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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 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 (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 ...
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.
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 ...
Zinger Key Points 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.
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.
Under this agreement, Roche and Sarepta share the Research & Development cost associated with obtaining and maintaining regulatory approvals for Elevidys in the U.S. and the EU. As reported in ...
A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.
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