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.
REGENXBIO Inc. reported that the U.S. FDA issued a Complete Response Letter for its Biologics License Application for RGX-121, an investigational one-time gene therapy for Mucopolysaccharidosis II (Hunter syndrome). The FDA cited concerns about defining the neuronopathic patient population, the suitability of the natural history external control, and using CSF HS D2S6 as a surrogate endpoint.
The letter outlines potential paths forward, such as a new study, treating additional patients with longer-term follow-up, or using an untreated control arm, which the company notes are challenging in this ultra-rare disease. REGENXBIO plans to request a Type A meeting and aims to resubmit the BLA after providing additional data and expert input.
REGENXBIO Inc. Chief Strategy & Legal Officer Patrick J. Christmas reported a routine tax-related share withholding. On February 1, 2026, 4,700 shares of common stock were withheld at $11.16 per share to cover taxes on vesting restricted stock units. After this transaction, he beneficially owned 210,667 shares of REGENXBIO common stock directly.
REGENXBIO Inc. Chief Medical Officer reports tax share withholding. On February 1, 2026, 5,267 shares of REGENXBIO common stock were withheld at $11.16 per share to cover taxes due on the vesting of restricted stock units originally granted on August 1, 2024.
After this transaction, the reporting officer directly beneficially owned 253,050 shares of REGENXBIO common stock. The transaction was coded "F," indicating a tax-related withholding tied to equity compensation rather than an open-market trade.
REGENXBIO Inc. director Kenneth T. Mills reported exercising stock options for 225,000 shares of common stock on January 27, 2026 at an exercise price of $13.09 per share. These options were originally granted in 2016 and had fully vested prior to exercise.
To cover the option exercise price and related taxes, 221,753 shares of common stock were withheld by the company at a reference price of $13.41 per share, and the filing states there was no open-market sale involved. After these transactions, Mills directly beneficially owned 486,118 shares of REGENXBIO common stock.
REGENXBIO Inc. reported that the U.S. Food and Drug Administration has placed clinical holds on two of its gene therapy programs. On January 28, 2026, the FDA put the Company’s Investigational New Drug applications for the Phase I/II trial of RGX-111 for Mucopolysaccharidosis type I and the Phase I/II/III trial of RGX-121 for Mucopolysaccharidosis type II on clinical hold. The Company disclosed this development and filed the related press release as an exhibit.
REGENXBIO Inc. received an updated ownership report from BlackRock Portfolio Management LLC, which filed Amendment No. 1 to its Schedule 13G. BlackRock reports beneficial ownership of 2,085,619 shares of REGENXBIO common stock, representing 4.1% of the outstanding shares as of the stated event date. BlackRock has sole voting power over 1,818,311 shares and sole dispositive power over the full 2,085,619 shares, with no shared voting or dispositive power.
The filing explains that these holdings reflect securities beneficially owned, or deemed to be beneficially owned, by certain business units of BlackRock, Inc. and its affiliates. Various underlying clients have the right to receive dividends or sale proceeds, but no single client holds more than five percent of REGENXBIO’s outstanding common stock. BlackRock certifies that the securities were acquired and are held in the ordinary course of business and not for the purpose of changing or influencing control of REGENXBIO.
REGENXBIO Inc. Chief Medical Officer Steve Pakola reported equity awards in the form of restricted stock units and stock options. On January 6, 2026, he received 65,847 shares of common stock underlying a time-based RSU grant at $0.00 per share, with 25% scheduled to vest on each of January 6, 2027, 2028, 2029 and 2030, contingent on continued service. He was also granted 35,402 stock options with a $14.18 exercise price, expiring on January 6, 2036; 25% of these options vest after 12 months of continuous service, and the remainder vest in equal monthly installments over the following 36 months starting after January 6, 2027. Following these grants, he directly beneficially owns 258,317 shares of common stock and 35,402 stock options.
REGENXBIO Inc. Chief Technology Officer Craig Malzahn reported new equity awards. On January 6, 2026, he was granted 65,847 shares of common stock for $0.00 per share, representing a restricted stock unit award. According to the terms, 25% of these RSUs will vest on each of January 6, 2027, January 6, 2028, January 6, 2029 and January 6, 2030, as long as he continues to provide service to the company.
After this grant, he beneficially owned 82,194 shares of common stock directly. He also received stock options to purchase 35,402 shares of common stock at an exercise price of $14.18 per share, expiring January 6, 2036. For this option, 25% of the shares will vest after 12 months of continuous service, with the remaining shares vesting in equal monthly installments over the 36 months following January 6, 2027.
REGENXBIO Inc. reported that Chief Executive Officer and director Simpson Curran received new equity awards on January 6, 2026. The filing shows a grant of 144,864 shares of common stock underlying a time-based restricted stock unit award at $0.00 per share, with 25% of the shares vesting on each of January 6, 2027, January 6, 2028, January 6, 2029, and January 6, 2030 while continuous service is maintained. After this grant, Curran directly beneficially owned 342,467 shares of common stock. The filing also reports an option grant for 233,651 stock options with an exercise price of $14.18 per share, expiring on January 6, 2036. Twenty‑five percent of these options vest after 12 months of continuous service with the remaining balance vesting in equal monthly installments over the 36 months following January 6, 2027.
REGENXBIO Inc.'s Chief Strategy & Legal Officer, Patrick J. Christmas, reported new equity awards. On January 6, 2026, he received 73,749 shares of common stock through a time-based restricted stock unit award at a price of $0.00 per share. According to the award terms, 25% of these RSUs will vest on each of January 6, 2027, 2028, 2029 and 2030, as long as he continues providing service to the company.
He was also granted stock options for 39,650 shares of common stock with an exercise price of $14.18 per share. These options vest 25% after 12 months of continuous service, with the remaining balance vesting in equal monthly installments over the 36 months following January 6, 2027, subject to continued service, and expire on January 6, 2036. After these transactions, he directly holds 215,367 shares of common stock and 39,650 stock options.