News

Sarepta’s Elevidys Halted at Children’s Hospital Los Angeles
Children’s Hospital Los Angeles paused the use of Sarepta Therapeutics Inc.’s gene therapy for Duchenne muscular dystrophy in the wake of rising safety concerns about liver toxicity, adding to ...
Children's Hospital LA pauses use of Sarepta gene therapy for all patients
Children's Hospital Los Angeles, citing recent U.S. Food and Drug Administration actions, on Monday said it has paused usage of Sarepta Therapeutics' gene therapy Elevidys in all patients with ...
BioPharma Dive3h
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 Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy
After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy to ambulatory people but maintain a halt it implemented June 15 for ...
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 ...
STAT4hOpinion
The crisis over Sarepta’s Duchenne therapy is a mess. But the lesson is clear
The crisis over Sarepta Therapeutics' Duchenne therapy offers a valuable lesson: Listening to critics, and responding with ...
Sarepta shares cut to $0 at H.C. Wainwright
H.C. Wainwright sets a rare $0 target for Sarepta Therapeutics amid FDA scrutiny over its Duchenne muscular dystrophy gene therapy Elevidys. Read more here.
Biogen invests $2B in U.S. manufacturing — but not in Massachusetts
Biogen is investing $2 billion in its U.S. manufacturing footprint — but not in Massachusetts, where the drug company is ...
MedPage Today6h
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 ...
BioPharma Dive6h
5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis
A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...
Sarepta Therapeutics stock sinks after FDA tells company to stop shipping its bestselling drug
Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...
Becker's Hospital Review7h
Sarepta to continue shipping gene therapy despite patient deaths
Sarepta Therapeutics said it will continue shipping its gene therapy Elevidys for Duchenne muscular dystrophy patients despite an FDA request to pause distribution following multiple patient deaths.