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Investing.com -- Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) stock surged 12% after the U.S. Food and Drug Administration (FDA) approved EMPAVELI® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years and older.
The approval marks a significant milestone for patients with these rare kidney diseases, which affect approximately 5,000 people in the United States and often lead to kidney failure. EMPAVELI demonstrated impressive efficacy in the Phase 3 VALIANT study, showing a 68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3 deposits compared to placebo.
"I’m excited to now have a highly effective therapy for a broad range of patients living with C3G and primary IC-MPGN," said Carla Nester, lead principal investigator for the VALIANT study and professor at the University of Iowa Stead Family Children’s Hospital.
The FDA approval includes a broad label covering adults and adolescents with C3G or primary IC-MPGN, as well as post-transplant C3G disease recurrence. This represents Apellis’ third FDA approval in four years, highlighting the company’s focus on targeting C3 to treat rare diseases.
EMPAVELI’s safety profile is well-established across more than 2,200 patient years in approved indications. The most common adverse reactions in the VALIANT study included infusion site reactions, fever, nasopharyngitis, influenza, cough, and nausea.
Apellis has established the ApellisAssist® program to support patients with treatment access, insurance navigation, and financial assistance for eligible individuals.
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