Highlights - Continued progress on 5x25 strategy to advance five AAV Therapeutics from our internal pipeline and licensed programs into pivotal-stage or commercial products by 2025 - RGX-314 program for the treatment of wet AMD and diabetic retinopathy, being developed in collaboration with AbbVie, remains o |
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August 3, 2022 |
REGENXBIO Reports Second Quarter 2022 Financial Results and Recent Operational Highlights EXHIBIT 99.1 REGENXBIO Reports Second Quarter 2022 Financial Results and Recent Operational Highlights - RGX-314 program for the treatment of wet AMD and diabetic retinopathy, being developed in collaboration with AbbVie, remains on track for first BLA filing in 2024 o Enrollment ongoing in the pivotal ATMOSPHERE? and ASCENT? clinical trials of RGX-314 for the treatment of wet AMD using subretinal |
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August 3, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001 |
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August 3, 2022 |
Compensation Program for Non-Employee Directors EXHIBIT 10.1 REGENXBIO INC. COMPENSATION PROGRAM FOR NON-EMPLOYEE DIRECTORS (as amended on June 3, 2022) A. Cash Compensation 1. Board retainer: $45,000 per year for each non-employee director, paid in quarterly installments in arrears. 2. Chairman of the Board retainer: $35,000 per year, paid in quarterly installments in arrears. 3. Lead Independent Director retainer: $25,000 per year, paid in qu |
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August 3, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 3, 2022 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Numb |
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June 7, 2022 |
Jennifer Zachary Joins REGENXBIO Board of Directors Exhibit 99.1 Jennifer Zachary Joins REGENXBIO Board of Directors ROCKVILLE, Md., June 7, 2022 (PRNewswire) ? REGENXBIO Inc. (Nasdaq: RGNX) today announced the appointment of Jennifer Zachary to its Board of Directors, effective June 3, 2022. Ms. Zachary will serve as a member of REGENXBIO?s Audit Committee and brings 20 years of legal and regulatory experience working in the pharmaceutical and med |
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June 7, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 3, 2022 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Number |
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May 4, 2022 |
EXHIBIT 10.1 Certain identified information has been excluded from this exhibit because such information both (i) is not material and (ii) would likely cause competitive harm if publicly disclosed. Excluded information is indicated with brackets and asterisks. [Letterhead of Penn Center for Innovation] March 21, 2022 VIA ELECTRONIC MAIL CONFIDENTIAL Ken Mills, President and CEO REGENXBIO Inc. 9804 |
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May 4, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 00 |
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May 4, 2022 |
REGENXBIO Reports First Quarter 2022 Financial Results and Recent Operational Highlights EXHIBIT 99.1 REGENXBIO Reports First Quarter 2022 Financial Results and Recent Operational Highlights - Continues to advance RGX-314 program for the treatment of wet AMD and diabetic retinopathy; remains on track for first BLA filing in 2024 o Enrollment ongoing in the pivotal ATMOSPHERE? and ASCENT? clinical trials of RGX-314 for the treatment of wet AMD using subretinal delivery o Enrollment ong |
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May 4, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 4, 2022 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Number) |
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April 7, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ? Filed by a party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, for Use of the Commission Only (as permitted by Rule 14a-6 |
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April 7, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ? Filed by a party other than the Registrant ? Check the appropriate box: ?Preliminary Proxy Statement ?Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e |
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March 25, 2022 |
Entry into a Material Definitive Agreement UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 21, 2022 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Numb |
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March 18, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 14, 2022 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Numb |
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March 1, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 1, 2022 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Numbe |
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March 1, 2022 |
EXHIBIT 4.2 Description of Registrant?s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934 REGENXBIO Inc. has one class of securities registered under Section 12 of the Securities Exchange Act of 1934, as amended: our common stock, par value $0.0001 per share. The following is a general summary of the terms of shares of our common stock. The description below does |
