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Tuesday, July 29, 2025

FDA Approves Apellis’ EMPAVELI® (pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment

 

  • Proven efficacy across all three key markers of disease—68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3 deposits

  • Broad label includes adults and adolescents with C3G or primary IC-MPGN, and post-transplant C3G disease recurrence

  • Well-established safety profile, consistent across >2,200 patient years in approved indications

  • C3G and primary IC-MPGN are rare kidney diseases with high risk of kidney failure

  • Conference call tomorrow at 8:00 a.m. ET

Conference Call and Webcast
Apellis will host a conference call and webcast to discuss the FDA’s approval of EMPAVELI tomorrow, July 29, 2025 at 8:00 a.m. ET. To access the live call by phone, please pre-register for the call here. A live audio webcast of the event and accompanying slides may also be accessed through the “Events and Presentations” page of the “Investors and Media” section of the company’s website. A replay of the webcast will be available for 30 days following the event.

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