Recro Pharma (REPH +11%) is up on more than double normal volume in response to the FDA granting its appeal of the Complete Response Letter (CRL) it received in March related to its marketing application for IV meloxicam.
The company is working on a comprehensive response to the agency including proposed labeling that is consistent with guidance.
Its previously announced spin out of Recro Pharma Acute Care into an independent company should be completed this quarter.
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