News

Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

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

Sarepta Soars After FDA Says Some Patients Can Get Elevidys

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients who can walk be allowed to take its gene therapy Elevidys again.The Food ...

Sarepta soars as revenue beats estimates on Elevidys milestone

Sarepta Therapeutics Inc.’s shares soared after the US biotech reported revenue that beat estimates, which analysts ...

Roche pauses shipments of Elevidys gene therapy outside US

Roche Holding AG said on Tuesday it has paused shipments of muscular disorder gene therapy Elevidys in some countries outside the U.S., echoing a similar decision by U.S. partner Sarepta Therapeutics ...

Sarepta shares rebound after shipments of gene therapy Elevidys resume in US

By Bhanvi Satija and Siddhi Mahatole (Reuters) -Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as analysts said resumption of U.S. shipments for its muscular gene therapy ...

FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

FDA’s Reversal on Gene Therapy Helps My Son

Parents of boys with Duchenne muscular dystrophy weigh in on drug innovation and medical regulation.