November 21, 2019 - The case was voluntarily dismissed.
June 5, 2019 - An investor in shares of Heron Therapeutics, Inc. (NASDAQ: HRTX) filed a lawsuit in the U.S. District Court for the Southern District of California over alleged violations of Federal Securities Laws by Heron Therapeutics, Inc. in connection with certain allegedly false and misleading statements made between October 31, 2018 and April 30, 2019.
San Diego, CA based Heron Therapeutics, Inc., a biotechnology company, engages in developing treatments to address unmet medical needs. On October 31, 2018, Heron Therapeutics, Inc announced the submission of its New Drug Application (“NDA”) for HTX-011 to the U.S. Food and Drug Administration (“FDA”) for postoperative pain management.
On February 22, 2019, Heron Therapeutics, Inc announced its financial results for the fourth quarter and full year 2018. Heron Therapeutics, Inc. reported that its annual Total Revenue rose from $30.76 million in 2017 to $77.47 million in 2018 and that its Net Loss declined from $197.48 million in 2017 to $178.84 million in 2018. Heron Therapeutics, Inc also stated that the U.S. Food and Drug Administration (FDA) accepted the new drug application (NDA) for Heron's investigational agent, HTX-011, and has granted it a Priority Review designation. Heron Therapeutics, Inc also said that the FDA set a Prescription Drug User Fee Act (PDUFA) goal date of April 30, 2019 and indicated that it is not currently planning an advisory committee meeting to discuss this application.
Then, on May 1, 2019, Heron Therapeutics, Inc announced receipt of a Complete Response Letter (“CRL”) from the FDA on April 30, 2019, regarding Heron’s NDA for HTX-011 for the management of postoperative pain (the “May 2019 Press Release”). In the May 2019 announcement, Heron Therapeutics, Inc 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 CMC and non-clinical information.”
Shares of Heron Therapeutics, Inc. (NASDAQ: HRTX) declined from $42.00 per share in June 2018 to as low as $16.97 per share on May 31, 2019.
According to the complaint the plaintiff alleges on behalf of purchasers of Heron Therapeutics, Inc. (NASDAQ: HRTX) common shares between October 31, 2018 and April 30, 2019, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between October 31, 2018 and April 30, 2019, the Defendants made false and/or misleading statements and/or failed to disclose that Heron had failed to include adequate Chemistry, Manufacturing, and Controls (“CMC”) and non-clinical information in its NDA for HTX-011, that the foregoing increased the likelihood that the FDA would not approve Heron’s NDA for HTX-011, and that as a result, Heron’s public statements were materially false and misleading at all relevant times.