The U.S. Food and Drug Administration (FDA) on Monday extended its review timeline for REGENXBIO Inc.'s RGNX Biologics License Application (BLA) for clemidsogene lanparvovec (RGX-121) for Mucopolysacc
RGX-121 would be the first and only potential one-time commercially-available therapy designed to directly address the underlying genetic cause of Hunter syndrome, if approved Commercial launch plans
REGENXBIO Inc. (NASDAQ:RGNX ) Q2 2025 Earnings Call August 7, 2025 8:00 AM ET Company Participants Curran M. Simpson - President, CEO & Director Mitchell Chan - Executive VP & CFO Patrick J.
Regenxbio (RGNX) came out with a quarterly loss of $1.38 per share versus the Zacks Consensus Estimate of a loss of $1.13. This compares to a loss of $1.05 per share a year ago.
RGX-202 in Duchenne muscular dystrophy on track for topline results 1H 2026 and BLA submission mid-2026 Pivotal trial enrollment accelerated, expected to complete in October 2025 ahead of previous gui
A pivotal Phase IIb/III clinical trial using suprachoroidal delivery for treatment of diabetic retinopathy will be initiated New Phase II ALTITUDE ® trial data demonstrate a durable safety and effica
ROCKVILLE, Md. , July 31, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Thursday, August 7, at 8:00 a.m.
Construct including CT domain demonstrated higher levels of microdystrophin protein, increased muscle force, and improved resistance to damage in mice lacking dystrophin REGENXBIO's next-generation in
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 d
RegenXBio Inc. RGNX revealed new interim data on Thursday from the Phase 1/2 AFFINITY DUCHENNE trial.
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 Bi
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) a
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 - Chie
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