Sarepta Stock falls on the FDA -Gent therapy -Pidys comments.

Shares of Sarepta therapeutics More than 30%fell on Friday when the future of approved gene therapy was endangered.

The Food and Drug Administration will apply for the company to voluntarily stop all programs, Eldys, a person who is familiar with the matter, said CNBC.

Sarepta said CNBC that the FDA did not hear it.

Regardless of this, the FDA Commissioner Marty Makary told Bloomberg News that the agency was considering whether the company's gene therapy should remain on the market.

The FDA examines two deaths of patients who are bound to Eltidys. The company also reported a third death that was bound to separate experimental gene therapy.

Eldys was involved in controversy in controversy before approval. Gent therapy must still clearly prove that it can benefit people with Duchenne muscle dystrophy, an illness that undermines muscle function over time.

After all, people with the disease lose the ability to run, and most of them die in their early 20s, which means that there is a large, uncovered need for treatment. In 2023, the FDA originally granted an elemented eligent for patients between 4 and 5 years, the group, which had the greatest benefit in clinical studies.

The following year, the agency of treatment gave patients 4 and older who still go and the approval for patients 4 and on accelerated people who could no longer run. The latter decision was particularly controversial because there was fewer indications that Elefidy's people could help people whose illness had already made so much progress.

In addition, Elefidys did not confront his goal in a phase -3 study, although the company argued that the medication showed promising for other metrics in the study. Subsequently, Peter Marks von Sarepta's assessment of Sarepta's assessment and research manager of the FDA assessment and examination of the FDA employees to expand the approval of Elefidys.

The company's share has fallen more than 87% this year.

– Angelica Peebles from CNBC contributed to this report

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