News

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 ...
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 ...
Investor's Business Daily on MSN2h
Sarepta's 'Unprecedented Times' Continue As Company Rebukes The FDA
Sarepta stock took another dive Monday after the biotech company refused the FDA's request to voluntarily stop all shipments ...
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 ...
Sarepta shares hit as Mizuho, Leerink warn on FDA rift, credibility risk
Investing.com -- Sarepta Therapeutics came under pressure after two brokerages slashed their price targets and downgraded the stock, flagging mounting safety, regulatory, and credibility concerns ...
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.
Pharma exec to lead FDA drug unit
The FDA has named Dr. George Tidmarsh to lead its drug division, putting him at the helm of the agency’s drug approval process.
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 ...