Heron Therapeutics Receives Complete Response Letter For HTX-011 For The Management Of Postoperative Pain
Heron Therapeutics, Inc. (HRTX)
Last heron therapeutics, inc. earnings: 3/2 07:30 am
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Source: PR Newswire
SAN DIEGO, May 1, 2019 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on April 30, 2019 regarding its New Drug Application (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 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."We plan to request a meeting with the FDA to obtain its agreement on our approach to resolve the issues outlined in the CRL and resubmit the NDA as soon as possible," said Barry Quart,
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- 3/21/24 - Form 8-K
- 3/12/24 - Form 10-K
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