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March 1, 2022 |
EX-99.1 2 rgnx-ex99124.htm EX-99.1 EXHIBIT 99.1 REGENXBIO Reports Fourth Quarter and Full-Year 2021 Financial Results and Recent Operational Highlights - Closed eye care collaboration agreement with AbbVie to develop and commercialize RGX-314 o Received upfront payment of $370 million and eligible to receive up to $1.38 billion in additional development, regulatory and commercial milestones - Cont |
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March 1, 2022 |
As filed with the Securities and Exchange Commission on March 1, 2022 As filed with the Securities and Exchange Commission on March 1, 2022 Registration No. |
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March 1, 2022 |
EXHIBIT 10.40 Certain identified information has been excluded from this exhibit pursuant to Item 601(b)(10)(iv) of Regulation S-K because such information both (i) is not material and (ii) would likely cause competitive harm if publicly disclosed. Excluded information is indicated with brackets and asterisks. SETTLEMENT AGREEMENT AND MUTUAL RELEASE This Settlement Agreement and Mutual Release (?S |
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March 1, 2022 |
EXHIBIT 107 Calculation of Filing Fee Tables Form S-8 (Form Type) REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1) Proposed Maximum Offering Price Per Unit(3) Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Equity Common Stock, par value $0.000 |
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March 1, 2022 |
Subsidiaries of the Registrant EXHIBIT 21.1 Subsidiaries of REGENXBIO Inc. Name of Subsidiary Jurisdiction of Incorporation or Organization REGENXBIO EU Limited Ireland |
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March 1, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ? ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 or ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37 |
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February 14, 2022 |
RGNX / Regenxbio Inc / Redmile Group, LLC - SCHEDULE 13G/A Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 2) REGENXBIO Inc. (Name of Issuer) Common Stock, $0.0001 per share (Title of Class of Securities) 75901B107 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to |
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February 14, 2022 |
Exhibit 99.1 Joint Filing Agreement In accordance with Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, as amended (the ?Exchange Act?), the undersigned hereby agree to the joint filing on behalf of each of them of a Statement on Schedule 13G (including any and all amendments thereto, the ?Schedule 13G?) relating to the Common Stock, $0.0001 par value per share, of REGENXBIO Inc., which |
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February 14, 2022 |
Exhibit 99.1 REGENXBIO Presents Positive Interim Data from Phase II ALTITUDE? Trial of RGX-314 for the Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery ? 47% of patients in Cohort 1 treated with RGX-314 demonstrated a ?2 step improvement from baseline on the ETDRS-DRSS at six months, compared to 0% of patients in observational control; increase from 33% of patients at three months ? |
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February 14, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 12, 2022 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File N |
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February 11, 2022 |
RGNX / Regenxbio Inc / GIC Private Ltd - SC 13G/A Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 2) * REGENXBIO Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title of Class of Securities) 75901B107 (CUSIP Number) December 31, 2021 (Date of the Event Which Requires Filing of this Statement) Check the appropriate box to designate the ru |
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February 10, 2022 |
RGNX / Regenxbio Inc / VANGUARD GROUP INC - SCHEDULE 13G/A Passive Investment SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No.: 3)* Name of issuer: REGENXBIO Inc. Title of Class of Securities: Common Stock CUSIP Number: 75901B107 Date of Event Which Requires Filing of this Statement: December 31, 2021 Check the appropriate box to designate the rule pursuant to which this Schedule is filed: ☒ Rule |
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February 9, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 9, 2022 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Nu |
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February 9, 2022 |
EXHIBIT 99.1 REGENXBIO Presents Additional Positive Interim Data from Phase I/II Trial of RGX-121 for the Treatment of MPS II (Hunter Syndrome) at 18th Annual WORLDSymposiumTM 2022 ? RGX-121, a one-time gene therapy for MPS II, continues to be well-tolerated with no drug-related SAEs across three dose levels ? Dose-dependent reductions in CSF biomarkers observed; Cohort 3 patients approach normal |
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February 9, 2022 |
EXHIBIT 99.2 REGENXBIO Presents Positive Initial Data from Phase I/II Trial of RGX-111 for the Treatment of Severe MPS I at 18th Annual WORLDSymposiumTM 2022 ? RGX-111, a potential one-time gene therapy for MPS I, is well-tolerated across two dose levels, with no drug-related serious adverse events ? Biomarker and neurodevelopmental assessments indicate encouraging CNS profile in patients dosed wi |
