News

FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
Sarepta shares slump after third patient death this year
Shares of Sarepta Therapeutics declined 17% in early trading on Friday after another patient who had received an experimental ...
What’s behind Sarepta’s gene therapy deaths?
Three patient deaths linked to gene therapies developed by Sarepta Therapeutics (SRPT) have drawn FDA scrutiny on the viral ...
Sarepta reports patient death in limb-girdle trial, compounding concerns on gene therapy risks
The death of a 51-year-old man in the study follows two other deaths of Duchenne patients treated with Sarepta’s marketed gene therapy Elevidys.
Sarepta Therapeutics stock sinks further Tuesday after halting shipment of bestselling drug Elevidys
Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...
Fierce Biotech5d
Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...
STAT8d
Patient dies in Sarepta gene therapy trial, adding to safety concerns
A 51-year-old man died last month after receiving an experimental treatment from Sarepta, the third death this year tied to ...
Sarepta Stock Continues to Fall After Patient Death Linked to Investigational Gene Therapy
Also on Friday, the Food and Drug Administration informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, which is approved to treat a different type of ...
Southwest Journal8d
Breaking: Second Patient Death Prompts FDA Investigation of Sarepta’s Elevidys Gene Therapy
Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...
Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths
The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from ...
Sarepta drops as report suggests FDA needs new trials for Elevidys
Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...
BioPharma Dive5d
FDA asks Sarepta to stop shipping Duchenne gene therapy
The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...