EMPAVELI Priority Review and Phase 3 Success
EMPAVELI received Priority Review designation from the FDA for C3G and IC-MPGN with a PDUFA date of July 28. The Phase 3 VALIANT results showed a 68% reduction in proteinuria, stabilization of kidney function, and substantial clearing of C3c staining.
SYFOVRE Market Leadership
SYFOVRE maintains over 60% market share in geographic atrophy with new patient starts exceeding 50% in Q1 2025 and reaching 55% by late April.
Financial Stability
Apellis has $358 million in cash and cash equivalents, expecting this to be sufficient to fund the business to profitability.
EMPAVELI Blockbuster Potential
U.S. launch of EMPAVELI in C3G and IC-MPGN expected to represent Apellis' third new product launch in four years, expanding presence in rare nephrology indications.