Brief: ChemoCentryx Reports Filing of Amendment to NDA Submission and Extension of PDUFA Review Period for Avacopan

Churchill Capital XI

06/07/2021 13:51

July 6 (Reuters) - ChemoCentryx Inc  CCXI.O :
    * CHEMOCENTRYX ANNOUNCES FILING OF AMENDMENT TO NDA
SUBMISSION AND
EXTENSION OF THE PDUFA REVIEW PERIOD FOR AVACOPAN IN THE
TREATMENT OF ANCA-ASSOCIATED VASCULITIS
    * CHEMOCENTRYX INC - FDA HAS INDICATED FILING CONSTITUTES A
MAJOR
AMENDMENT TO NDA AND WILL RESULT IN SETTING OF A NEW PDUFA GOAL
DATE OF OCTOBER 7
    * CHEMOCENTRYX - ON MAY 6, FDA'S ARTHRITIS ADVISORY
COMMITTEE
VOTED 9-9 ON WHETHER EFFICACY DATA SUPPORT APPROVAL OF AVACOPAN
    * CHEMOCENTRYX - FDA'S ARTHRITIS ADVISORY COMMITTEE VOTED
10-8
BENEFIT-RISK PROFILE IS ADEQUATE TO SUPPORT APPROVAL OF AVACOPAN
AT PROPOSED DOSE

Source text for Eikon:  ID:nGNX3DrtrB 
Further company coverage:  CCXI.O 

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