NEW YORK–(BUSINESS WIRE)–#Action–Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against Humanigen, Inc. (“Humanigen” or the “Company”) (NASDAQ: HGEN) in the United States District Court for the District of New Jersey on behalf of all persons and entities who purchased or otherwise acquired Humanigen securities between May 28, 2021 and July 12, 2022, both dates inclusive (the “Class Period”). Investors have until October 25, 2022 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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Humanigen is a clinical-stage biopharmaceutical company that focuses on preventing and treating an immune hyper-response called “cytokine storm”, a physiological reaction in which the immune system causes an uncontrolled and excessive release of pro-inflammatory signaling molecules called cytokines, the sudden release of which in large quantities can cause multisystem organ failure and death. The Company’s lead product candidate is its proprietary antibody lenzilumab, which is under development as a treatment for, among other things, cytokine storm associated with COVID-19.
Among other trials, Humanigen is investigating lenzilumab for the treatment of hospitalized COVID-19 patients in the ACTIV-5/BET-B study, which is part of a directed public-private partnership with the National Institutes of Health.
In May 2021, Humanigen submitted an application to the U.S. Food and Drug Administration (“FDA”) requesting Emergency Use Authorization (“EUA”) for lenzilumab for the treatment of patients hospitalized with COVID-19 (the “lenzilumab EUA”).
On September 9, 2021, Humanigen issued a press release announcing that the FDA had rejected the lenzilumab EUA, advising investors that, “[i]n its letter, [the] FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19.”
On this news, Humanigen’s stock price fell $7.14 per share, or 47.25%, to close at $7.97 per share on September 9, 2021.
Then, on July 13, 2022, Humanigen disclosed that lenzilumab had failed to show statistical significance on the primary endpoint of the ACTIV-5/BET-B study.
On this news, Humanigen’s stock price fell $2.38 per share, or 79.6%, to close at $0.61 per share on July 13, 2022.
The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) lenzilumab was less effective in treating hospitalized COVID-19 patients than 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.
If you purchased or otherwise acquired Humanigen shares and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Melissa Fortunato by email at email@example.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
About Bragar Eagel & Squire, P.C.:
Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.