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January 18, 2022 |
RGNX / Regenxbio Inc / JPMORGAN CHASE & CO - FILING REGENXBIO INC. Passive Investment Schedule 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 02)* REGENXBIO Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title of Class of Securities) 75901B107 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designa |
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November 15, 2021 |
Entry into a Material Definitive Agreement UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 12, 2021 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File N |
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November 12, 2021 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 12, 2021 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File N |
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November 12, 2021 |
Exhibit 99.1 REGENXBIO Presents Additional Positive Interim Data from Trials of RGX-314 in Wet AMD and Diabetic Retinopathy Using Suprachoroidal Delivery at AAO 2021 ? Suprachoroidal delivery of RGX-314 in Phase II AAVIATE? trial for the treatment of wet AMD continues to be well tolerated in 50 patients from Cohorts 1-3 with no drug-related serious adverse events ? Positive initial data from Cohor |
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November 9, 2021 |
REGENXBIO Announces Closing of Eye Care Collaboration Agreement with AbbVie Exhibit 99.1 REGENXBIO Announces Closing of Eye Care Collaboration Agreement with AbbVie ROCKVILLE, Md., November 9, 2021 ? REGENXBIO Inc. (Nasdaq: RGNX) today announced the closing of its Collaboration and License Agreement with AbbVie to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy ( |
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November 9, 2021 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 8, 2021 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Nu |
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November 9, 2021 |
RGNX / Regenxbio Inc / JPMORGAN CHASE & CO - FILING REGENXBIO INC. Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 01)* REGENXBIO Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title of Class of Securities) 75901B107 (CUSIP Number) October 29, 2021 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pu |
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November 2, 2021 |
EXHIBIT 10.1 EXECUTED VERSION Certain identified information has been excluded from this exhibit because such information both (i) is not material and (ii) would likely cause competitive harm if publicly disclosed. Excluded information is indicated with brackets and asterisks. COLLABORATION AND LICENSE AGREEMENT BETWEEN regenxbio inc. AND ABBVIE GLOBAL ENTERPRISES LTD. DATED AS OF September 10, 20 |
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November 2, 2021 |
REGENXBIO Reports Third Quarter 2021 Financial Results and Operational Highlights EXHIBIT 99.1 REGENXBIO Reports Third Quarter 2021 Financial Results and Operational Highlights ? Announced eye care collaboration with AbbVie to develop and commercialize RGX-314 o AbbVie and REGENXBIO form a strategic partnership combining eye care and gene therapy expertise o REGENXBIO to receive $370 million upfront payment o Transaction expected to close by end of 2021, subject to satisfaction |
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November 2, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 2, 2021 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Nu |
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November 2, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Numbe |
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October 12, 2021 |
Exhibit 99.1 REGENXBIO Presents Positive Initial Data from Phase II ALTITUDE? Trial of RGX-314 for the Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery at American Society of Retina Specialists Annual Meeting ? Suprachoroidal delivery of RGX-314 well tolerated in 15 patients in Cohort 1 with no drug-related serious adverse events ? No intraocular inflammation observed ? Positive int |
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October 12, 2021 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 9, 2021 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Num |
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October 1, 2021 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 1, 2021 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Num |
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October 1, 2021 |
Exhibit 99.1 REGENXBIO Presents Positive Initial Data from Phase II AAVIATE? Trial of RGX-314 for the Treatment of Wet AMD Using Suprachoroidal Delivery and Provides Trial Update at Retina Society 54th Annual Scientific Meeting ? Suprachoroidal delivery of RGX-314 well tolerated in 50 patients in Cohorts 1-3 with no drug-related serious adverse events ? Positive initial data from Cohort 1 at six m |
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September 13, 2021 |
