Humanigen Announces Lenzilumab in COVID-19 Program Updates
Published: Oct 02, 2020
(
Please Note: This uploaded content is no longer available.)
Oct. 2, 2020 11:00 UTC
- Type B meeting with FDA provided feedback on Emergency Use Authorization submission plans
- Phase 3 trial expanded to Brazil with seven sites actively enrolling; patients already dosed
- 17 active trial sites in the US, including California, Texas and Florida
- Approval from Mexican regulatory agency to expand study in country with fourth highest reported deaths worldwide
- Top-line data planned for the fourth quarter of 2020
BURLINGAME, Calif.–(
BUSINESS WIRE)--
Humanigen, Inc. ,
(Nasdaq: HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate lenzilumab™, today announced updates on its lenzilumab in COVID-19 development program, including written guidance received from the
US Food and Drug Administration (FDA) following a Type B meeting to obtain feedback on plans for an Emergency Use Authorization (EUA). FDA agreed that the Company’s intended submission may be sufficient to support an EUA request, subject to Phase 3 trial data, and provided guidance and support for the Company’s Biologics License Application and approval pathway. . . .
