News

Sarepta extends losses premarket after refusing FDA’s halt request
Sarepta Therapeutics (SRPT) shares fell as much as 4.8% in premarket trading Monday, poised to extend losses for a second ...
MedPage Today9h
Drugmaker Refuses FDA's Request to Pull Gene Therapy Tied to Patient Deaths
The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...
Sarepta to pause Elevidys gene therapy shipments in US
Sarepta Therapeutics said on Monday it will pause all shipments of Elevidys in the United States after two teenage boys with a rare condition called Duchenne muscular dystrophy, who had received the ...
Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy
U.S. regulators recently asked Sarepta Therapeutics to voluntarily halt shipments of its Elevidys gene therapy after a ...
Devdiscourse47m
Sarepta Suspends Gene Therapy Shipments After Tragic Deaths
Sarepta Therapeutics has paused U.S. shipments of its gene therapy Elevidys after two teenagers with Duchenne muscular ...
Sarepta to pause gene therapy Elevidys shipments in US
Sarepta Therapeutics said on Monday that it will pause all shipments of its Elevidys gene therapy in the United States after a muscular dystrophy patient who received a different, experimental ...
Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys
The ground shook for Sarepta Therapeutics, Inc. (NASDAQ:SRPT) last week as the U.S. Food and Drug Administration (FDA), ...
WBUR13h
Cambridge-based gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics said late Friday it won't comply with a request from the Food and Drug Administration to halt ...
BioPharma Dive6h
FDA asks Sarepta to stop shipping Duchenne gene therapy
The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...
Sarepta slides as FDA places clinical hold on gene therapy clinical trials
Sarepta Therapeutics faces challenges as the FDA halts gene therapy trials for LGMD and revokes AAVrh74 platform designation.
Devdiscourse2h
Sarepta Halts Elevidys Gene Therapy Shipments
Sarepta Therapeutics will pause all U.S. shipments of its Elevidys gene therapy following the death of a muscular dystrophy patient who received an experimental treatment. Initially resisting ...