News

FDA opens probe into mysterious death linked to gene therapy
The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne ...
FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy
The patient with Duchenne muscular dystrophy, who died in Brazil, was treated with Elevidys but was not a participant in a ...
Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...
Fierce Pharma2d
FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report
Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...
MIT Technology Review1d
The deadly saga of the controversial gene therapy Elevidys
The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.
Investor's Business Daily on MSN2d
The Hits Keep Coming For Sarepta. Why Its Latest Setback Creates A 'Dangerous Precedent' For Gene Therapies.
Sarepta stock plunged again Thursday on a report that the Food and Drug Administration will require additional clinical ...
Sarepta Therapeutics: Why Is SRPT Stock Crashing?
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.