Heron Therapeutics, Inc. (HRTX) Accused of Misleading Investors

According to the complaint for alleged violations of the Securities Exchange Act of 1934 between October 31, 2018 and April 30, 2019, in October 2018, Heron Therapeutics, Inc. (HRTX) announced the submission of its New Drug Application ("NDA") for HTX-011 to the U.S. Food and Drug Administration ("FDA") for post-operative pain management. It touted the data it used to support the filing. Heron's CEO went further by promoting Heron's prior experience with filing NDAs, as well as its close working relationship with the FDA. However, Heron failed to disclose that the HTX-011 NDA did not contain adequate information. In May 2019, Heron revealed that HTX-011 had failed to gain FDA approval because it lacked sufficient information. Specifically, the FDA denied HTX-011's NDA purely based on Heron's failure to include the requisite CMC and non-clinical information. On this news, Heron's stock price fell over 18% to close at $17.75 per share on May 1, 2019, and has yet to recover.