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August 6, 2021

Sarepta says FDA asks for more data for its muscle-wasting treatment

(Reuters) – Sarepta Therapeutics Inc said the U.S. Food and Drug Administration has requested for additional data for its muscle-wasting treatment as the agency decides whether to approve the drug or not.

Shares of the company rose 24 percent to $19.90 in extended trading on Monday.

The FDA deferred a highly anticipated decision on whether to approve Sarepta’s drug, eteplirsen, last month, after an advisory panel determined that the treatment was not effective.

The agency requested that Sarepta provide dystrophin data from biopsies already obtained from the ongoing confirmatory study of eteplirsen, the company said on Monday.

Sarepta’s drug has been in the spotlight over the past few months with patient groups and parents arguing passionately in favor of the treatment to pressure the regulator to approve the drug.

Duchenne muscular dystrophy is a rare genetic disorder characterized by progressive muscular weakness and is caused by a lack of dystrophin, a protein needed to keep muscles healthy. Eteplirsen is designed to increase the production of dystrophin.

Sarepta said on Monday that it plans to submit data from thirteen patient biopsy samples to the FDA over the coming weeks to facilitate a prompt decision by the agency.

(Reporting by Ankur Banerjee in Bengaluru; Editing by Shounak Dasgupta)

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