FDA Impact on Sarepta

News

FDA to Ask Sarepta to Halt Elevidys Shipments

FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths

Sarepta Therapeutics Inc. said another patient has died from acute liver failure after receiving one of its gene therapies, putting additional pressure on the biotech company after the recent deaths of two teenage boys.

Southwest Journal · 2d

Breaking: Second Patient Death Prompts FDA Investigation of Sarepta’s Elevidys Gene Therapy

· 1d

Sarepta tells FDA it won’t halt shipments despite patient deaths

Sarepta: Despite Restructuring, Downgrading To Sell After Latest Developments

The restructuring enacted by Sarepta Therapeutics is expected to save up to $400 million in annual costs. Read why I'm ...

Managed Healthcare Executive1d

FDA Wants Elevidys Off the Market. Sarepta Said No.

Elevidys is a gene therapy approved to treat Duchenne muscular dystrophy. Last month, Sarapta halted sales of the therapy for non-ambulatory patients.

Sarepta Therapeutics Stock Plunges Over 30% In Friday Pre-Market: What's Going On

Shares of Sarepta Therapeutics (NASDAQ: SRPT) plunged 26.85% in Friday pre-market after a clinical trial participant died ...

BioSpace3d

Sarepta Tags DMD Gene Therapy Elevidys With Black Box Warning, Axes 500 Staff

Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta ...

Sarepta: Finally, A Little Relief For Bulls; I Expect More

Sarepta's cost-saving moves, FDA surprises, and pipeline potential position SRPT as a unique opportunity. Read here for an ...

Fierce Biotech4d

Sarepta pivots to siRNA and lays off 500 staffers as Elevidys gets box warning

Sarepta Therapeutics is laying off 500 staffers, or 36% of its workforce, as part of a strategic restructuring aiming to save $400 million annually. | Sarepta Therapeutics has laid off 500 staffers, ...

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