Three-year data supports extended treatment of Syfovre for GA
Research

Three-year data supports extended treatment of Syfovre for GA

Phase 3 GALE study results indicate a continued reduction in GA lesion growth.
Positive 24-month data released for phase 3 trials on Syfovre
Products

Positive 24-month data released for phase 3 trials on Syfovre

Latest data supports the FDA-approved therapeutic for treating GA.
CMS assigns Syfovre a permanent J-code
Products

CMS assigns Syfovre a permanent J-code

Formulation is the first and only treatment FDA-approved for geographic atrophy secondary to AMD.
Apellis to reduce workforce in support of Syfovre growth, prioritize research initiatives
Business

Apellis to reduce workforce in support of Syfovre growth, prioritize research initiatives

Company details plans for Syfovre and systemic pegcetacoplan, with a focus on novel therapies for retina and central nervous system diseases.
Apellis reports update on Syfovre-associated retinal vasculitis cases
Products

Apellis reports update on Syfovre-associated retinal vasculitis cases

Company is also notifying clinicians to discontinue use of 19-gauge filter needles included in certain injection kits.
Extension study reinforces Syfovre long-term efficacy for GA
Products

Extension study reinforces Syfovre long-term efficacy for GA

Thirty-month data supports the FDA-approved drug’s use for GA patients.
Apellis releases update on review of Syfovre retinal vasculitis cases
Products

Apellis releases update on review of Syfovre retinal vasculitis cases

Company reports findings from ongoing investigation into cases following drug’s FDA approval; releases new extension study data.
ASRS reports safety concerns over Apellis' Syfovre
Products

ASRS reports safety concerns over Apellis' Syfovre

A reported six cases of retinal vasculitis have occurred in patients following the first intravitreal injection, the organization says. 
Apellis publishes phase 3 post-hoc analyses on Syfovre for GA
Research

Apellis publishes phase 3 post-hoc analyses on Syfovre for GA

Analysis on 24-month data found visual function and quality-of-life benefits for patients.
FDA approves Syfovre for GA treatment
Products

FDA approves Syfovre for GA treatment

Apellis’s pegcetacoplan injection is now the first and only approved option for patients with GA secondary to AMD.
FDA accepts NDA amendment of PDUFA date for pegcetacoplan for GA
Pipeline

FDA accepts NDA amendment of PDUFA date for pegcetacoplan for GA

Apellis Pharmaceuticals’s new drug application for Syfovre has a new PDUFA target date.