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

Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% as company halts non-ambulatory patient treatments.

pharmaphorum · 2d

Third death reported with a Sarepta gene therapy

A third fatality has been recorded among patients receiving treatment with a Sarepta gene therapy, adding to the troubles being faced by the company.

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, ...

Yahoo8y

FDA approves Sarepta’s controversial drug for Duchenne ... - Yahoo

The decision came after a protracted debate about whether drug maker Sarepta Therapeutics had provided enough evidence that its medication, called eteplirsen, had meaningful impact on patients.

Benzinga.com1y

Sarepta's Expanded FDA Approval For Elevidys Potentially ... - Benzinga

FDA approves Sarepta's Elevidys for Duchenne muscular dystrophy patients with confirmed DMD gene mutation, aged 4+. Expanded label boosts revenue prospects for SRPT as payers and analysts show ...

FierceBiotech2y

FDA questions benefits, risks of Sarepta DMD gene therapy - Fierce Biotech

The FDA has had concerns about the clinical benefit of SRP-9001 since as far back as December 2018, when the agency questioned the surrogate endpoint and recommended that Sarepta pick one “that ...

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