We are investigating Heron Therapeutics, Inc. (HRTX) (“Heron” or the “Company”) for potential violations of the federal securities laws.
On May 1, 2019, Heron announced receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) on April 30, 2019 regarding Heron’s New Drug Application (“NDA”) for HTX-011 for the management of postoperative pain. Heron advised investors that “[t]he CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional [Chemistry, Manufacturing, and Controls] and non-clinical information.” On this news, Heron’s stock price fell $3.93 per share, or 18.13%, to close at $17.75 per share on May 1, 2019.