Brief: Y-mAbs Announces Complete Response Letter For Omburtamab Biologics License Application

Y-mAbs Therapeutics

01/12/2022 22:47

Dec 1 (Reuters) - Y-mAbs Therapeutics Inc  YMAB.O :
    * Y-MABS ANNOUNCES COMPLETE RESPONSE LETTER FOR OMBURTAMAB
BIOLOGICS LICENSE APPLICATION
    * LETTER INDICATES THAT FDA COMPLETED REVIEW OF APPLICATION
AND
DETERMINED THAT IT IS UNABLE TO APPROVE BLA IN ITS CURRENT FORM
    * Y-MABS IS ASSESSING IMPLICATIONS OF CRL AND ITS PLANS FOR
OMBURTAMAB PROGRAM
    * CRL INCLUDES A RECOMMENDATION FOR MEETING WITH FDA
    * MEETING WITH FDA TO DISCUSS ADEQUATE, WELL-CONTROLLED
TRIAL
DESIGN TO SHOW SUBSTANTIAL EVIDENCE OF EFFECTIVENESS, FAVORABLE
BENEFIT-RISK PROFILE

Source text for Eikon:  ID:nGNX6LLrSq 
Further company coverage:  YMAB.O 
 ((Reuters.Briefs@thomsonreuters.com))