REGENXBIO, Inc. Stock News

REGENXBIO specializes in gene therapies using proven AAV technology. RGX-121, targets Hunter syndrome and is under FDA review, with a PDUFA date set for November 9, 2025. We believe the upcoming FDA decision represents a significant catalyst for RGNX shares, offering a compelling pre-approval investment opportunity.

RGX-202 demonstrating consistent evidence of positively changing disease trajectory for Duchenne All dose level 2 participants exceeded external natural history controls on all functional measures Biomarker data demonstrate consistent, robust microdystrophin expression and transduction levels across all treated ages One new participant aged 2 years at dosing had expression level at 118.6% compa...

Event will feature Aravindhan Veerapandiyan, M.D., principal investigator of the AFFINITY DUCHENNE® trial ROCKVILLE, Md.

$150 million secured at closing extends cash runway into early 2027 REGENXBIO retains additional potential non-dilutive funding opportunities, including monetization of Priority Review Voucher (PRV) and milestones from AbbVie ROCKVILLE, Md. , May 19, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the closure of a non-dilutive, limited recourse royalty bond agreement of up to...

PARAMUS, N.J. , May 14, 2025 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd.

REGENXBIO Inc. (NASDAQ:RGNX ) Q1 2025 Earnings Conference Call May 12, 2025 4:30 PM ET Company Participants Patrick Christmas - Chief Legal Officer Curran Simpson - President & CEO Steve Pakola - Chief Medical Officer Mitch Chan - CFO Conference Call Participants Mani Foroohar - Leerink Partners Gena Wang - Barclays Judah Frommer - Morgan Stanley Annabel Samimy - Stifel Paul Choi - Goldman Sach...

FDA assigns PDUFA target action date of November 9, 2025 RGX-121 on track to be the first gene therapy and one-time treatment for MPS II Partner Nippon Shinyaku to lead commercialization upon potential approval REGENXBIO to lead commercial manufacturing and supply chain ROCKVILLE, Md. , May 13, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the U.S. Food and Drug Administrat...

RGX-202 in Duchenne muscular dystrophy on track for BLA submission mid-2026 Pivotal trial more than half enrolled, with completion expected in 2025  Additional Phase I/II functional data expected 1H 2025  Initiating commercial supply manufacturing in Q3 2025 FDA acceptance of Biologics License Application (BLA) for clemidsogene lanparvovec (RGX-121, partnered with Nippon Shinyaku) expected in M...