Exhibit 99.1 PRESS RELEASE AbbVie and REGENXBIO Announce Eye Care Collaboration ? AbbVie and REGENXBIO form a strategic partnership combining eye care and gene therapy expertise ? Companies will develop and commercialize RGX-314, an investigational gene therapy for wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases ? REGENXBIO to receive $370 million upfr |
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September 13, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 10, 2021 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File |
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September 7, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 3, 2021 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File N |
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September 7, 2021 |
Dr. Jean Bennett and George Migausky Join REGENXBIO Board of Directors EXHIBIT 99.1 Dr. Jean Bennett and George Migausky Join REGENXBIO Board of Directors ? Renowned gene therapy pioneer and biotechnology executive bring extensive R&D leadership and financial and operational expertise to the Board ROCKVILLE, Md., September 7, 2021 ? REGENXBIO Inc. (Nasdaq: RGNX) today announced the appointment of Jean Bennett, M.D., Ph.D., and George Migausky to its Board of Director |
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August 9, 2021 |
REGENXBIO Reports Second Quarter 2021 Financial Results and Operational Highlights EXHIBIT 99.1 REGENXBIO Reports Second Quarter 2021 Financial Results and Operational Highlights ? Enrollment in RGX-314 programs is on-track, including the pivotal program for the treatment of wet AMD utilizing subretinal delivery, and the Phase II trials for the treatment of wet AMD and DR utilizing in-office suprachoroidal delivery ? Interim data from RGX-314 Phase II trial for the treatment of |
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August 9, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001 |
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August 9, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 9, 2021 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Numb |
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July 16, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 13, 2021 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Numbe |
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June 7, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 4, 2021 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Number |
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June 7, 2021 |
Exhibit 3.1 RESTATED CERTIFICATE OF INCORPORATION OF REGENXBIO INC. (Pursuant to Sections 242 and 245 of the Delaware General Corporation Law) REGENXBIO Inc., a corporation organized and existing under and by virtue of the provisions of the Delaware General Corporation Law, DOES HEREBY CERTIFY: FIRST:That the name of the corporation is REGENXBIO Inc. and that this corporation was originally incorp |
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May 5, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 5, 2021 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Number) |
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May 5, 2021 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 00 |
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May 5, 2021 |
REGENXBIO Reports First Quarter 2021 Financial Results and Operational Highlights EXHIBIT 99.1 REGENXBIO Reports First Quarter 2021 Financial Results and Operational Highlights ? Enrollment ongoing in ATMOSPHERE?, the first of two planned pivotal trials for the subretinal delivery of RGX-314 for the treatment of wet AMD ? Continued progress and expansion of Phase II AAVIATE? trial of RGX-314 utilizing in-office suprachoroidal delivery for the treatment of wet AMD ? Began dosing |
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April 19, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ?Filed by a party other than the Registrant ? Check the appropriate box: ?Preliminary Proxy Statement ?Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e) |
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April 19, 2021 |
definitive proxy statement on Schedule 14A for the 2021 Annual Meeting of Stockholders UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ? Filed by a party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, for Use of the Commission Only (as permitted by Rule 14a-6 |
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April 8, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ? Filed by a party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, for Use of the Commission Only (as permitted by Rule 14a-6 |
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March 1, 2021 |
EXHIBIT 10.5 REGENXBIO Inc. 2015 Equity Incentive Plan Notice of Stock Option Grant You have been granted the following option to purchase shares of the common stock of REGENXBIO Inc. (the ?Company?): Name of Optionee: [Participant Name] Total Number of Shares: [Number of Units] Type of Option: [Incentive Stock Option or Nonstatutory Stock Option] Exercise Price per Share: [Exercise Price] Date of |
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March 1, 2021 |
