- Organizations: Apellis Pharmaceuticals
Business
Apellis names retinal specialist as chief medical retina advisor
Former ASRS President Philip Ferrone, MD, will assume the role on March 18.
Research
Three-year data supports extended treatment of Syfovre for GA
Phase 3 GALE study results indicate a continued reduction in GA lesion growth.
Products
Positive 24-month data released for phase 3 trials on Syfovre
Latest data supports the FDA-approved therapeutic for treating GA.Products
CMS assigns Syfovre a permanent J-code
Formulation is the first and only treatment FDA-approved for geographic atrophy secondary to AMD.
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.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.
Products
Extension study reinforces Syfovre long-term efficacy for GA
Thirty-month data supports the FDA-approved drug’s use for GA patients.
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.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.
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.
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.
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.
Pipeline
Apellis to submit phase 3 data to FDA for pegcetacoplan NDA
Data is based on the DERBY and OAKS studies for treatment of GA secondary to AMD.
Archives
Lots of AMD news — Weekly Glance
Apellis just released data from the phase 3 Derby and OAKS trials.Archives