(Humanigen) US Food and Drug Administration has declined to grant an emergency use authorization for Humanigen’s Lenzilumab for use by hospitalized Covid-19 patients.
FDA says it is unable to conclusively determine the known and potential benefits of lenzilumab, against the potential risks for use in Covid treatment.
Humanigen expects the ongoing ACTIV-5/BET-B study to provide additional data that will boost FDA’s approval in a new EUA request.
The company says it remains committed to finalizing the regulatory process for lenzilumab authorization in the UK and other countries.
HGEN: NASDAQ is down -52.42% on premarket.
