Shares of ChemoCentryx (CCXI) - Get Chemocentryx, Inc. Report were higher after the clinical-stage biopharma, following consultations with the Food and Drug Administration, amended its new-drug application for avacopan to treat vasculitis.
The amendment addresses points that an FDA advisory committee brought up during a May 6 meeting about the drug.
The San Carlos, Calif., company gave the FDA additional data and information that "addresses many of the issues raised at the advisory committee meeting,” said Thomas J. Schall, president and chief executive, said in a statement. “We look forward to continuing discussions with the agency.”
Shares of ChemoCentryx at last check jumped 6.4% to $14.02.
The FDA has set a new PDUFA goal date -- the date by which the agency must complete its review of the drug -- of Oct. 7. The Prescription Drug User Fee Act, passed in 1992, authorized the FDA to collect fees from companies that produce certain human drug and biological products.
In May, ChemoCentryx dropped more than 60% after an FDA panel gave mixed support to the biotech's experimental autoimmune drug, prompting analysts to slash their ratings and price targets.
The company said that the FDA's Arthritis Advisory Committee had voted 10-8 that the safety profile of ChemoCentryx's avacopan was adequate to support approval of the drug to treat adult patients with AAV, a rare autoimmune disease.
The committee was split 9-9 on whether the efficacy data supported approval of avacopan to treat adult patients with AAV.