Sarepta Therapeutics Inc. (SRPT) announced after the bell Monday that the FDA has requested additional information from the existing eteplirsen dataset to inform a decision on the acceptability of this dataset for a New Drug Application filing under the Subpart H Accelerated Approval regulatory pathway.
Sarepta Therapeutics has gapped open sharply lower Tuesday morning and is now down 4.68 at $34.56. The stock has dropped to over a one-week low.
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