Brief: Humanigen Inc - Met With Senior Staff Of FDA In A Type B Meeting Regarding Lenzilumab For The Treatment Of COVID-19

Humanigen

05/01/2022 11:25

Jan 5 (Reuters) - Humanigen Inc  HGEN.O :
    * HUMANIGEN INC -  MET WITH SENIOR STAFF OF FDA IN A TYPE B
MEETING REGARDING LENZILUMAB FOR THE TREATMENT OF COVID-19
    * HUMANIGEN INC - WILL INCLUDE RESULTS FROM ACTIV-5/BET-B
STUDY,
IF POSITIVE & CONFIRMATORY OF RESULTS GENERATED BY LIVE-AIR
STUDY, IN AMENDMENT TO EUA
    * HUMANIGEN - RECEIVED RESPONSE FROM MHRA TO SUBMISSION OF
LENZILUMAB FOR MARKETING AUTHORIZATION & HELD CLARIFYING
DISCUSSIONS WITH MHRA REPRESENTATIVES
    * HUMANIGEN INC - MHRA RESPONSE INCLUDED SEVERAL REQUESTS
FOR
FURTHER INFORMATION RELATED TO CLINICAL, MANUFACTURING AND
QUALITY PROCESSES.
    * HUMANIGEN INC -  BELIEVES IT CAN RESPOND TO A MAJORITY OF
THE
REQUESTS IN THE FIRST QUARTER OF 2022
    * HUMANIGEN INC - DUE TO FEEDBACK FROM EMA, INTENDS TO
SUBMIT A
CONDITIONAL MARKETING AUTHORIZATION FOR LENZILUMAB WITH AN
ACCELERATED APPROVAL REQUEST


Further company coverage:  HGEN.O 

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