sarepta duchenne muscular dystrophy

News

FDA, Sarepta Therapeutics and Duchenne

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.

STAT · 12h

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.

BioPharma Dive · 11h

FDA allows Sarepta to resume some Elevidys shipments

The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by safety concerns.

20h

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

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...

37mon MSN

Sarepta Stock Just Soared 45%. Here’s Why.

Shares of Sarepta were up 44% to $19.98 before the market open. Coming into Tuesday trading, shares have fallen 90% over the past 12 months.

16h

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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