Regenxbio, Solid report data with Duchenne gene therapies. This week saw both Regenxbio and Solid Bio report new data with their gene therapy candidates for Duchenne muscular dystrophy (DMD), vying to join Sarepta's Elevidys on the market. Regenxbio gave an update on the phase 2/3 AFFINITY DUCHENNE trial of its RGX-202, reporting interim results that showed it was well tolerated, achieved robust expression of microdystrophin to replace the mutated dystrophin protein in DMD, and led to early functional improvements in ambulatory DMD patients aged one and over. The data, from seven subjects in the study treated with the target dose of RGX-202, showed that their motor function 12 months later - measured using the North Star Ambulatory Assessment (NSAA) scale and timed function tests - was improved compared to matched external natural history comparisons and predictive modelling. The results also showed that patients demonstrated cardiac stability at one year post-treatment as measured by MRI endpoints, an important finding as DMD causes progressive cardiac muscle degeneration (cardiomyopathy). The company is now expecting to report pivotal data from the study in the second quarter of this year, and said it will ask for a meeting with the FDA to look at possible pathways toward filing RGX-202 for accelerated approval while it runs an ongoing confirmatory study. Solid Bio, meanwhile, reported this week that its SGT-003 candidate had also achieved strong expression of microdystrophin, along with improvements in muscle integrity, including stabilisation and improvement in cardiac function in its phase 1/2 INSPIRE DUCHENNE trial. For now, the investigators remain blinded to the motor function data in the study, which has now enrolled 40 subjects. Solid Bio said it is hoping to schedule meetings with the FDA in the first half of this year to seek guidance on accelerated approval, and indicated that it already has an agreement with the agency on the design of a phase 3 trial that will be called IMPACT DUCHENNE and is due to start dosing patients before the end of this month. Both companies are hoping to provide an alternative one-shot treatment to Elevidys, which was launched in 2023, but ran into trouble last year after three fatalities were reported in non-ambulatory DMD recipients, leading to a pause in distribution. The fatalities, linked to liver toxicity, eventually resulted in Elevidys' label being restricted to ambulatory patients only, but did not stop the product knocking on the door of blockbuster status last year, with sales of $899 million. Regenxbio and Solid Bio have both pointed to the safety profile of their gene therapies, saying there was no evidence of liver injury in their trial updates. The two studies were presented at the 2026 Muscular Dystrophy Association (MDA) annual meeting earlier this week. 13 March, 2026

Gainey McKenna & Egleston announces A class action lawsuit has been filed against REGENXBIO Inc. (RGNX). NEW YORK, Feb. 16, 2026 (GLOBE NEWSWIRE) - Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the District of Maryland on behalf of all persons or entities who purchased or otherwise acquired REGENXBIO Inc. ("REGENXBIO" or the "Company") (NASDAQ: RGNX) securities between February 9, 2022 and January 27, 2026, inclusive (the "Class Period"). The Complaint alleges that Defendants provided overwhelmingly positive statements to investors while, at the same time, disseminating false and misleading statements and/or concealing material adverse facts concerning the efficacy and safety of its RGX-111 trial study. The Complaint further alleges that the truth began to emerge on January 28, 2026, when REGENXBIO issued a press release announcing that the FDA placed a clinical hold on its investigational gene therapy RGX-111. The Complaint alleges that Defendants announced that an intraventricular CNS tumor was found in a participant treated in its RGX-111 Phase I/II study. The Complaint continues to allege that investors and analysts reacted immediately to REGENXBIO's revelation. The price of the Company's common stock declined from a closing market price of $13.41 per share on January 27, 2026; the Company's stock price fell to $11.01 per share on January 28, 2026, a decline of 17.8% in the span of just a single day. Investors who purchased or otherwise acquired shares of REGENXBIO should contact the Firm prior to the April 14, 2026 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at [email protected] or [email protected]. Please visit our website at http://www.gme-law.com for more information about the firm. Company Profile Gainey McKenna & Egleston Industry: Consumer Services Recommended reading. Explore. February 16, 2026 11:00 ET February 16, 2026 11:07 ET February 16, 2026 11:01 ET February 16, 2026 11:00 ET February 16, 2026 11:07 ET February 16, 2026 11:01 ET February 16, 2026 11:00 ET

REGENXBIO announces Pivotal Program for Surabgene Lomparvovec in Diabetic Retinopathy.