Regenxbio

RGNX

Market cap $757M

REGENXBIO Inc. (RGNX) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript

New Phase I/II RGX-202 functional data demonstrates long-term, durable treatment effect at pivotal dose at 18 months  Robust patient enrollment in confirmatory trial continues, expect majority of patients to be dosed by planned BLA filing, mid-year Expecting FDA PDUFA decision and multiple pivotal top-line data readouts in 2026 to support potential commercial launches 2026-2028 In-house manufacturing and strategic global partnerships driving commercial readiness Presentation at 44th Annual J.P. Morgan Healthcare Conference Wednesday, January 14 ROCKVILLE, Md.

ROCKVILLE, Md. , Dec. 18, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will present at the 44th Annual J.P.

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.