Pomerantz Appointed Co-Lead Counsel in Humanigen Securities Litigation

On December 9, 2022, U.S. Magistrate Judge André M. Espinosa, of the District of New Jersey, appointed Pomerantz LLP as Co-Lead Counsel on behalf of its client, Joshua Mailey, who serves as the Co-Lead Plaintiff, and the class, in In re Humanigen, Inc. Sec. Litig., 22-cv-5258 (D.N.J.). This securities action alleges that Humanigen, Inc. (“Humanigen” or the “Company”) misled the market regarding the regulatory and commercial prospects for lenzilumab – its lead product candidate an antibody treatment for cytokine storm (an auto-immune response triggered by infection that results in the overproduction of inflammatory proteins in the bloodstream).

Humanigen is a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cytokine storm. In May 2021, Humanigen announced it had submitted a request to the U.S. Food and Drug Administration (“FDA”) for emergency use authorization (“EUA”) of lenzilumab as a treatment for cytokine storm.

Allegations against Humanigen include that: (i) lenzilumab had less success in treating hospitalized COVID-19 patients than defendants had previously claimed; (ii) accordingly, the treatment was unlikely to be approved for emergency use by the FDA; and (iii) as a result, the clinical and commercial prospects of lenzilumab had been overstated.

In May 2021, Humanigen begam touting the positive results of lenzilumab’s trial studies. The Company also affirmed its belief that the trials would “provide the sufficient size and statistical power typically required for a [Biologics License Application (‘BLA’)] to be submitted to FDA.” In August 2021, Humanigen stated that it remained “firm in [its] belief” that the results of lenzilumab’s trials would warrant it being granted an EUA.

The truth began to emerge on September 9, 2021, when Humanigen announced that lenzilumab’s EUA had been rejected by the FDA. On this news, the Company’s share price fell by over 47%. 

Then, on July 13, 2022, Humanigen disclosed that lenzilumab’s study intended to test the efficacy of the drug for patients hospitalized with COVID-19 had failed to show statistical significance. On this news, the Company’s share price fell by approximately 80%.