EXHIBIT 10.4 REGENXBIO Inc. 2015 Equity Incentive Plan Notice of Restricted Stock Unit Award You have been granted units representing shares of Common Stock of REGENXBIO Inc. (the ?Company?) on the following terms: Name of Recipient: [Participant Name] Total Number of Units Granted: [Number of Units] Date of Grant: [Grant Date] Vesting Schedule: [Vesting Schedule] You and the Company agree that th |
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March 1, 2021 |
EXHIBIT 4.2 Description of Registrant?s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934 REGENXBIO Inc. has one class of securities registered under Section 12 of the Securities Exchange Act of 1934, as amended: our common stock, par value $0.0001 per share. The following is a general summary of the terms of shares of our common stock. The description below does |
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March 1, 2021 |
REGENXBIO Reports Fourth Quarter and Full-Year 2020 Financial Results and Operational Highlights EXHIBIT 99.1 FOR IMMEDIATE RELEASE REGENXBIO Reports Fourth Quarter and Full-Year 2020 Financial Results and Operational Highlights • Pivotal program for subretinal delivery of RGX-314 for the treatment of wet AMD is active and enrolling patients; expected to support BLA filing in 2024 • Phase II trials of RGX-314 utilizing in-office suprachoroidal delivery for treatment of wet AMD and diabetic re |
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March 1, 2021 |
Registration Statement on Form S-8 filed on March 1, 2021 As filed with the Securities and Exchange Commission on March 1, 2021 Registration No. |
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March 1, 2021 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ? ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 or ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37 |
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March 1, 2021 |
Subsidiaries of the Registrant EXHIBIT 21.1 Subsidiaries of REGENXBIO Inc. Name of Subsidiary Jurisdiction of Incorporation or Organization REGENXBIO EU Limited Ireland |
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March 1, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 1, 2021 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Numbe |
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March 1, 2021 |
EXHIBIT 10.42 Certain identified information has been excluded from this exhibit because such information both (i) is not material and (ii) would likely cause competitive harm if publicly disclosed. Excluded information is indicated with brackets and asterisks. Royalty Purchase Agreement Between REGENXBIO Inc., as Seller the entities set forth on Schedule 1.1 HERETO, as Purchaser, and HCR COLLATER |
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February 16, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 1) REGENXBIO Inc. (Name of Issuer) Common Stock, $0.0001 per share (Title of Class of Securities) 75901B107 (CUSIP Number) December 31, 2020 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to |
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February 16, 2021 |
Exhibit 99.1 Joint Filing Agreement In accordance with Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the undersigned hereby agree to the joint filing on behalf of each of them of a Statement on Schedule 13G (including any and all amendments thereto, the “Schedule 13G”) relating to the Common Stock, $0.0001 par value per share, of REGENXBIO Inc., which |
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February 12, 2021 |
SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* Prevail Therapeutics Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 74140Y101 (CUSIP Number) December 31, 2020 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to d |
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February 12, 2021 |
SC 13G/A SCHEDULE 13G CUSIP No. 75901B107 Page 1 of 5 Pages UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1) * REGENXBIO Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title of Class of Securities) 75901B107 (CUSIP Number) December 31, 2020 (Date of the Event Which Requires Filing of t |
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February 12, 2021 |
AGREEMENT REGARDING THE JOINT FILING OF AMENDMENT NO. 3 TO SCHEDULE 13G Exhibit 1 AGREEMENT REGARDING THE JOINT FILING OF AMENDMENT NO. 3 TO SCHEDULE 13G The undersigned hereby agree as follows: (i) each of them is individually eligible to use the Amendment No. 3 on Schedule 13G to which this Exhibit is attached, and such Amendment No. 3 to Schedule 13G is filed on behalf of each of them; and (ii) each of them is responsible for the timely filing of such Amendment No. |
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February 12, 2021 |
SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 3)* REGENXBIO Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 75901B107 (CUSIP Number) December 31, 2020 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate th |
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February 10, 2021 |
SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No.: 2)* Name of issuer: REGENXBIO Inc. Title of Class of Securities: Common Stock CUSIP Number: 75901B107 Date of Event Which Requires Filing of this Statement: December 31, 2020 Check the appropriate box to designate the rule pursuant to which this Schedule is filed: ☒ Rule |
