News

FDA Probes Death of Boy in Brazil on Sarepta’s Elevidys
US regulators are investigating the death of an 8-year-old boy in Brazil who received Sarepta Therapeutics Inc.’s Elevidys.
Fierce Pharma13h
FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault
In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...
BMO Capital Cuts Sarepta Therapeutic (SRPT) PT to $25 from $50
Sarepta Therapeutics Inc. (NASDAQ:SRPT) is one of the most undervalued stocks to buy and hold for 3 years. On July 22, BMO ...
Fierce Pharma4d
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 ...
BioSpace3d
Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
Sarepta Therapeutics to Lift Pause on Shipments of Duchenne Treatment Elevidys
Sarepta Therapeutics said the Food and Drug Administration informed the company it can lift a voluntary pause on shipments of Elevidys for ambulatory patients with Duchenne. The company said Monday ...
Sarepta will resume gene therapy shipments after fda review of recent patient death
Shares of beleaguered drugmaker Sarepta Therapeutics jumped in afterhours trading Monday after the company said it would ...
BioSpace6d
Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle
Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, ...
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 ...
Devdiscourse6d
Roche Pauses Shipments of Muscular Disorder Gene Therapy Elevidys Amid Safety Concerns
Roche Holding AG has temporarily halted shipments of the gene therapy Elevidys in some countries outside the U.S. following a ...
Stocktwits on MSN23h
Retail Bulls Stick With Sarepta After 8-Year-Old Patient’s Death Deemed Unrelated To DMD Gene Therapy
Retail sentiment around Sarepta Therapeutics remained upbeat on Monday after the company said Friday that the death of an ...
Clinical Trials Arena on MSN6d
Sarepta refuses to pull gene therapy despite FDA request
Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the FDA.