ChemoCentryx (CCXI) Closes Up 7% on Filing of Amendment to NDA Submission and Extension of PDUFA for Avacopan

ChemoCentryx, Inc., (NASDAQ: CCXI) shares gained nearly 7% Tuesday following an announcement that the company filed an amendment to its New Drug Application (NDA) for avacopan for the treatment of Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated vasculitis.

CCXI shares took a hit in early May when the company announced mixed results of its meeting with FDA Arthritis Advisory Committee – the AdCom voted 9-9 on whether the efficacy data supports approval of avacopan, 10-8 that the safety profile of avacopan is adequate to support approval, and 10-8 that the benefit-risk profile is adequate to support approval of avacopan at the proposed dose of 30 mg twice daily.

The FDA has accepted an amendment to the original NDA filing in which the company seeks to address concerns raised by the Committee and set a new PDUFA goal date of October 7th, 2021.

Raymond James analyst Steven Seedhouse views the announcement as positive: “A three-month extension to the PDUFA date for avacopan in ANCA vasculitis is not totally unexpected but supports our view that approval by the new PDUFA date of 10/7/2021 is 50/50 odds. The market was pricing in closer to 10% probability-of-approval based on our model. We think the Street will recognize this is a positive development and price CCXI more accurately into the new PDUFA to reflect 50/50 odds of approval.”

The analyst maintains an “Outperform” rating on the shares.

Written by Vlad Schepkov [email protected]

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