News

FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy
The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...
Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
BioPharma Dive4d
5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis
While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...
Precision Medicine Online1d
Sarepta Halts Duchenne Gene Therapy Sales Amid FDA Scrutiny, Raising Concerns Over Financial Future
Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.
Fierce Pharma3d
Sarepta, bowing to FDA pressure, pauses shipments of Duchenne gene therapy Elevidys
A brief skirmish between Sarepta Therapeutics and the FDA has ended before escalating into a full-on regulatory clash, as the company has bowed to the agency’s demand. | A brief skirmish between ...
Investor's Business Daily on MSN4d
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 ...
Sarepta shares fall 37% as FDA questions future of key gene therapy
Shares of Sarepta Therapeutics fell close to 37% on Friday after reports emerged that the US Food and Drug Administration is ...
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.
Managed Healthcare Executive6d
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.
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 to safety concerns.
Business Times6d
Sarepta Shares Plunge 38% After Third Gene Therapy Death Sparks FDA Scrutiny
Sarepta Therapeutics saw its shares plunge more than 35% Friday after a third patient death tied to its gene therapy programs deepened regulatory scrutiny and rattled investor confidence. The Food and ...