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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 ...
Second death linked to Sarepta Therapeutics treatment leaves Duchenne muscular dystrophy community reeling, Elevidys use halted in non-ambulatory patients.
In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...
Sarepta Therapeutics said a second patient had died after receiving its $3.2 million gene therapy to treat Duchenne muscular dystrophy.
Sarepta Therapeutics has followed through on its promise to file for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD), as it aims for a launch in the middle ...
The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...
Capricor’s BLA for Deramiocel was granted Priority Review in March 2025 and was supported by data from the HOPE-2 trial, its open-label extension (OLE), and natural history comparisons from FDA-funded ...
Sarepta is facing a shareholder lawsuit over ELEVIDYS-related deaths. Robbins LLP cites safety risks and stock losses.
Duchenne Muscular Dystrophy Market Size, Epidemiology, In-Market Drugs Sales, Pipeline Therapies, and Regional Outlook ...
The company said it was optimistic that the issues identified by the Food and Drug Administration could be resolved with new data.
Robbins LLP reminds stockholders that a class action was filed on behalf of investors who purchased or otherwise acquired Sarepta Therapeutics, Inc.
About Robbins LLP : A recognized leader in shareholder rights litigation, the attorneys and staff of Robbins LL have been dedicated to helping shareholders recover losses, improve corporate governance ...