ChemoCentryx Shares Rise 10% After Filing NDA Amendment for Avacopan
July 06 2021 - 1:19PM
Dow Jones News
By Chris Wack
ChemoCentryx Inc. shares were up 10% at $14.52 after the company
said that, following consultations with the U.S. Food and Drug
Administration, it filed an amendment to its New Drug Application
for avacopan for the treatment of anti-neutrophil cytoplasmic
autoantibody-associated vasculitis.
The company said the amendment addresses points raised during an
FDA Advisory Committee meeting on May 6.
The FDA has indicated that the filing constitutes a major
amendment to the NDA and will result in the setting of a new
Prescription Drug User Fee Act goal date of Oct. 7. The NDA is
primarily based on data from a Phase III trial of avacopan for the
treatment of ANCA-associated vasculitis.
On May 6, the FDA's Arthritis Advisory Committee voted 9-9 on
whether the efficacy data support 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 Marketing Authorization Application for avacopan in the
treatment of ANCA-associated vasculitis was validated by the
European Medicines Agency in November 2020, and the Japanese New
Drug Application was accepted for review by the Japanese
Pharmaceuticals and Medical Device Agency in February.
Volume for the stock was 9 million shares at 12:45 p.m. ET,
compared with its 65-day average volume of 3.6 million shares. The
stock hit its 52-week low of $9.53 on May 25.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
July 06, 2021 13:05 ET (17:05 GMT)
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