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Heron Therapeutics, Inc.

Company NameHeron Therapeutics, Inc.
Stock SymbolHRTX
Class PeriodOctober 31, 2018 to April 30, 2019
Lead Plaintiff Motion DeadlineAugust 05, 2019

On May 1, 2019, the Company confirmed receipt of a Complete Response Letter from the FDA in which the FDA was unable to approve the Company’s New Drug Application for a new postoperative pain medication it had been developing, due to the need for additional information.

On this news, shares of Heron Therapeutics fell $3.93 per share, or over 18%, to close at $17.75 on May 1, 2019, thereby injuring investors.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) the Company had failed to include adequate Chemistry, Manufacturing, and Controls and non-clinical information in its New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for HTX-011; (2) the foregoing increased the likelihood that the FDA would not approve the Company’s NDA for HTX-011; and (3) as a result, defendants’ public statements were materially false and/or misleading at all relevant times.

 

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