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January 15, 2021 |
Schedule 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* REGENXBIO Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title of Class of Securities) 75901B107 (CUSIP Number) December 31, 2020 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate |
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January 8, 2021 |
Financial Statements and Exhibits, Other Events - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 7, 2021 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Num |
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January 8, 2021 |
424B5 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-226691 CALCULATION OF REGISTRATION FEE Title of each class of securities to be registered Amount to be Registered(1) Proposed maximum offering price per unit Proposed maximum aggregate offering price Amount of registration fee(2) Common Stock, par value $0.0001 per share 4,899,000 $47.00 $230,253,000 $25,120.61 (1) Inclu |
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January 8, 2021 |
Exhibit 1.1 EXECUTION VERSION 4,260,000 Shares REGENXBIO INC. COMMON STOCK (PAR VALUE $0.0001 PER SHARE) UNDERWRITING AGREEMENT January 7, 2021 January 7, 2021 BofA Securities, Inc. Morgan Stanley & Co. LLC Barclays Capital Inc. c/o BofA Securities, Inc. One Bryant Park New York, New York 10036 c/o Morgan Stanley & Co. LLC 1585 Broadway New York, New York 10036 c/o Barclays Capital Inc. 745 Sevent |
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January 8, 2021 |
REGENXBIO ANNOUNCES PRICING OF PUBLIC OFFERING OF COMMON STOCK EX-99.1 Exhibit 99.1 REGENXBIO ANNOUNCES PRICING OF PUBLIC OFFERING OF COMMON STOCK ROCKVILLE, Md., January 8, 2021 (PR NEWSWIRE) — REGENXBIO Inc. (Nasdaq:RGNX) today announced the pricing of an underwritten public offering of 4,260,000 shares of its common stock at the price of $47.00 per share before underwriting discounts and commissions. The gross proceeds to REGENXBIO from the offering, befor |
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January 6, 2021 |
Subject to completion, dated January 6, 2021 424B5 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-226691 The information in this preliminary prospectus supplement and the accompanying prospectus is not complete and may be changed. This preliminary prospectus supplement and the accompanying prospectus are not an offer to sell these securities and are not soliciting an offer to buy these securities in any jurisdiction |
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January 5, 2021 |
EX-99.1 Exhibit 99.1 REGENXBIO Announces Update on RGX-314 and Pivotal Program for the Treatment of Wet AMD and New Gene Therapy Program for the Treatment of Duchenne Muscular Dystrophy • Pivotal program for RGX-314, potential best-in-class, one-time gene therapy for the treatment of wet AMD, is active and expected to support BLA filing in 2024 • Recently completed an End of Phase 2 meeting with F |
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January 5, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 5, 2021 REGENXBIO INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Num |
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December 22, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 22, 2020 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File N |
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December 22, 2020 |
EX-99.1 EXHIBIT 99.1 REGENXBIO Announces Agreement to Monetize Portion of Zolgensma® Royalties for $200 Million - Agreement with Healthcare Royalty enables REGENXBIO to advance its broad gene therapy pipeline, including pivotal program for RGX-314 ROCKVILLE, Md., December 22, 2020 (PRNewswire) — REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives |
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November 4, 2020 |
Third Amendment to Lease dated October 30, 2020 between the Registrant and ARE-Maryland No. 24, LLC EXHIBIT 10.4 THIRD AMENDMENT TO LEASE AGREEMENT This THIRD AMENDMENT TO LEASE AGREEMENT (“this Third Amendment”) is dated as of October 30, 2020 (“Effective Date”), by and between ARE-MARYLAND NO. 24, LLC, a Delaware limited liability company, having an address at 26 North Euclid Avenue, Pasadena, California 91101 (“Landlord”), and REGENXBIO INC., a Delaware corporation, having an address at Suite |
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November 4, 2020 |
EXHIBIT 10.2 Certain identified information has been excluded from this exhibit because such information both (i) is not material and (ii) would likely cause competitive harm if publicly disclosed. Excluded information is indicated with brackets and asterisks. UNIVERSITY of PENNSYLVANIA Fifth Amendment to License Agreement This Fifth Amendment to License Agreement (this “Fifth Amendment”) effectiv |
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November 4, 2020 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Numbe |
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November 4, 2020 |
