Shares of ChemoCentryx (CCXI) - Get Chemocentryx, Inc. Report jumped on Friday after the biopharma said it had received approval from the U.S. Food and Drug Administration for Tavneos, its ANCA-associated vasculitis therapy.
ANCA stands for anti-neutrophil cytoplasmic autoantibody.
Shares of the San Carlos, Calif., company at last check rose 64% to $32.14. The stock has traded on Friday up as much as 89% at $37. It touched a 52-week high above $70 in early February.
Tavneos, taken by mouth, is an adjunctive treatment for adult patients with severe cases of this rare autoimmune disease, the company said.
The drug will be available to clinicians and patients in the next few weeks, President and Chief Executive Thomas J. Schall said in a statement.
The company said this is the first new drug to treat ANCA vasculitis in a decade.
"This is an important step forward in the treatment of this disease,” Peter A. Merkel, the trial’s co-primary academic investigator and consultant to ChemCentryx, said in a statement.
ChemoCentryx researches orally administered small-molecule therapies for inflammatory diseases.
"Patients will now have access to a new class of medication that provides beneficial effects for the treatment of ANCA-associated vasculitis," Merkel added.
“There is a significant unmet need in the treatment of ANCA-associated vasculitis, with current therapies often leading to serious, even fatal, side effects and a diminished quality of life," Joyce Killman, executive director of the Vasculitis Foundation, said.
In October, the FDA approved ChemoCentryx's lead drug candidate, Avacopan, to treat a rare, fatal autoimmune disease.