News

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 ...
Southwest Journal7d
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% ...
BioSpace2d
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 ...
BioSpace3d
Sarepta Concedes to FDA Request, Suspends US Shipments of Elevidys
After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...
Sarepta Therapeutics, Inc. (SRPT) Strategic Restructure and ELEVIDYS Label Update Call Transcript
Sarepta Therapeutics, Inc. ( NASDAQ: SRPT) Strategic Restructure and ELEVIDYS Label Update Conference Call July 16, 2025 4:30 PM ET Douglas S. Ingram - President, CEO & Director Ian Estepan - ...
BioPharma Dive1d
Abivax stock soars on trial data for ulcerative colitis drug
The French biotech is developing a new drug approach in a disease market that’s projected to grow to $30 billion by 2030.
Devdiscourse3d
Health and Innovation: Elderly Fitness, Corporate Battles, and Medical Advances
Recent developments in the health sector include fitness classes helping Ugandan women fight noncommunicable diseases, Humana's legal challenge to US Medicare star ratings downgrades, Sarepta pausing ...
BioPharma Dive14d
FDA turns back Capricor’s Duchenne cell therapy
The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...
STAT2d
Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says
Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the ...
InvestorsHub on MSN1h
Sarepta shares drop after EU regulators reject Elevidys gene therapy
Shares of Sarepta Therapeutics Inc. (NASDAQ:SRPT) plunged 13% on Friday after a major regulatory blow in Europe. The European ...
STAT2d
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 ...
Sarepta’s Duchenne Therapy Sparked Fears Even Before FDA’s Order
There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.