Apellis Announces Pegcetacoplan MAA Review Has Been Reset to Day 180 of Initial Assessment by European Medicines Agency (EMA)

April 26, 2024

https://www.globenewswire.com/news-release/2024/04/26/2870392/0/en/Apellis-Announces-Pegcetacoplan-MAA-Review-Has-Been-Reset-to-Day-180-of-Initial-Assessment-by-European-Medicines-Agency-EMA.html

WALTHAM, Mass., April 26, 2024 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (Nasdaq:APLS) today announced that the European Medicines Agency (EMA) has reset the review of the marketing authorization application (MAA) for intravitreal pegcetacoplan for geographic atrophy to the last phase of the initial assessment (day 180). The procedure is expected to be led by the original rapporteurs, and EMA has stated their intent to convene a new expert group meeting. Apellis anticipates an opinion from the Committee for Medicinal Products for Human Use (CHMP) no later than July 2024.

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