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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 ...
BioSpace8h
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
The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...
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 ...
Clinical Trials Arena on MSN13h
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% ...
Managed Healthcare Executive3d
FDA Wants Elevidys Off the Market. Sarepta Said No.
Elevidys is a gene therapy approved to treat Duchenne muscular dystrophy. Last month, Sarapta halted sales of the therapy for non-ambulatory patients.
Yahoo8y
FDA approves Sarepta’s controversial drug for Duchenne ... - Yahoo
The decision came after a protracted debate about whether drug maker Sarepta Therapeutics had provided enough evidence that its medication, called eteplirsen, had meaningful impact on patients.
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 ...