HGEN - Humanigen +11% on positive lenzilumab data in COVID-19
Humanigen (HGEN) perks 11% after announcing positive interim Phase 3 data of lenzilumab in patients hospitalized with COVID-19.Lenzilumab had a clinically meaningful impact on patient recovery, with an estimated 37% more recoveries observed in the lenzilumab arm (HR of 1.37) vs. current standard of care (SoC).The data safety monitoring board ((DSMB)) recommended increasing the target number of events (recoveries) from 257 to 402 to maintain the power of the study at 90%.The company plans to increase enrollment to achieve 402 events (~515 patients) which will ensure an even 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 events) which will require ~390 patients to be enrolled in the trial.Humanigen intends to file for EUA in Q1 2021 either following interim data at 75% or at study completion.Also, HGEN and and
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Humanigen +11% on positive lenzilumab data in COVID-19