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FDA takes U-turn on Sarepta's Elevidys, backing Duchenne gene therapy again in ambulatory patients
Monday, the FDA said Sarepta may resume treating ambulatory DMD 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 downgraded as company suspends guidance after latest Elevidys death Jun. 16, 2025 11:31 AM ET Sarepta Therapeutics, Inc. (SRPT) Stock RHHBY, RHHBF By: Dulan Lokuwithana, SA News Editor 8 ...
Sarepta shares fell ~40% in premarket after reporting a second patient death linked to Elevidys. Sarepta halted Elevidys shipments for non-ambulatory patients and paused dosing in the ENVISION ...
Nevertheless, on the same day, Sarepta assured investors that “the benefit-risk of ELEVIDYS remains positive.” Next, on June 15, 2025, Sarepta announced that a second patient treated with ...
Despite setbacks, Sarepta’s gene therapy pipeline and market leadership in DMD present a high-risk, high-reward setup. Read more on SRPT stock here.
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