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Heron Gets CRL For HTX-011 For Management Of Postoperative Pain; Stock Down

Heron Therapeutics Inc. (HRTX) said that it received a Complete Response Letter or CRL from the U.S. Food and Drug Administration regarding its New Drug Application for HTX-011 for the management of postoperative pain.

In Monday pre-market trade, HRTX is trading at $17.55, down $2.27 or 11.45 percent.

The Complete Response Letter has requested additional non-clinical information. The FDA did not identify any clinical safety or efficacy issues or CMC issues, the company said in a statement.

There are four non-clinical issues in the CRL, none of which relate to any observed toxicity, the company said. Three relate to confirming exposure of excipients in preclinical reproductive toxicology studies, and the fourth relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage.

The company noted that it will request a Type A meeting to obtain agreement with the Agency on its responses and resubmit the application as quickly as possible.

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