Sarepta’s promotion falls on the FDA Elevidys Comment

Shares Sarepta Therapeutics On Friday, more than 30%plunged when the future of its approved therapy, the therapy appeared in the risk zone.

The food administration and medicines asks the company to voluntarily stop all treatment supplies, said CNBC, which is familiar with this issue.

Sarett said CNBC that he didn’t hear from the FDA.

Separately Commissioner FDA Marty Makari said Bloomberg News The agency considers the question of whether the company’s gene therapy should remain on the market.

The FDA investigates two deaths of the Ellid patients. The company also reported a third death associated with a separate experimental therapy gene.

Elidis has been deepened in the dispute since he was approved. Gene therapy has yet clearly proved that it can benefit people with Duchenne muscle dystrophy, a condition that blur the muscle function over time.

People with the disease eventually lose the ability to walk, and most die until the beginning of the 20s, that is, there is a great impossible need in the treatment. In 2023, the FDA initially provided Elevidys Conditional Patients’ approval only between the ages of 4 to 5 years, in a group that saw the greatest benefit in clinical trials.

Next year, the agency provided full treatment for patients 4 and older who could go and accelerate the permission of patients 4 and above who can no longer walk. The last decision was especially controversial because there was less evidence that Elidi could help people whose illness has already progressed so much.

In addition, Elidis did not reach its goal in the trial of 3 phase, although the company claimed that the drug demonstrated the promise of other indicators in the study. Then the head of the FDA Biological Science Center, Peter Marx, agreed with Sarett’s assessment and canceled FDA staff to expand Elevidys approval.

This year, the company fell more than 87%.

– Angelica peebles cnbc contributed to this report

This story develops. Please check the updates.