REGENXBIO Inc. filings document governance, operating results and material events for a biotechnology company developing AAV gene therapies. Recent 8-K disclosures include quarterly and annual results, FDA communications involving RGX-121 and RGX-111, and regulatory updates tied to a Biologics License Application and investigational new drug applications.
The filing record also covers collaboration and license matters, including an amendment to the AbbVie collaboration for surabgene lomparvovec and a settlement related to the GSK-REGENXBIO sublicense. Proxy materials describe board elections, stockholder meeting matters, executive compensation, equity awards and other governance disclosures for the Delaware corporation.
Chan Mitchell, the Chief Financial Officer of REGENXBIO Inc. (RGNX), reported a non-derivative disposition on 09/01/2025. The filing shows 4,901 shares of common stock were withheld to satisfy taxes upon the vesting of restricted stock units originally granted on September 16, 2024, using a withholding price of $8.93 (based on the closing price on August 29, 2025). After the withholding, the reporting person beneficially owns 53,968 shares directly. The Form 4 was signed by an attorney-in-fact on behalf of the reporting person on 09/03/2025.
REGENXBIO Inc. reported that the U.S. Food and Drug Administration has extended the review timeline for its biologics license application seeking accelerated approval of clemidsogene lanparvovec (RGX-121), a treatment for Mucopolysaccharidosis II (Hunter syndrome). The FDA moved the Prescription Drug User Fee Act (PDUFA) action date from November 9, 2025 to February 8, 2026 to allow additional time to review new data submitted for the application.
Redmile Group, LLC and related persons report a 9.99% beneficial position in REGENXBIO Inc. The filing shows Redmile Group, LLC and principal Jeremy C. Green each report shared voting and dispositive power over 5,062,477 shares, representing 9.9% of the class on a calculated basis. Those totals include 286,760 shares that could be issued upon exercise of pre-funded warrants but are limited by a Beneficial Ownership Limitation that prevents exercise that would cause ownership to exceed 9.99%. Redmile Biopharma Investments III, L.P. reports ownership of 3,733,796 shares (7.4%), comprised of 3,447,036 directly held shares plus warrants subject to the same blocker. All parties disclaim ownership except for pecuniary interest. The percentage base uses 50,388,693 outstanding shares as of June 9, 2025, plus the 286,760 potentially issuable Warrant shares.
REGENXBIO Inc. (RGNX) – Form 4 Insider Transaction
Chief Executive Officer and Director Curran Simpson reported a Code F transaction on 07/01/2025 involving 4,701 shares of RGNX common stock. Code F indicates shares were withheld by the company to satisfy tax obligations upon the vesting of previously granted restricted stock units (RSUs) dated 07/01/2024. The shares were valued at $8.23, the closing price on the vesting date.
Following the withholding, Simpson’s direct beneficial ownership stands at 252,331 common shares. No open-market purchase or sale occurred, and no derivative securities were exercised or disposed of.
- Transaction type: tax-related share withholding (non-cash).
- Remaining ownership suggests continued alignment with shareholders.
- No new options, warrants, or other derivatives reported.
The filing is routine and carries limited market impact, primarily confirming the executive’s updated share count.
The SEC has declared REGENXBIO's Form S-3 registration statement effective as of June 25, 2025 at 4:00 P.M. The registration statement was filed under file number 333-288053.
Form S-3 is a simplified security registration form used by companies that have already met certain reporting requirements. This effectiveness notice indicates that REGENXBIO can now proceed with their planned securities offering as outlined in the registration statement.
This is a significant development for REGENXBIO (NASDAQ: RGNX) as it provides them with the ability to:
- Access the public markets for capital raising
- Issue various types of securities as described in their registration statement
- Execute their financing strategy through shelf offerings
REGENXBIO has filed a prospectus for the potential resale of up to 268,096 shares of common stock by a selling stockholder. These shares are issuable through a warrant with an exercise price of $14.92 per share, connected to a May 2025 Loan Agreement with HealthCare Royalty Management.
Key financial points:
- Potential proceeds of $4.0 million if warrant is fully exercised
- Current stock price: $8.56 (as of June 24, 2025)
- Trading symbol: RGNX on Nasdaq Global Select Market
REGENXBIO is a clinical-stage biotechnology company focused on gene therapy using their proprietary NAV® Technology Platform. Their platform utilizes AAV vectors for gene delivery, including AAV8 and AAV9. The company has multiple ongoing clinical trials including AAVIATE®, AFFINITY BEYOND®, ALTITUDE®, and ATMOSPHERE®. Key partnerships include collaborations with AbbVie for ABBV-RGX-314 and Nippon Shinyaku for RGX-121 and RGX-111 development.