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Sarepta Therapeutics shares sank to their lowest level in nine years Monday after a second patient taking its Elevidys drug ...
Brokerage H.C. Wainwright on Wednesday opined that there will be” little intrinsic value” in Sarepta Therapeutics (SRPT) if its cell therapy for Duchenne Muscular Dystrophy called Elevidys is ...
The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...
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.
Sarepta is facing a shareholder lawsuit over ELEVIDYS-related deaths. Robbins LLP cites safety risks and stock losses.
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.
FDA is investigating Sarepta's Elevidys after two deaths from liver failure in non-ambulatory DMD patients, raising safety and regulatory concerns.
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.
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 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.
Additionally, Sarepta has paused dosing in the ENVISION trial (ClinicalTrials.gov Identifier: NCT05881408), a randomized, double-blind, placebo-controlled study evaluating Elevidys in older ...