Brief: US FDA Issues Complete Response Letter For Cosibelimab

Checkpoint Therapeutics

18/12/2023 12:07

Dec 18 (Reuters) - Checkpoint Therapeutics Inc  CKPT.O :
    * U.S. FOOD AND DRUG ADMINISTRATION ISSUES COMPLETE RESPONSE
LETTER FOR COSIBELIMAB SOLELY DUE TO INSPECTION FINDINGS AT
THIRD-PARTY MANUFACTURER
    * CHECKPOINT THERAPEUTICS INC - CRL DID NOT STATE ANY
CONCERNS
ABOUT CLINICAL DATA PACKAGE, SAFETY, OR LABELING FOR
APPROVABILITY OF COSIBELIMAB.
    * CHECKPOINT THERAPEUTICS INC - CAN ADDRESS FEEDBACK IN A
RESUBMISSION TO ENABLE MARKETING APPROVAL IN 2024
    * CHECKPOINT: CRL CITES FINDINGS FROM MULTI-SPONSOR
INSPECTION OF
THIRD-PARTY CONTRACT MANUFACTURING ORGANIZATION AS APPROVABILITY
ISSUES TO ADDRESS IN RESUBMISSION

Source text for Eikon:  ID:nGNXn11Lr 
Further company coverage:  CKPT.O 

 ((Reuters.Briefs@thomsonreuters.com;))