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 second-quarter 2026 results with total revenues of $108.0 million, up from $21.4 million a year earlier, largely driven by a $100.0 million milestone payment from AbbVie tied to the Phase IIb/III NAAVIGATE diabetic retinopathy study. The company generated net income of $22.7 million, or $0.43 per share, compared with a $70.9 million net loss in Q2 2025. R&D expenses were $56.1 million and G&A expenses were $21.6 million. Cash, cash equivalents and marketable securities were $105.5 million at June 30, 2026; including July milestone and equity offering proceeds, pro forma cash was approximately $313 million, which the company expects will fund operations into Q4 2027.
Clinically, the Phase III AFFINITY DUCHENNE trial of RGX-202 for Duchenne muscular dystrophy met its primary endpoint with high statistical significance, with RGX-202 well-tolerated and commercial supply being produced in-house. The company plans to initiate a RGX-202 BLA submission in Q3 2026 under the accelerated approval pathway, with potential approval in 2H 2027 and an ex-U.S. AFFINITY RISE trial starting in 1H 2027. In retinal disease, long-term data for sura-vec (ABBV-RGX-314) support durable safety and efficacy, with pivotal wet AMD readouts from ATMOSPHERE and ASCENT expected in Q4 2026 and the NAAVIGATE Phase IIb/III DR study underway. For NAVSUNLI (RGX-121) in Hunter syndrome, a positive FDA Type A meeting confirmed no additional studies are required for BLA resubmission, which is planned for Q3 2026.
REGENXBIO Inc. Chief Medical Officer Steve Pakola reported a tax-withholding disposition of 7,468 shares of common stock on August 1, 2026, at $9.69 per share. The shares were withheld to cover taxes on vesting restricted stock units granted August 1, 2024. He now directly holds 205,541 shares.
REGENXBIO Inc. executive Patrick J. Christmas, Chief Strategy & Legal Officer, reported a tax-withholding disposition of 4,699 shares of common stock on August 1, 2026 at $9.69 per share. The shares were withheld to cover taxes on vesting RSUs granted August 1, 2024, leaving him with 205,968 shares held directly. The transaction was not made under a Rule 10b5-1 trading plan.
REGENXBIO Inc. entered into an underwriting agreement for an underwritten public offering of 10,003,889 shares of common stock at $9.00 per share and 1,111,111 pre-funded warrants at $8.9999 per warrant, under its effective Form S-3 shelf registration.
The company granted underwriters a 30-day option to buy up to 1,667,250 additional shares, which was exercised in full, and expects net proceeds of approximately $107.8 million after underwriting discounts, commissions and expenses. The pre-funded warrants have a $0.0001 per-share exercise price, are exercisable at any time, do not expire, and confer no stockholder rights until exercised. The offering is expected to close on July 20, 2026, subject to customary conditions.
REGENXBIO Inc. is raising capital through a primary offering of equity and pre-funded warrants under its Form S-3 shelf. The company is offering 10,003,889 shares of common stock and 1,111,111 pre-funded warrants to purchase common stock at a public offering price of $9.00 per share and $8.9999 per warrant, for an aggregate public offering price of $100,034,889. Underwriters have a 30-day option to buy up to 1,667,250 additional shares.
After $6,002,100 in underwriting discounts and estimated expenses, net proceeds are expected to be about $93.7 million, or $107.8 million if the option is fully exercised. As of March 31, 2026, net tangible book value was $0.41 per share; giving effect to the offering (excluding warrant exercise), this would increase to $1.86 per share, implying dilution of $7.14 per share to new investors. Pre-funded warrants have a $0.0001 exercise price, no expiration, and include 4.99%/9.99% beneficial ownership limits and cashless exercise features.
