Heron Therapeutics plunges as FDA delays decision on postoperative pain NDA

1 May 2019

Heron Therapeutics (Nasdaq: HRTX) saw its shares drop as much as 31% after the company revealed it had received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application (NDA) for HTX-011 for the management of postoperative pain.

Heron’s shares were still down 19.5% at $17.45 by mid-morning.

The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional CMC and non-clinical information. Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues, and there is no requirement for further clinical studies or data analyses.

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