Fierce Pharma

FDA outlined concerns with Elevidys' manufacturing at Catalent site, Form 483 shows

Catalent’s sweeping workforce reductions within its Maryland gene therapy manufacturing operations were preceded by two FDA inspections in April that resulted in red flags from the agency, FDA fili | ...
Seeking Alpha

What’s behind Sarepta’s gene therapy deaths?

Three patient deaths linked to neuromuscular drugs developed by Sarepta Therapeutics (NASDAQ:SRPT) have drawn regulatory scrutiny on the viral vector used in the company’s gene therapy platform ...

Sarepta’s Elevidys safety concerns open major opportunity for Solid Biosciences’ (SLDB) SGT-003 in Duchenne therapy

Solid Biosciences Inc. (NASDAQ:SLDB) is one of the stocks that will double in 2026. On December 4, Needham analyst Gil Blum ...
KTVB

FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths

WASHINGTON(AP) — The Food and Drug Administration said Friday it will add a new warning and other limitations to a gene therapy for Duchenne’s muscular dystrophy that's been linked to two patient ...
Click2Houston

Sarepta will resume gene therapy shipments after FDA review of recent patient death

WASHINGTON – Shares of beleaguered drugmaker Sarepta Therapeutics jumped in afterhours trading Monday after the company said it would resume shipping its gene therapy for some patients, following a ...
Benzinga.com

Sarepta Gets Thumbs Down From Regulators Regarding Elevidys Gene Therapy

CHMP issued a negative opinion on Elevidys for Duchenne patients aged 3–7 despite secondary gains in motor function. Elevidys has treated over 900 DMD patients, but EMA and FDA raise concerns over ...
Seeking Alpha

Gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths

WASHINGTON (AP) — Drugmaker Sarepta Therapeutics (SRPT) said late Friday it won't comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy following the ...