The company reports preliminary cash, cash equivalents and marketable securities of approximately $105.5 million at June 30, 2026, down from $150.5 million at March 31, 2026, and expects a $100.0 million milestone payment from AbbVie in July 2026. Based on its current plan and excluding this offering, it believes these resources and the AbbVie milestone are sufficient to fund operations into the second quarter of 2027, but its financial statements include a going concern explanatory paragraph. Proceeds are intended for general corporate purposes including clinical trials, pipeline development and potential commercialization of gene therapy candidates such as RGX-202 for Duchenne muscular dystrophy, for which a BLA filing via the accelerated approval pathway is anticipated in the third quarter of 2026.
REGENXBIO Inc. plans a primary offering of $100,000,000 of common stock under its shelf registration, with a 30‑day option for underwriters to purchase additional shares. Net proceeds are intended for general corporate purposes, including clinical trials, pipeline development, working capital, and potential debt repayment or acquisitions.
REGENXBIO is a clinical‑stage gene therapy company. Lead candidate RGX‑202 for Duchenne muscular dystrophy has a fully enrolled pivotal Phase III cohort (n=30) with positive topline data, and a biologics license application is targeted for the third quarter of 2026 using the FDA’s accelerated approval pathway.
The company expects cash, cash equivalents and marketable securities of approximately $105.5 million as of June 30, 2026, versus $150.5 million on March 31, 2026, and anticipates a $100.0 million AbbVie milestone in July 2026. It believes these resources will fund operations into the second quarter of 2027, while recent financial statements and risk disclosures state substantial doubt about the ability to continue as a going concern.
REGENXBIO Inc. Chief Executive Officer Simpson Curran reported routine equity compensation activity in company stock. On December 31, 2025, Curran acquired 951 shares of common stock at $6.9955 per share through the Employee Stock Purchase Plan (ESPP) for the July 1–December 31, 2025 purchase period, exempt under Rule 16b-3(c).
On June 30, 2026, Curran acquired an additional 1,453 shares at $10.18 per share via the ESPP for the January 1–June 30, 2026 purchase period. In line with the ESPP, these shares were bought at 85% of the relevant closing prices. On July 1, 2026, 6,818 shares were withheld at $13.09 per share to cover taxes upon vesting of restricted stock units granted on July 1, 2024, a non-market, tax-withholding disposition. After these transactions, Curran directly owned 338,053 shares of REGENXBIO common stock.
REGENXBIO Inc. Chief Medical Officer Steve Pakola exercised stock options and sold shares in a planned transaction. On this Form 4, he exercised options for 2,161 shares of common stock at $7.86 per share, then sold 2,161 shares in an open-market sale at $13.64 per share.
These transactions were made pursuant to a Rule 10b5-1 trading plan, indicating they were pre-scheduled. After the sale, he directly holds 213,009 shares of common stock and 64,812 stock options that remain exercisable.
REGENXBIO filed Amendment No. 2 to its Schedule TO reporting final results of an employee Exchange Offer to swap eligible outstanding options for replacement options. The Offer expired July 1, 2026; 184 eligible holders tendered options.
The Company accepted Eligible Options to purchase 1,940,394 shares (≈67.0% of shares underlying Eligible Options). All tendered options were cancelled effective July 2, 2026, and the Company granted Replacement Options to purchase 775,401 shares with an exercise price of $13.28 per share (closing Nasdaq price on July 2, 2026), under the 2025 Equity Incentive Plan.
REGENXBIO Inc. Chief Medical Officer Steve Pakola reported exercising stock options for 36,725 shares of common stock at $7.8600 per share on July 1, 2026, then selling 36,725 shares at $12.8600 the same day and 19,608 shares at $11.0400 on June 29, 2026.
After these trades he directly holds 213,009 shares of common stock, and 66,973 stock options from the reported award remained outstanding. Footnotes state that at least one transaction was effected under a Rule 10b5-1 trading plan, that some sales were executed in multiple trades at weighted-average prices between $11.00 and $11.18, and that a previously granted option for 103,698 shares vests 25% on January 2, 2026 with the balance in equal monthly installments over 36 months while he continues in service.