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FDA takes U-turn on Sarepta’s Elevidys, backing Duchenne gene therapy again in ambulatory patients
On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just 10 days after the agency requested that the company halt all shipments of the one-time treatment following reports of three deaths among patients who had received a Sarepta gene therapy, including two on Elevidys.
The European Medicines Agency’s drug advisory committee (CHMP) rejected Elevidys for children aged 3 to 7 years who are able ...
The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...
Sarepta (SRPT) Therapeutics shared the following update related to ELEVIDYS, the only approved gene therapy in patients with Duchenne muscular dystrophy. Following the safety update on acute liver ...
CAMBRIDGE, Mass., April 04, 2025--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, shared the following update related to ELEVIDYS ...
Sarepta Therapeutics (SRPT) stock drops as the EU officials request a clinical hold on trials involving its gene therapy Elevidys after a patient death. Read more here.
Sarepta and Roche paused multiple Elevidys trials in the EU at the EMA’s request. HC Wainwright upgraded Sarepta to Neutral but sees Elevidys sales falling by Q2 2025. Up Next: Get 5 Dark ...
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 Therapeutics submitted a request to the FDA for label expansion of Elevidys, with a response expected by June 21st. Read why SRPT stock is a buy.
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