Roche Holding AG said on Tuesday it has paused shipments of muscular disorder gene therapy Elevidys in some countries outside ...

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

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

The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...

The company had previously halted shipments to certain older patients following the deaths of two teenagers treated with the ...

In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...

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

Sarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.

Analysts downgraded Sarepta as FDA pause on Elevidys raises regulatory uncertainty, leading to significant stock pressure and ...

Sarepta Therapeutics (SRPT) stock is back in focus as Roche (RHHBF) pauses global shipments of its Elevidys gene therapy ...

Discovered and developed by Sarepta Therapeutics, Elevidys is a gene therapy that won accelerated approval in June 2023 and ...

Sarepta Therapeutics (SRPT) said late Monday it will pause all shipments of its Duchenne muscular dystrophy gene therapy, ...