The FDA called for Sarepta Therapeutics to stop shipping its muscular dystrophy gene therapy, but the company said no.

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...

The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...

The death of a third patient tied to a Sarepta Therapeutics gene therapy this year sent the company’s shares nosediving 36% Friday, halting the momentum the stock generated just a day earlier after ...

The head of the US Food and Drug Administration said the agency will “take a hard look” at a gene therapy from Sarepta Therapeutics Inc. after two patient deaths, adding pressure to the biotech ...

Sarepta faces competition in the gene therapy space from companies like Avidity Biosciences and Dyne Therapeutics, which are developing their own approaches to treating muscular dystrophies.

In June, Sarepta reported a second death in a patient who had received its gene therapy, which raised concerns about the safety and future demand for the treatment. Both boys were non-ambulatory ...

SAN DIEGO, June 30, 2025 (GLOBE NEWSWIRE) -- Robbins LLP informs stockholders that a class action was filed on behalf of investors who purchased or otherwise acquired Sarepta Therapeutics, Inc.

Allegations in the Complaint Sarepta is a biopharmaceutical company focused on genetic medicine, including its gene therapy product ELEVIDYS, developed for the treatment of Duchenne muscular ...

The complaint alleges that biopharmaceutical company Sarepta was engaged in the development of ELEVIDYS, a gene therapy intended to treat patients with Duchenne muscular dystrophy.

Today's biotech news features an FDA probe into the deaths tied to Sarepta's Duchenne drug, rejecting KalVista's drug application, etc.