Heron flying lower after CRL

30 June 2020

US biotech Heron Therapeutics (Nasdaq: HRTX) was one of a number of companies to announce on Monday that it had received a complete response letter (CRL) from the US Food and Drug Administration (FDA).

The CRL relates to the company’s New Drug Application (NDA) for HTX-011 for the management of postoperative pain.

According to the letter, the FDA is unable to approve the NDA in its present form based on the need for additional non-clinical information. The agency did not identify any clinical safety or efficacy issues or CMC issues.

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