Brief: Histogen Reports FDA Clinical Hold For Planned Phase 1/2 Trial Of HST-003

Histogen

19/01/2021 21:16

Jan 19 (Reuters) - Histogen Inc  HSTO.O :
    * HISTOGEN REPORTS FDA CLINICAL HOLD FOR PLANNED PHASE 1/2
TRIAL
OF HST-003 FOR KNEE CARTILAGE REGENERATION
    * HISTOGEN- HISTOGEN HAS NOT YET RECEIVED WRITTEN NOTICE OF
ITS
CLINICAL HOLD FROM FDA, WHICH FDA EXPECTS TO PROVIDE TO COMPANY
BY FEBRUARY 12, 2021
    * HISTOGEN INC - BASED UPON VERBAL COMMUNICATION WITH FDA,
INDICATED THAT CLINICAL HOLD IS DUE TO PENDING CMC INFORMATION
REQUIRED TO COMPLETE REVIEW
    * HISTOGEN INC -  PLANS TO PROVIDE UPDATED GUIDANCE ON ANY
POTENTIAL IMPACT TO HST-003 PROGRAM ONCE WRITTEN NOTICE FROM FDA
IS RECEIVED

Source text for Eikon:  ID:nGNX4J3qJ2 
Further company coverage:  HSTO.O 

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