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Sarepta Therapeutics, FDA and Duchenne
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The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...
The European Medicines Agency’s drug advisory committee (CHMP) rejected Elevidys for children aged 3 to 7 years who are able ...
Sarepta Therapeutics (NASDAQ:SRPT) fell ~38% in the premarket on Monday after the company reported a second fatality from acute liver failure in a patient treated with Elevidys, a gene therapy ...
A second patient has died following treatment with Sarepta Therapeutics’ Elevidys, raising more doubts about the Duchenne muscular dystrophy (DMD) gene therapy’s safety profile. Sarepta and ...
FDA confirms two fatal cases of liver failure in DMD patients treated with Elevidys HC Wainwright reiterates Sell rating on Sarepta, with a $10 price target Tim Melvin’s system has spotted 10X ...
So, Sarepta is making efforts with EU regulators to lift the pauses. In May, Sarepta’s stock dropped further after it lowered its 2025 revenue guidance from $2.9 billion - $3.1 billion to $2.3 ...
Sarepta Therapeutics has temporarily suspended use of the gene therapy Elevidys in non-ambulatory patients with Duchenne muscular dystrophy (DMD) after a second patient taking the drug died from ...
A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.
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