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Sarepta Therapeutics shares sank to their lowest level in nine years Monday after a second patient taking its Elevidys drug ...
Sarepta announced on Sunday that shipments of Elevidys to non-ambulatory patients are suspended until an enhanced immunosuppressive regimen is approved to mitigate the risk of acute liver failure.
The U.S. Food and Drug Administration said on Tuesday that it is investigating reports of two deaths due to acute liver failure in non-ambulatory Duchenne muscular dystrophy patients after receiving ...
Sarepta is facing a shareholder lawsuit over ELEVIDYS-related deaths. Robbins LLP cites safety risks and stock losses.
Sarepta Provides Safety Update for ELEVIDYS and Initiates Steps to Strengthen Safety in Non-Ambulatory Individuals with Duchenne Provided by Business Wire Jun 15, 2025, 5:00:00 AM.
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
Sarepta Therapeutics said a second patient had died after receiving its $3.2 million gene therapy to treat Duchenne muscular dystrophy.
Like the first death reported in March, Sarepta Therapeutics attributed the fatality to a case of acute liver failure following dosing of the Duchenne muscular dystrophy gene therapy, Elevidys.
According to Sarepta, the patient was the second to succumb to acute liver failure (ALF) after being treated with Elevidys, which is the only gene therapy that has won FDA approval as a treatment ...
FDA is investigating Sarepta's Elevidys after two deaths from liver failure in non-ambulatory DMD patients, raising safety and regulatory concerns.
Like the first death reported in March, Sarepta Therapeutics attributed the fatality to a case of acute liver failure following dosing of the Duchenne muscular dystrophy gene therapy, Elevidys ...
Sarepta disclosed the first patient death — a 16-year-old boy — in March. Both occurred from acute liver failure, a side effect that has been seen with other gene therapies.