Regenxbio

RGNX

Market cap $638M

ROCKVILLE, Md. , Nov. 25, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in the following investor conference: Piper Sandler 37th Annual Healthcare Conference Fireside Chat: Tuesday, December 2 at 8:30 a.m.

REGENXBIO Inc. ( RGNX ) Q3 2025 Earnings Call November 6, 2025 8:00 AM EST Company Participants Patrick Christmas - Executive VP & Chief Strategy and Legal Officer Curran Simpson - President, CEO & Director Steve Pakola - Executive VP & Chief Medical Officer Mitchell Chan - Executive VP & CFO Conference Call Participants Judah Frommer - Morgan Stanley, Research Division Lili Nsongo - Leerink Partners LLC, Research Division Huidong Wang - Barclays Bank PLC, Research Division Luca Issi - RBC Capital Markets, Research Division Annabel Samimy - Stifel, Nicolaus & Company, Incorporated, Research Division Alec Stranahan - BofA Securities, Research Division Brian Skorney - Robert W. Baird & Co. Incorporated, Research Division Sean McCutcheon - CGS International Daniil Gataulin - Chardan Capital Markets, LLC, Research Division Bill Man Yi Chen - H.C.

Regenxbio (RGNX) came out with a quarterly loss of $1.2 per share versus the Zacks Consensus Estimate of a loss of $1.38. This compares to a loss of $1.17 per share a year ago.

RGX-202 program for Duchenne muscular dystrophy advancing rapidly, topline results expected early Q2 2026 and BLA submission mid-2026 Pivotal trial enrollment completed in October; confirmatory trial open and enrolling  New 12-month analysis shows all participants demonstrate improved functional outcomes across multiple natural history methods of measurement, when decline is expected Clemidsogene lanparvovec (RGX-121) on track to be first gene therapy and one-time treatment for MPS II; PDUFA date February 8, 2026 Surabgene lomparvovec (sura-vec, ABBV-RGX-314) on track to be first gene therapy for chronic retinal disease Enrollment completed in pivotal trials evaluating subretinal delivery of sura-vec in wet AMD; topline data expected Q4 2026 Sura-vec for diabetic retinopathy using suprachoroidal delivery advancing to global pivotal program, supported by positive 2-year Phase II trial data Conference call today at 8:00 a.m. ET ROCKVILLE, Md.

Patients treated with RGX-202 demonstrate consistent, robust microdystrophin expression and functional improvement compared to natural history in Phase I/II portion of AFFINITY DUCHENNE® trial supporting potential approval via the accelerated approval pathway REGENXBIO continues to enroll patients in the confirmatory trial First batches intended for commercial supply manufactured at in-house Manufacturing Innovation Center Capacity to produce up to 2,500 RGX-202 doses per year Topline pivotal data now expected in early Q2 2026 and BLA submission in mid-2026 ROCKVILLE, Md. , Oct. 30, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the completion of enrollment in the AFFINITY DUCHENNE® pivotal trial of RGX-202, an investigational gene therapy for the treatment of Duchenne muscular dystrophy, as well as the successful production of the first batches intended for commercial supply.

ROCKVILLE, Md. , Oct. 29, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Thursday, November 6, at 8:00 a.m.

ROCKVILLE, Md. , Oct. 15, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in the following investor conferences: Chardan's 9th Annual Genetic Medicines Conference Panel "Battleground States for Muscular Dystrophies": Tuesday, October 21 at 2:00 p.m.

ROCKVILLE, Md. , Oct. 9, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will present interim data from the Phase II ALTITUDE® trial evaluating suprachoroidal delivery of surabgene lomparvovec (ABBV-RGX-314, sura-vec) for the treatment of diabetic retinopathy (DR) at the American Academy of Ophthalmology 2025 Annual Meeting.

Over 1,200 participants enrolled in ATMOSPHERE® and ASCENT® pivotal trials, representing largest global gene therapy program ever conducted Subretinal surabgene lomparvovec on track to be first gene therapy for wet AMD Topline pivotal data expected in Q4 2026 ROCKVILLE, Md. , Oct. 6, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the completion of enrollment in the ATMOSPHERE® and ASCENT® pivotal studies evaluating surabgene lomparvovec (sura-vec, ABBV-RGX-314) in wet age-related macular degeneration (wet AMD) using subretinal delivery.

ROCKVILLE, Md. , Sept. 29, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced Chief Medical Officer, Steve Pakola, M.D.