HGEN - Humanigen provides update on its late-stage lenzilumab study in COVID-19

Following a type B meeting with the FDA, Humanigen (HGEN) said that the agency has agreed with its current intended submission of lenzilumab in COVID-19 may be sufficient to support an Emergency Use Authorization ((EUA)) request, subject to Phase 3 trial data.The FDA said no material changes are required on Chemistry, Manufacturing and Controls plan, EUA labeling and the Statistical Analysis Plan.The company also announced that lenzilumab Phase 3 trials have been expanded to Brazil and Mexico.Top-line data expected by end of this year.Shares are up 4.2% in premarket.

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Humanigen provides update on its late-stage lenzilumab study in COVID-19