News

BioSpace9h
Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle
Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the ...
STAT10h
Pharmalittle: We’re reading about Sarepta conceding to the FDA, the U.S. transplant system, and more
Sarepta Therapeutics reversed course and agreed to halt all shipments of Elevidys, its gene therapy for Duchenne muscular ...
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 ...
BioPharma Dive1d
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 ...
MyChesCo on MSN1d
FDA Shuts Down Sarepta Gene Therapy Trials After Three Deaths Linked to Liver Failure
The U.S. Food and Drug Administration on Friday placed Sarepta Therapeutics’ gene therapy trials for limb girdle muscular ...
MPR1d
Third Death Prompts FDA Action on Sarepta’s Gene Therapy Products
The third death occurred in an adult male with limb girdle muscular dystrophy who received a Sarepta AAVrh74 gene therapy product, SRP-9004, in a phase 4 clinical trial.
Fierce Biotech1d
Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle ...
Cambridge pharma company lays off almost 500 amid FDA dispute over treatment
A Cambridge-based company developing gene therapies for rare diseases is laying off more than a third of its workforce.
FDA Places Sarepta's Investigational Gene-Therapy Trials on Hold Following Patient Death
Separately, the FDA on Friday informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, that is approved to treat a different type of muscular dystrophy and was ...
Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys
FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due ...
Stocktwits on MSN1d
GlucoTrack, Sarepta, TNF Pharma Dominate Weekly Retail Health Care Buzz — Here’s Why
Retail chatter spiked last week as investors piled into three healthcare stocks: GlucoTrack, Sarepta Therapeutics, and TNF ...
FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...