Rounding out a year of insider trading charges involving biopharma companies, the U.S. SEC reported Dec. 30 that it had filed a complaint against two top Humanigen Inc. executives, Cameron Durrant, CEO, and Dale Chappell, chief science officer, for trades based on insider knowledge of FDA actions.

While discussing positive data on its lead candidate lenzilumab for treating hospitalized COVID-19 patients, Humanigen Inc.’s CEO sparred a bit with the FDA and its refusal to grant the treatment emergency use authorization. The monoclonal antibody, Cameron Durrant told investors on a Dec. 2 call, could possibly have saved 60,000 to 70,000 patients while the company waits for another meeting with the FDA.

Initial efforts at Humanigen Inc. to win an FDA emergency use authorization (EUA) for treating hospitalized COVID-19 patients with its monoclonal antibody, lenzilumab, have failed to gain the regulator's buy-in, sending company shares (NASDAQ:HGEN) down 47.3% to $7.97 on Sept. 9 after touching a 52-week low during the session, a reaction part of a volatile arc that has seen shares climb as high as $29.20 during the same time span.

Shares of Humanigen Inc. (NASDAQ:HGEN) leapt 54.5% to $21.61 March 29 on news that its monoclonal antibody, lenzilumab, improved the relative likelihood of survival without mechanical ventilation in hospitalized patients with COVID-19, setting the company up to submit an application for emergency use authorization (EUA) in the U.S. "as soon as possible," it said. Separately, a combination of two monoclonal antibodies, the Eli Lilly and Co.-Abcellera Biologics Inc.-developed therapy bamlanivimab and the Vir Biotechnology Inc.-Glaxosmithkline plc candidate VIR-7831, demonstrated a 70% relative reduction in persistently high SARS-CoV-2 viral load at day seven compared to placebo for low-risk adult patients with mild to moderate COVID-19, the companies reported.

HONG KONG – Humanigen Inc. has executed its first licensing agreement in the Asia-Pacific region, in a deal worth up to $20 million that gives Telcon RF Pharmaceutical Inc. and KPM Tech Co. Ltd. the development and commercialization rights to lenzilumab for COVID-19 in South Korea and the Philippines.

Lenzilumab, the lead candidate from Humanigen Inc., has taken two large steps forward with positive interim phase III data and some support from the federal government. That, along with an Asia-Pacific region licensing from earlier in the week, has the relatively small company successfully “punching above our weight,” the CEO told BioWorld.

HONG KONG – Humanigen Inc. has executed its first licensing agreement in the Asia-Pacific region, in a deal worth up to $20 million that gives Telcon RF Pharmaceutical Inc. and KPM Tech Co. Ltd. the development and commercialization rights to lenzilumab for COVID-19 in South Korea and the Philippines.

Humanigen Inc. reported progress in COVID-19 treatment by deploying a drug candidate, lenzilumab, that was created to fight cytokine storms in CAR T patients. The drug is partnered for the latter with Gilead Sciences Inc., which rolled out pandemic news of its own related to the investigational broad-spectrum antiviral Veklury (remdesivir).