EXHIBIT 10.3 FIFTH AMENDMENT TO LEASE THIS FIFTH AMENDMENT TO LEASE (“this Fifth Amendment”) is made as of this 30th day of October, 2020 (“Effective Date”), between ARE-MARYLAND NO. 45, LLC, a Delaware limited liability company, having an address at 26 North Euclid Avenue, Pasadena, California 91101 (“Landlord”), and REGENXBIO INC., a Delaware corporation, having an address at 9712 Medical Center |
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November 4, 2020 |
Compensation Program for Non-Employee Directors EXHIBIT 10.1 REGENXBIO INC. COMPENSATION PROGRAM FOR NON-EMPLOYEE DIRECTORS (as adopted by the Board of Directors on September 22, 2015 and amended on October 29, 2020) A. Cash Compensation 1. Board retainer: $40,000 per year for each non-employee director, paid in quarterly installments in arrears. 2. Chairman of the Board retainer: $30,000 per year, paid in quarterly installments in arrears. 3. |
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November 4, 2020 |
REGENXBIO Reports Third Quarter 2020 Financial Results and Operational Highlights EXHIBIT 99.1 REGENXBIO Reports Third Quarter 2020 Financial Results and Operational Highlights • RGX-314 subretinal pivotal wet AMD trial expected to initiate in Q1 2021 • Enrollment continues in RGX-314 suprachoroidal Phase II AAVIATE study; initial safety data expected in early 2021 • RGX-314 suprachoroidal Phase II ALTITUDE trial is active and expects to initiate enrollment by end of 2020; init |
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November 4, 2020 |
Financial Statements and Exhibits, Results of Operations and Financial Condition - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 4, 2020 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Nu |
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October 27, 2020 |
Financial Statements and Exhibits, Other Events - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 27, 2020 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Nu |
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October 27, 2020 |
EX-99.1 Exhibit 99.1 REGENXBIO to Receive $80.0 Million Milestone Payment from Novartis AG - Milestone payment based on achievement of $1.0 billion in cumulative net sales of Zolgensma® – - Zolgensma is the first gene therapy based on REGENXBIO’s NAV® Technology Platform approved by the FDA and other regulatory authorities - ROCKVILLE, Md., October 27, 2020 (PRNewswire) — REGENXBIO Inc. (Nasdaq: R |
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September 18, 2020 |
RGNX / REGENXBIO Inc. / Fox Allan M. - SC 13D/A Activist Investment SC 13D/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 1)* REGENXBIO INC. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 75901B107 (CUSIP Number) Allan M. Fox c/o Daniel O’Donnell FOXKISER LLP 1701 Pennsylvania Avenue, NW, Suite 900 Washington, D.C. 20006 (202) |
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August 6, 2020 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001 |
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August 6, 2020 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 6, 2020 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Numb |
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August 6, 2020 |
REGENXBIO Reports Second Quarter 2020 Financial Results and Operational Highlights EXHIBIT 99.1 FOR IMMEDIATE RELEASE REGENXBIO Reports Second Quarter 2020 Financial Results and Operational Highlights • RGX-314 subretinal delivery pivotal program for wet AMD to initiate by end of 2020; positive interim update from Cohorts 4 and 5 at one year in Phase I/IIa trial recently announced • Phase II trial for RGX-314 for wet AMD using suprachoroidal delivery expected to begin enrollment |
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July 2, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 29, 2020 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Numbe |
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June 1, 2020 |
Financial Statements and Exhibits, Submission of Matters to a Vote of Security Holders UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 29, 2020 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Number |
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May 7, 2020 |
REGENXBIO Reports First Quarter 2020 Financial Results and Operational Highlights EXHIBIT 99.1 FOR IMMEDIATE RELEASE REGENXBIO Reports First Quarter 2020 Financial Results and Operational Highlights • Positive long-term and interim data update from RGX-314 Phase I/IIa trial for wet AMD recently announced • RGX-314 clinical trials for treatment of wet AMD and diabetic retinopathy to advance in 2020 using subretinal and suprachoroidal delivery approaches • Additional interim data |
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May 7, 2020 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 00 |
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May 7, 2020 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 7, 2020 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File Number) |
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April 8, 2020 |
RGNX / REGENXBIO Inc. DEFA14A - - DEFA14A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒Filed by a party other than the Registrant ☐ Check the appropriate box: ☐Preliminary Proxy Statement ☐Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e) |
