sarepta therapeutics duchenne muscular dystrophy

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Sarepta Will Resume Gene Therapy Shipments

FDA takes U-turn on Sarepta’s Elevidys, backing Duchenne gene therapy again in ambulatory patients

On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just 10 days after the agency requested that the company halt all shipments of the one-time treatment following reports of three deaths among patients who had received a Sarepta gene therapy, including two on Elevidys.

The Associated Press on MSN · 48m

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 resume shipping its gene therapy for some patients, following a brief pause requested by regulators.

STAT · 4h

FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt

The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular dystrophy to some patients.

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 ...

FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys

The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...

Duchenne Muscular Dystrophy Market to Witness Significant Expansion During the Forecast Period (2025–2034) Amidst Advances in Gene Therapy and Novel Drug Approvals | DelveInsight

The Duchenne muscular dystrophy market is witnessing steady growth driven by advancements in gene therapies, exon-skipping drugs, and corticosteroid alternatives. Increasing diagnosis rates, rising ...

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