Apellis Pharmaceuticals, Inc.
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Latest From Apellis Pharmaceuticals, Inc.
Keeping Track: Gilead Gets CRL For Bulevirtide, CytoDyn Withdraws Leronlimab; Eye and CNS Drug Submissions
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The company said the user fee goal date for pegcetacoplan in geographic atrophy would move from November to February as it submitted longer-term data.
November should see FDA action on what could be the first standardized fecal microbiota transplant product, rare cancer therapies from Y-mAbs and Spectrum, uniQure/CSL’s hemophilia B gene therapy and Provention Bio’s biologic to delay type 1 diabetes.
NGM said a Merck-partnered C3 inhibiting antibody has failed a Phase II study in geographic atrophy, after the biotech’s wholly owned NASH candidate missed in a Phase IIb study in 2021.