Sarepta Backs Down and Pauses Elevidys Shipments

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Sarepta Therapeutics cuts 21 Durham jobs amid FDA scrutiny, broader layoffs

Sarepta Therapeutics has laid off 21 employees in Durham as part of a companywide cut of 493 jobs, following FDA concerns over patient deaths linked to its gene therapy Elevidys. The Massachusetts-based biotech also paused U.S. shipments and saw its stock plunge nearly 90% this year. Sarepta has longstanding ties to the Triangle.

Roche Pauses Global Shipments of Elevidys Gene Therapy

Roche Pauses Global Shipments of Elevidys Gene Therapy Roche Holding AG has announced a temporary suspension of its muscular disorder gene therapy, Elevidys, shipments to countries outside the United States. This decision follows a similar action by its U.S. partner, Sarepta Therapeutics, highlighting a regulatory cautionary stance.The suspension, effective from Tuesday, impacts new Elevidys orders in countries that refer to the U.S. Food and Dr…

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that have attracted attention from regulators.

In a Reversal, Sarepta Says It Will Pause Shipments of Gene Therapy Linked to Deaths

In a reversal, the drugmaker Sarepta Therapeutics said July 21 it is stopping all shipments of a gene therapy that has been linked to multiple deaths. Sarepta said in a statement it will voluntarily, and temporarily, halt all shipments of Elevidys at the close of business on July 22. Elevidys is a gene therapy treatment for Duchenne muscular dystrophy, a disorder that is inherited and features weakening muscles and increasing difficulty moving. …

Sarepta Warnings Came Long Before Its Standoff With US Regulators

Hi, it’s Bob in New York. Sarepta Therapeutics announced it will pause all shipments of Elevidys in the US. I spoke to one mother who tried to raise the alarm bell a month before the FDA took action, but first...