Welcome to our dedicated page for Regenxbio SEC filings (Ticker: RGNX), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The REGENXBIO Inc. (RGNX) SEC filings page brings together the company’s regulatory disclosures filed with the U.S. Securities and Exchange Commission. As a Nasdaq-listed biotechnology issuer focused on AAV gene therapy, REGENXBIO uses current reports on Form 8-K and other filings to communicate material information about its operations, clinical programs, collaborations and financial condition.
Recent 8-K filings illustrate how the company reports key developments. One Form 8-K describes the issuance of a press release covering financial results and operational highlights for the quarter ended September 30, 2025, including updates on late-stage programs such as RGX-202 for Duchenne muscular dystrophy, clemidsogene lanparvovec (RGX-121) for MPS II and surabgene lomparvovec (ABBV-RGX-314, sura-vec) for retinal disease. Another 8-K details the FDA’s extension of the Prescription Drug User Fee Act (PDUFA) action date for the RGX-121 Biologics License Application for MPS II, moving the date to February 8, 2026 to allow review of additional data.
REGENXBIO also uses Form 8-K to disclose significant collaboration changes. An 8-K filed in August 2025 outlines a first amendment to the collaboration and license agreement with AbbVie, which modifies the development plan and milestone structure for the diabetic retinopathy program using suprachoroidal delivery and adds further AbbVie-led investment in the subretinal wet AMD program. The filing explains new milestone payment terms tied to first patient dosing in registration-enabling trials and references a joint press release attached as an exhibit.
On this page, investors can review such 8-Ks alongside other SEC documents to understand how REGENXBIO reports clinical milestones, regulatory interactions, collaboration amendments and financial results. Stock Titan’s tools can help surface the most recent filings, while AI-powered summaries can clarify the main points of lengthy documents, highlight items such as PDUFA date changes or collaboration amendments, and make it easier to follow how these disclosures relate to the company’s gene therapy pipeline and RGNX stock.
REGENXBIO Inc. is registering up to $150 million of common stock for an at-the-market offering through Leerink Partners, which will act as sales agent for a fee of up to 3.0% of gross proceeds. Shares may be sold from time to time on Nasdaq under the symbol RGNX or in other permitted transactions.
The company estimates it held about $241 million of cash, cash equivalents and marketable securities as of December 31, 2025 and currently expects this to fund operations into early 2027. Despite this, REGENXBIO states that there is substantial doubt about its ability to continue as a going concern within 12 months of filing its 2025 Form 10‑K and anticipates an auditor opinion including a going‑concern explanatory paragraph.
Regulatory setbacks add to the risk profile. The FDA issued a Complete Response Letter for RGX‑121, outlining several scientific concerns, and placed clinical holds on RGX‑111 and RGX‑121 after a neoplasm was observed in one RGX‑111 trial participant. The company warns these issues, along with potential dilution—illustrated by a scenario where 17,647,058 shares are sold at $8.50 per share—could materially affect its business and stock price.
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.