WALTHAM, Mass., July 28, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (APLS) today announced that the U.S. Food and Drug Administration (FDA) has approved EMPAVELI ® (pegcetacoplan) as the ...

Apellis and Sobi's Aspaveli application for C3G and IC-MPGN treatment validated by the EMA, addressing rare kidney diseases. Apellis Pharmaceuticals and Sobi announced that the European Medicines ...

Credit: Apellis. Pegcetacoplan inhibits C3 activation by binding to C3 and its activation fragment C3b, thereby reducing C3 glomerular fragment deposition in patients with C3G and primary IC-MPGN.

Met the primary endpoint, achieving statistically significant 68% (p<0.0001) reduction in proteinuria compared to placebo in a broad study population Positive results consistent across all subgroups, ...

WALTHAM, Mass. and STOCKHOLM, June 06, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi® (STO:SOBI) today presented new data from the open-label period of the Phase 3 ...

Full-year 2025 net product revenues of $689 millionSYFOVRE® (pegcetacoplan injection) full year 2025 net product revenue of $587 millionEMPAVELI® ...

The change in proteinuria was significantly greater with pegcetacoplan than placebo, representing a 68.1% relative reduction vs placebo. HealthDay News — Among patients with C3 glomerulopathy or ...

An ultra-rare kidney disease that can become life-threatening now has its first FDA-approved therapy. The affirmative regulatory decision is the third for Novartis’s Fabhalta, building up the drug’s ...

The Food and Drug Administration (FDA) has granted Priority Review to pegcetacoplan for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC ...

The U.S. Food and Drug Administration (FDA) on Tuesday accepted and granted Priority Review designation to Apellis Pharmaceuticals, Inc.’s (NASDAQ:APLS) supplemental New Drug Application (sNDA) for ...