ChemoCentryx gains after filing amendment to application for Avocopan

Churchill Capital XI

06/07/2021 14:08

** Shares of biopharmaceutical company  CCXI.O  rise 13.5%
premarket to its one-month high at $14.85
    **  Co files an amendment to its New Drug Application for
avacopan for the treatment of Anti-neutrophil Cytoplasmic
Autoantibody (ANCA)-associated vasculitis  urn:newsml:reuters.com:*:nGNX3DrtrB
    ** The U.S. Food and Drug Administration (FDA) has indicated
that the filing constitutes a major amendment to the NDA and
will result in the setting of a new PDUFA goal date of October
7, 2021
    ** On May 6, the FDA Committee voted 9-9 on whether the
efficacy data support approval of avacopan
    ** FDA also voted 10-8 that the safety profile of avacopan
is adequate to support approval, and that the benefit-risk
profile is adequate to support approval of avacopan at the
proposed dose of 30 mg twice daily
    ** ANCA-associated vasculitis is a systemic disease leading
to inflammation and destruction of small blood vessels
    ** Up to Friday's close, stock has lost 78% of its value YTD

 (Reporting by Shashank Nayar in Bengaluru)
 ((Shashank.Nayar@thomsonreuters.com; within U.S. +1 646 223
8780; outside U.S. +91 80 6182 2256;))