Apellis Pharmaceuticals Inc

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Products, Regulatory

Apellis Reiterates Plans To Submit A New Drug Application In The First Half Of 2022

Published: 11/12/2021 12:41 GMT
Apellis Pharmaceuticals Inc (APLS) - Apellis Reiterates Plans to Submit a New Drug Application in the First Half of 2022 for Pegcetacoplan for Geographic Atrophy Following FDA Feedback.
Apellis Pharmaceuticals - Received Formal, Written Feedback From U.S. FDA.
Apellis Pharmaceuticals - Feedback From FDA Further Reinforces Plans to Submit NDA for Pegcetacoplan Ga Secondary to Age-related Macular Degeneration.
Apellis Pharmaceuticals Inc - NDA Will Be Supported by Efficacy and Safety Data From Phase 3 Derby and Oaks Studies and Phase 2 Filly Study.
Apellis Pharma - Based on FDA's Feedback, Remains on Track to Submit NDA in H1 2022, Believes No Additional Studies Will Be Needed for Submission.