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Ampio Pharmaceuticals, Inc.

Company NameAmpio Pharmaceuticals, Inc.
Stock SymbolAMPE
Class PeriodDecember 29, 2020 to August 03, 2022
Lead Plaintiff Motion DeadlineOctober 17, 2022

On April 20, 2022, Ampio announced that the U.S. Food and Drug Administration (“FDA”) responded negatively to its Type C meeting request for the Company’s AP-013 clinical trial and that the FDA found the Company should have sought the FDA’s agreement on changes to the data analysis prior to analyzing and unblinding the data. On this news, the Company’s share price fell $0.09, or 26%, to close at $0.25 per share on April 21, 2022.

Then, on May 16, 2022, Ampio announced that it had formed a special committee to conduct an internal investigation focusing on Ampio’s AP-013 clinical trial and unauthorized provision of its anti-inflammatory drug Ampion for use by individuals not participating in clinical trials. On this news, the Company’s share price fell $0.04, or 10%, to close at $0.18 per share on May 18, 2022.

Then, on August 3, 2022, Ampio disclosed that, as far back as March 2020, “senior staff were aware . . . that the AP-013 trial did not demonstrate efficacy for Ampion on its co-primary endpoints of pain and function; and that these persons did not fully report the results of the AP-013 trial and the timing of unblinding of data from the AP-013 trial." The Company also revealed "that certain Ampio personnel, including a former executive officer and certain former directors, facilitated the provision of Ampion for unauthorized use."

On this news, Ampio’s stock fell $0.06, or 37.5%, to close at $0.10 per share on August 3, 2022, 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: (1) inflated the Company's true ability to successfully file a Biologics License Application for Ampion; (2) inflated the results of the AP-013 study and the timing of unblinding the data from the AP-013 study; and (3) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.

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