Apellis reports positive 18-month Phase 3 data for pegcetacoplan in GA; NDA planned Q2 2022

Apellis Pharmaceuticals, Inc.

OAKS GA: monthly pegcetacoplan reduced lesion growth 22% (p<0.0001); every-other-month 16% (p=0.0018) at month 18.
DERBY GA: monthly reduction 13% (p=0.0254); every-other-month 12% (p=0.0332); effects improved vs months 0-6.
Combined: monthly reduction improved from 13% (months 0-6) to 21% (months 12-18); every-other-month from 12% to 17%.
Safety: endophthalmitis rate 0.044% per injection; intraocular inflammation 0.23%; no retinal vasculitis or vein occlusion.
Company plans to submit NDA to FDA for intravitreal pegcetacoplan in GA in Q2 2022.

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