Potential breakthrough coronavirus treatment

Potential breakthrough coronavirus treatment

Oct. 03, 2020 - 2:47 - Humanigen Chairman and CEO Dr. Cameron Durrant joins ‘Tucker Carlson Tonight.’

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Humanigen Announces Lenzilumab in COVID-19 Program Updates

Published: Oct 02, 2020

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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. . . .

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