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 s it did in previous studies.

On this news, Humanigen’s stock price fell by 79.6%.

Back on September 9, 2021, Humanigen issued a press release announcing that the FDA had rejected the lenzilumab EUA, advising investors that, “in 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.

Thus, there are grounds to suspect that the Company was not disclosed in a proper way that lenzilumab was less effective in treating hospitalized COVID-19 patients, the FDA was unlikely to approve the lenzilumab and, as a result, the Company overstated lenzilumab’s clinical and commercial prospects.