Humanigen, Inc. (HGEN) Overstated the Clinical and Commercial Prospects of its Lead Drug Candidate
A shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired Humanigen, Inc. (NASDAQ: HGEN) securities between May 28, 2021 and July 12, 2022, for violations of the Securities Exchange Act of 1934. Humanigen is a clinical-stage biopharmaceutical company that focuses on preventing and treating an immune hyper-response called “cytokine storm,” which can result in organ failure and death. The Company’s lead product candidate is proprietary antibody lenzilumab, which is under development as a treatment for, among other things, cytokine storm associated with COVID-19.
In May 2021, Humanigen submitted an application to the U.S. Food and Drug Administration requesting Emergency Use Authorization (“EUA”) for lenzilumab for the treatment of patients hospitalized with COVID-19.
On September 9, 2021, Humanigen announced that the FDA had rejected the lenzilumab EUA, advising 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 over 47%, 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 fell almost 80%, to close at $0.61 per share on July 13, 2022.
During the class period, defendants failed to disclose that lenzilumab was less effective in treating hospitalized COVID-19 patients than defendants had represented. 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.
Next Steps: If you acquired shares of Humanigen, Inc. (HGEN) between May 28, 2021 and July 12, 2022, you have until October 25, 2022, to ask the court to appoint you lead plaintiff for the class. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
