Aditxt Shares Tank 20% Amid Sarepta Therapeutics Pipeline Concerns

Sarepta Therapeutics Shares Plunge After FDA Rejects Exondysso

Sarepta Therapeutics (NASDAQ: SRPT) shares plummeted over 60% on Friday after the Food and Drug Administration (FDA) rejected the company's application to expand the use of its muscular dystrophy treatment, Exondysso.

The FDA rejected Exondysso's application to treat Duchenne muscular dystrophy, a rare and debilitating genetic disorder that affects boys, citing concerns over the treatment's efficacy and safety.

Sarepta's shares fell as much as 63.5% to $23.49 per share, wiping out over $2.5 billion in market value, before recovering slightly to $25.50 per share.

The FDA's decision comes after Sarepta's application was initially approved in 2016 for the treatment of Duchenne muscular dystrophy, but only for a specific subset of patients. The company had sought to expand the treatment's use to a broader population of patients with the disease.

Sarepta's CEO, Edward Kaye, said in a statement that the company is "disappointed" by the FDA's decision and is reviewing the agency's complete response letter to determine its next steps.

The FDA's rejection of Exondysso's application is a significant setback for Sarepta and the muscular dystrophy community, which had been hoping for a more effective treatment for the disease.

Sarepta's shares have been volatile in recent months, with the stock price falling sharply in January after the company announced that it would delay the release of its financial results due to an ongoing investigation by the FDA. The stock has since recovered some of its losses, but Friday's news sent shares plummeting once again.