News

STAT1h
Roche halts some shipments of Sarepta’s Duchenne gene therapy outside U.S.
Roche is following its partner Sarepta and halting shipments of the Duchenne gene therapy Elevidys in some countries, amid ...
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 ...
Sarepta Faces Regulatory Showdown As Analysts Cut Price Targets
Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty ...
Sarepta under pressure: FDA requests halt of Elevidys shipments
Sarepta Therapeutics (SRPT) stock is in focus after the US Food and Drug Administration (FDA) asked the company to halt ...
Why Sarepta's halted drug Elevidys is an issue for investors
Sarepta (SRPT) paused shipments of its top-selling gene therapy drug after the US Food and Drug Administration (FDA) raised safety concerns tied to liver toxicity. Yahoo Finance Senior Reporter ...
BioSpace19h
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 ...
FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths
Sarepta Therapeutics Inc. said another patient has died from acute liver failure after receiving one of its gene therapies, ...
Clinical Trials Arena on MSN1d
Sarepta refuses to pull gene therapy despite FDA request
Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the FDA.
India Today on MSN1d
Children's Hospital LA halts use of Sarepta's gene therapy for all patients
Children’s Hospital Los Angeles paused Sarepta’s Elevidys gene therapy after FDA flagged safety issues, including deaths in ...
Southwest Journal4d
Breaking: Second Patient Death Prompts FDA Investigation of Sarepta’s Elevidys Gene Therapy
Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...
FierceBiotech2y
FDA questions benefits, risks of Sarepta DMD gene therapy - Fierce Biotech
The FDA has had concerns about the clinical benefit of SRP-9001 since as far back as December 2018, when the agency questioned the surrogate endpoint and recommended that Sarepta pick one “that ...