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April 8, 2020 |
definitive proxy statement on Schedule 14A for the 2020 Annual Meeting of Stockholders UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒Filed by a party other than the Registrant ☐ Check the appropriate box: ☐Preliminary Proxy Statement ☐Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e) |
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March 6, 2020 |
RGNX / REGENXBIO Inc. / GIC Private Ltd - SC 13G Passive Investment SC 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* REGENXBIO Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title of Class of Securities) 75901B107 (CUSIP Number) February 27, 2020 (Date of the Event Which Requires Filing of this Statement) Check the appropriate box to designate t |
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February 26, 2020 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37 |
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February 26, 2020 |
EXHIBIT 10.23 Certain identified information has been excluded from this exhibit pursuant to Item 601(b)(10)(iv) of Regulation S-K because such information both (i) is not material and (ii) would likely cause competitive harm if publicly disclosed. Excluded information is indicated with brackets and asterisks. FIRST AMENDMENT TO LICENSE AGREEMENT This First Amendment to License Agreement (the “Fir |
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February 26, 2020 |
EXHIBIT 4.3 Description of Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934 As of December 31, 2019, REGENXBIO Inc. has one class of securities registered under Section 12 of the Securities Exchange Act of 1934, as amended: our common stock, par value $0.0001 per share. The following is a general summary of the terms of shares of our common stock. Th |
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February 26, 2020 |
Compensation Program for Non-Employee Directors EXHIBIT 10.11 REGENXBIO INC. COMPENSATION PROGRAM FOR NON-EMPLOYEE DIRECTORS (as adopted by the Board of Directors on September 22, 2015, amended as of October 29, 2019 and effective as of January 1, 2020) A. Cash Compensation 1. Board retainer: $40,000 per year for each non-employee director, paid in quarterly installments in arrears. 2. Chairman of the Board retainer: $30,000 per year, paid in q |
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February 26, 2020 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 26, 2020 REGENXBIO Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37553 47-1851754 (State or other jurisdiction of incorporation) (Commission File N |
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February 26, 2020 |
Registration Statement on Form S-8 filed on February 26, 2020 As filed with the Securities and Exchange Commission on February 26, 2020 Registration No. |
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February 26, 2020 |
Subsidiaries of the Registrant EXHIBIT 21.1 Subsidiaries of REGENXBIO Inc. Name of Subsidiary Jurisdiction of Incorporation or Organization REGENXBIO EU Limited Ireland |
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February 26, 2020 |
REGENXBIO Reports Fourth Quarter and Full-Year 2019 Financial Results and Operational Highlights EXHIBIT 99.1 FOR IMMEDIATE RELEASE REGENXBIO Reports Fourth Quarter and Full-Year 2019 Financial Results and Operational Highlights • Additional data from RGX-314 Phase I/IIa trial for wet AMD expected in 1H 2020 • RGX-314 clinical trials for treatment of wet AMD and diabetic retinopathy expected to advance in 2020 using subretinal and suprachoroidal delivery approaches • Additional interim data f |
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February 14, 2020 |
Youâve Exceeded the SECâs Traffic Limit Exhibit 99.1 Joint Filing Agreement In accordance with Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the undersigned hereby agree to the joint filing on behalf of each of them of a Statement on Schedule 13G (including any and all amendments thereto, the “Schedule 13G”) relating to the Common Stock, $0.0001 par value per share, of REGENXBIO Inc., which |
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February 14, 2020 |
RGNX / REGENXBIO Inc. / Redmile Group, LLC - SCHEDULE 13G Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. ) REGENXBIO Inc. (Name of Issuer) Common Stock, $0.0001 per share (Title of Class of Securities) 75901B107 (CUSIP Number) December 31, 2019 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to wh |
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February 13, 2020 |
RGNX / REGENXBIO Inc. / Kiser 2012 Gift Trust - SC 13G/A Passive Investment SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 2)* REGENXBIO Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 75901B107 (CUSIP Number) December 31, 2019 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate th |
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February 13, 2020 |
PRVL / Prevail Therapeutics Inc. / REGENXBIO Inc. - SC 13G Passive Investment SC 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Prevail Therapeutics Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 74140Y101 (CUSIP Number) December 31, 2019 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to desi |