Heron Therapeutics, Inc.
- Company Name
- Heron Therapeutics, Inc.
- Stock Symbol
- Class Period
- October 31, 2018 to April 30, 2019
- Motion Deadline
- August 3, 2019
- Southern District of California
The complaint charges Heron and certain of its officers with violations of the Securities Exchange Act of 1934. Heron is a biotechnology company that develops treatments to address unmet medical needs.
Heron is developing HTX-011, an investigational long-acting and extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for post-operative pain management. On October 31, 2018, Heron 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.
The complaint alleges that throughout the Class Period, defendants made materially false and misleading statements and/or failed to disclose adverse information regarding the Company’s business and prospects. Specifically, defendants 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, which increased the likelihood that the FDA would not approve Heron’s NDA for HTX-011. As a result of this information being withheld from the market, Heron securities traded at artificially inflated prices of more than $30 per share during the Class Period.
Then on May 1, 2019, Heron announced that on April 30, 2019 it had received a Complete Response Letter (“CRL”) from the FDA regarding Heron’s NDA for HTX-011. According to the press release, Heron’s NDA for HTX-011 for post-operative pain management had failed to gain FDA approval because it lacked sufficient information. Specifically, the press release 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.” In addition, the press release asserted that, “[b]ased 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 of data analysis.” Thus, the FDA had denied the NDA solely based on Heron’s failure to include the requisite CMC and non-clinical information in the NDA. On this news, Heron’s stock price fell $3.93 per share, or more than 18%, to close at $17.75 per share on May 1, 2019.