FDA Impact on Sarepta

Order byBest matchMost fresh

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 · 1d

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

pharmaphorum · 1d

Third death reported with a Sarepta gene therapy

· 17h

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

Drugmaker Sarepta Therapeutics said late Friday it won’t comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy following the death of a third patient r...

· 1d

Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says

· 1d

FDA to ask Sarepta to stop shipping Duchenne gene therapy

· 1d

Sarepta Says It Won't Comply With FDA Request to Stop Shipping Gene Therapy Elevidys

Wall Street analysts have said the third death could amplify patient hesitancy to use Elevidys, given both the therapies use the same delivery vehicle known as adeno-associated virus vector.

· 1d

Sarepta shares plunge 40% as future of its gene therapy appears at risk

· 1d

Exclusive: US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says

Managed Healthcare Executive19h

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 following treatment with a gene therapy, marking the third death linked to the company's experimental treatments.

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 downgrading SRPT stock from Hold to Sell.

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 Therapeutics adds a black box warning to the gene therapy for acute liver injury and failure and parts with more than a third of employees.

Fierce Biotech3d

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, or 36% of its workforce,

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 investment analysis.

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.