ChemoCentryx Inc

NASDAQ:CCXI   3:59:50 PM EDT
14.39
-0.60 (-4.00%)
: $14.00 -0.39 (-2.71%)
Regulatory, Earnings Announcements

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

Published: 07/06/2021 12:57 GMT
ChemoCentryx Inc (CCXI) - 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.
Revenue is expected to be $4.85 Million
Adjusted EPS is expected to be -$0.55

Next Quarter Revenue Guidance is expected to be $10.11 Million
Next Quarter EPS Guidance is expected to be -$0.52

More details on our Analysts Page.