Every 8-K that REGENXBIO Inc. (RGNX) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow RGNX and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full RGNX filings page.
On September 23, 2026, REGENXBIO Inc. entered into a settlement agreement with The Trustees of the University of Pennsylvania, Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., concerning patent litigation related to Sarepta’s SRP-9001, also known as ELEVIDYS in the U.S. Sarepta will pay REGENXBIO $39.0 million within 10 days of the agreement’s effective date. Thereafter, the parties will terminate with prejudice all ongoing patent litigation regarding the patents in suit.
REGENXBIO and UPenn agreed to release current claims and not pursue specified future claims relating to Sarepta gene therapy products using an AAVrh74-based capsid, including ELEVIDYS. REGENXBIO also agreed not to sue over its patents covering ELEVIDYS in its existing form or the capsid sequence; that commitment does not extend to patents covering other aspects of gene therapy products.
REGENXBIO Inc. (RGNX) reported board and leadership changes along with related director compensation. The board elected Gregory (Greg) Ciongoli as an independent Class II director effective August 25, 2026, with his term running until the 2029 annual meeting. He was also appointed to the Audit Committee and the Nominating and Corporate Governance Committee.
Under the non-employee director compensation program, Mr. Ciongoli received an initial equity award with a grant date fair value of $550,000, split 75% into stock options and 25% into RSUs, with an exercise price of $8.91 per share and three-year vesting schedules, including full acceleration upon a change of control or death. He will receive a $45,000 annual board retainer plus $10,000 and $5,000 retainers for Audit and Nominating and Corporate Governance Committee service, respectively, and will be eligible for future annual equity awards.
The board accepted the resignations of directors Jean Bennett, M.D., Ph.D. and A.N. “Jerry” Karabelas, Ph.D., effective August 25, 2026. Both will serve as advisors to the company through February 2027, and the board size was reduced to nine directors.
REGENXBIO Inc. (RGNX) reported a significant regulatory setback for its RGX-121 gene therapy program for Mucopolysaccharidosis type II (Hunter Syndrome). The FDA has placed the Investigational New Drug application for the Phase I/II/III trial of RGX-121 on a clinical hold, and the company does not expect to resubmit the RGX-121 Biologics License Application in the near term.
The hold follows discovery of asymptomatic spine MRI findings (small nodules or cystic masses) in five CAMPSIITE® study participants dosed approximately three to six years ago. Investigators deemed these findings nonserious and radiologists believe they are likely benign, with patients showing stability to improvement on neurocognitive and neurobehavioral assessments. REGENXBIO states it remains focused on other late-stage programs, including RGX-202 for Duchenne muscular dystrophy and ABBV‑RGX‑314 for wet AMD and diabetic retinopathy, with upcoming regulatory and data milestones described as on track.
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. 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. reported that it earned a $100 million milestone payment from AbbVie after dosing the first patient in the Phase IIb/III NAAVIGATE trial of investigational gene therapy surabgene lomparvovec (sura-vec, ABBV-RGX-314) for diabetic retinopathy using suprachoroidal delivery. The payment is tied to REGENXBIO’s 2021 collaboration and license agreement with AbbVie and is expected to be received in July 2026. NAAVIGATE will evaluate a one-time gene therapy dose of 1.0x1012 genome copies per eye in approximately 135 U.S. participants with non-proliferative diabetic retinopathy, with a primary endpoint of more than a two-step improvement on the diabetic retinopathy severity scale at one year. REGENXBIO also plans to present long-term data from its ALTITUDE and wet AMD studies and to announce topline pivotal trial data for sura-vec in wet AMD with AbbVie in Q4 2026.
REGENXBIO Inc. reported the results of its 2026 annual stockholder meeting and launched a stock option exchange program for non-executive employees. Stockholders elected three Class II directors to serve until the 2029 annual meeting and ratified PricewaterhouseCoopers LLP as independent auditor for the year ending December 31, 2026.
Stockholders also approved, on an advisory basis, the compensation of named executive officers and approved a Stock Option Exchange Program for non-executive employees, but did not approve a similar program for executive employees. On June 3, 2026, the company began the approved exchange program, allowing eligible non-executive employees to exchange underwater options with exercise prices at or above $18.00 for a reduced number of options with an exercise price set at fair market value after the offer period, which runs from June 3 to July 1, 2026. The company states the program is not expected to significantly change its stock compensation expense.
REGENXBIO Inc. reported a sharp swing to a first quarter 2026 net loss while unveiling strong pivotal data for its Duchenne gene therapy RGX-202. Revenue fell to $6.4 million from $89.0 million a year earlier, mainly because prior-period Nippon Shinyaku license revenue and ZOLGENSMA royalties rolled off. The company posted a net loss of $90.1 million, or $1.72 per share, versus net income of $6.1 million last year.
Cash, cash equivalents and marketable securities were $150.5 million as of March 31, 2026, and management expects this to fund operations into early 2027. On the pipeline, the pivotal Phase III AFFINITY DUCHENNE trial met its primary endpoint, with 93% of RGX-202 patients achieving more than 10% microdystrophin expression and a statistically significant correlation with functional improvement, supporting plans to pursue accelerated approval and a potential 2027 commercial launch. The company also highlighted a lifted clinical hold on RGX-121 and expects a $100 million milestone from AbbVie when the first patient is dosed in the NAAVIGATE diabetic retinopathy study in Q2 2026.
REGENXBIO Inc. entered into a Settlement and Release Agreement with GlaxoSmithKline LLC to resolve a dispute related to their 2009 license sublicensing arrangement. Under the agreement, REGENXBIO will pay $10.0 million to GSK within three business days of the agreement’s effective date for alleged underpayment of sublicense fees on amounts received from sublicensees, including royalties. The parties are granting each other mutual releases for all past claims connected to the sublicense and certain specified future claims, while REGENXBIO will continue paying GSK under existing sublicense agreements using its current allocation methodology.
REGENXBIO Inc. reported strong revenue growth but continued losses for the quarter and year ended December 31, 2025. Full-year revenue rose to $170.4 million from $83.3 million, mainly from its Nippon Shinyaku collaboration and higher Zolgensma and Itvisma royalties. Net loss narrowed to $193.9 million, or $3.76 per share, from $227.1 million, or $4.59 per share. Cash, cash equivalents and marketable securities totaled $240.9 million, and the company expects this to fund operations into early 2027.
Late-stage gene therapy programs advanced, led by RGX-202 for Duchenne muscular dystrophy with positive 18‑month functional data and pivotal topline results expected in early Q2 2026. Sura-vec (ABBV‑RGX‑314) for retinal diseases is moving toward pivotal readouts and a potential $100 million AbbVie milestone upon first patient dosing in the NAAVIGATE trial expected in Q2 2026. However, the FDA placed clinical holds on RGX‑111 and RGX‑121 and issued a complete response letter for the RGX‑121 BLA, which the company is working to address.
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. 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. (RGNX) furnished quarterly results. The company submitted an 8‑K announcing it issued a press release covering results of operations and financial condition for the quarter ended September 30, 2025. The press release is included as Exhibit 99.1 and incorporated by reference therein.
The information under Item 2.02 and Exhibit 99.1 is furnished, not filed, under the Exchange Act. REGENXBIO’s common stock trades on the Nasdaq Global Select Market under the symbol RGNX.
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.