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Humanigen Shares Gain On FDA Emergency Filing Plans For COVID-19 Drug By June

Humanigen Shares Gain On FDA Emergency Filing Plans For COVID-19 Drug By June
  • Humanigen Inc (NASDAQ: HGEN) is prepping its COVID-19 drug lenzilumab for an emergency use authorization with the FDA before the month’s end.
  • According to its Q1 financial report out Thursday after-hours, the company said it had “recently held a meeting with FDA” to discuss the filing of a EUA for lenzilumab, specifically for hospitalized, hypoxic COVID-19 patients, “at the end of May.” It is also seeking a biologics license application for its drug in the same setting, though it may need more trials for full approval.
  • The EUA application comes after top-line data from its recent phase 3 that showed lenzilumab in hospitalized COVID-19 patients met its primary endpoint.
  • Humanigen said it has also been talking with U.K. drug regulator the Medicines and Healthcare Products Regulatory Agency and is plotting a rolling submission “before the end of the second quarter of 2021,” with similar plans for Europe.
  • The company reported a Q1 EPS loss of $(1.25) compared to a $(0.11) loss a year ago, primarily due to an increase in R&D of $59.2 million from $0.7 million.
  • The increase in R&D is principally due to an increase of $51.4 million in expense in lenzilumab manufacturing costs and $7.5 million for clinical trial expenses related to the LIVE-AIR study.
  • Price Actions: HGEN shares are trading 7.5% higher at $17.98 during the premarket session on the last check Friday

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