Investigation
BioXcel Therapeutics, Inc. (BTAI)
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.
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Investigation
08/03/2022
Initial Lawsuit
08/17/2022
Lawsuit Progression
10/17/2022
An Ampio Pharmaceuticals, Inc. (AMPE) investor filed a securities class action lawsuit on behalf of all persons or entities that purchased or otherwise acquired Ampio common stock between December 29, 2020, and August 3, 2022, inclusive.
According to the complaint, 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 allegedly failed to disclose to investors that:
(i) inflated the company’s true ability to successfully file a BLA for Ampion;
(ii) inflated the results of the AP-013 study and the timing of unblinding the data from the AP-013 study; and
(iii) that, as a result, of the foregoing, the defendants’ statements about the company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
Excerpt
“Through various filings with the SEC, Ampio claims to have developed Ampion®, its lead product with “unique immunomodulatory action and anti-inflammatory effects” used to treat individuals with inflammatory conditions including, but not limited to, severe osteoarthritis of the knee (“OAK”). The Company further asserts that “Ampion is currently in development as an intra-articular injection treatment for severe OAK, an intravenous and inhaled treatment for hospitalized severe and/or critical COVID-19 patients, and an at-home inhalation treatment for patients with prolonged respiratory symptoms due to COVID-19, commonly referred to as “LongCOVID.”
Beginning in 2010 and lasting through approximately March 2022, Ampio conducted numerous clinical trials and analyses to determine Ampion’s efficacy. Despite confidently advertising on numerous occasions that Ampion demonstrated a statistically significant decrease in pain associated in symptomatic moderate-severe OAK, the Company failed to bring Ampion to market.
After months of delay and analyst speculation of the effectiveness of Ampion, on May 16, 2022, the Company announced that it had formed a special committee of the Ampio Board of Directors (the “Board”) was conducting internal investigations focusing specifically on the statistical analysis of Ampio’s AP-013 clinical trial and unauthorized provision of Ampion which had not yet been approved by the U.S. Food and Drug Administration (“FDA”).
Then, in premarket hours on August 3, 2022, Ampio issued a press release containing a letter to stockholders revealing that the Individual Defendants (as defined herein) “and senior staff were aware, at the time of the per-protocol interim analysis in March 2020, 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.” On this news, the Company’s share price dropped $0.06, or 35.38%, from the previous day’s close, on greater than usual trading volume.”
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.