Heron Therapeutics (NASDAQ:HRTX) is down 11% premarkket in reaction to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its NDA for HTX-011 for the management of postoperative pain.
The CRL stated that 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 chemistry, manufacturing and controls issues. There are four non-clinical issues in the CRL, none of which relate to any observed toxicity.
The Company will request a Type A meeting to obtain agreement with the Agency and resubmit the application as quickly as possible.
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