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Humanigen (HGEN) has announced positive interim Phase 3 data of lenzilumab in patients hospitalized with COVID-19. Shares are now popping 13% in Friday’s trading.
The clinical stage biopharma is focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead investigational treatment.
HGEN revealed that lenzilumab had a clinically meaningful impact on patient recovery, with an estimated 37% more recoveries observed in the lenzilumab arm of the randomized, placebo-controlled, double-blinded study versus current standard of care (SOC).
“These interim data demonstrate the potential of lenzilumab as a frontline treatment option for patients hospitalized with COVID-19,” said Cameron Durrant, CEO of Humanigen. “We are encouraged by these data and the clinically meaningful impact that lenzilumab may have for patients with COVID-19 over and above remdesivir and/or steroids.”
Following advice from the data safety monitoring board (DSMB), the company now plans to increase enrollment to approximately 515 patients. According to Humanigen, this will ensure a higher probability of success in meeting the primary endpoint and maintains the power of the study at 90%.
The next interim analysis for efficacy is planned when the study reaches 75% events (302 recoveries) which will require approximately 390 patients to be enrolled in the trial.
Humanigen intends to file for emergency use authorization in the US in the first quarter of 2021 either following interim data at 75% or at study completion. The Phase 3 trial evaluating patients hospitalized with COVID-19 is enrolling at sites across the U.S. and Latin America. Current enrollment stands at 300 patients.
Shares in HGEN have soared 409% year-to-date, and analysts currently have a unanimous Strong Buy consensus rating on the stock, based on 3 Buys and no Holds or Sells. At $27, the average analyst price target implies 116% upside potential.
H.C. Wainwright’s Joseph Pantginis recently initiated coverage of HGEN with a Buy rating and $31 price target (148% upside potential). Pantginis commented, “Lenzilumab’s development is furthest along in treating COVID-19 patients as the underlying mechanism has generated promising data in patients, to date, and is now in the league with the major players.”
“Looking well ahead into the future, even if the number of COVID-19 patients precipitously drops (hopefully), lenzilumab still needs to be available, because we still see a meaningful number of infections per year” he added. (See Humanigen stock analysis on TipRanks)
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