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. The stock is now down 3.69 on 503K shares.
Sarepta Therapeutics dipped in early trade Monday, but traded in a range for the bulk of the session. Shares finished down by 0.97 at $39.24. The stock pulled back slightly from resistance at the highs of the year.
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