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Apellis Pharmaceuticals (APLS) investor relations material
Apellis Pharmaceuticals Baird Global Healthcare Conference 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Company overview and recent achievements
Focus on complement pathways, especially C3, with three approved products targeting rare diseases and geographic atrophy.
EMPAVELI approved for PNH (2021), geographic atrophy (2023), and recently for C3 glomerulopathy and ICMPGN.
Phase 3 trials ongoing for additional kidney indications: focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF).
Advancing preclinical pipeline, including a gene editing program targeting the neonatal FC gamma receptor.
EMPAVELI launch and market positioning
Valiant trial showed strong efficacy across all patient groups, including adults, pediatrics, pre- and post-transplant.
EMPAVELI offers best-in-class potential with broad label and practical subcutaneous administration via Enable injector.
Early launch progressing as expected, with patient starts and payer interactions on track; bolus of early access and extension study patients expected to transition to commercial product.
Targeting broad C3G and ICMPGN populations, aiming to reduce reliance on immunosuppressants and improve quality of life.
Additional data from extension studies will inform long-term efficacy and safety.
Pipeline expansion and clinical development
FSGS and DGF selected for phase 3 trials due to strong target engagement and unmet need; both trials to start before year-end.
DGF affects 7,000–10,000 patients annually in the U.S., with treatment planned for three months.
FSGS is a continuous therapy, with trial design details pending regulatory developments.
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