Sarepta Gene Therapy Risks - Search News

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Sarepta, FDA and Gene Therapy

Men's Journal on MSN · 2d

Sarepta’s Risky Gamble: Gene Therapy Stays on Market Despite FDA Request

When three patients die after taking a cutting-edge drug, most companies hit the brakes. Not Sarepta Therapeutics. The Massachusetts-based biotech company is under fire for refusing a request from the U.

The Columbus Dispatch on MSN · 1h

Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy to ambulatory people but maintain a halt it implemented June 15 for non-ambulatory patients after reporting to the FDA a case of acute liver failure in a patient who could not walk.

BioPharma Dive · 23h

FDA asks Sarepta to stop shipping Duchenne gene therapy

The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still walk. A pause on shipments to older, non-ambulatory patients remains in place.

4don MSN

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

Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its key gene therapy treatment appeared at ...

4h

Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...

Managed Healthcare Executive7h

Sarepta to Pause Shipments of the Gene Therapy Elevidys

Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators ...

BioPharma Dive1d

5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis

A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...

Fierce Biotech1d

Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle ...

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