BioXcel Therapeutics, Inc. (BTAI)
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.
Investigation
07/13/2022
Initial Lawsuit
08/26/2022
Lawsuit Progression
10/25/2022
Did Humanigen mislead investors regarding the emergency use authorization (EUA) for lenzilumab and its ability to achieve statistical significance in the trial evaluating lenzilumab plus remdesivir versus placebo plus remdesivir in hospitalized COVID-19 patients?
This post is open for investors to gather facts, findings and track their exposure to related lawsuits. We invite investors and shareholders to contribute to this investigation for their own benefit, add events to the factual timeline below and vote on events’ pertinence.
A lawsuit was subsequently filed. We update this post regularly.
07/12/2022
Humanigen announces the preliminary topline results from the National Institute of Allergy and Infectious Diseases’ (NIAID) ACTIV-5/BET-B trial evaluating lenzilumab plus remdesivir versus placebo plus remdesivir in hospitalized COVID-19 patients.
“The trial did not achieve statistical significance on the primary endpoint, which was defined as the proportion of patients with baseline CRP<150 mg/L and age<85 years, alive and without mechanical ventilation through Day 29. The data also showed a non-significant trend toward a reduction in mortality in the overall patient population [HR 0.72]. There were no new safety signals attributed to lenzilumab in the ACTIV-5/BET-B study.“
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$0.61 | $2.99 | $-2.38 | -79.6% |
A Humanigen, Inc. (HGEN) filed a federal securities class action lawsuit on behalf of a class consisting of all persons and entities other than the defendants that purchased or otherwise acquired Humanigen securities between May 28, 2021, and July 12, 2022, both dates 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) lenzilumab was less effective in treating hospitalized COVID-19patients than the defendants had represented;
(ii) as a result, the FDA was unlikely to approve the lenzilumab EUA and the ACTIV-5/BET-B study was unlikely to meet its primary endpoint;
(iii) accordingly, lenzilumab’s clinical and commercial prospects were overstated; and
(iv) as a result, the company’s public statements were materially false and misleading at all relevant times.
The lead plaintiff deadline has passed, we will update this page as the lawsuit progresses
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.