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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 ...
Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...
The European Medicines Agency’s drug advisory committee (CHMP) rejected Elevidys for children aged 3 to 7 years who are able ...
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 ...
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 Dive on Second Fatal Liver Failure Tied to Elevidys Published: June 16, 2025 at 6:33 a.m. ET Share Resize ...
This established skepticism from Dr. Prasad, even prior to the recent reports of liver failure deaths, suggests a likely reluctance to support Sarepta’s continued marketing of Elevidys.
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