Biotech Values

[DewDiligence]

APLS -20% on negative CHMP opinion for Syfovre:

https://www.globenewswire.com/news-release/2023/12/14/2796136/0/en/Apellis-Provides-Update-on-Ongoing-Regulatory-Review-of-Pegcetacoplan-for-GA-in-the-European-Union.html

Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced today an update on the ongoing review of its marketing authorization application (MAA) for intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Following the oral explanation meeting on December 13, Apellis was informed of a negative trend vote on the MAA for pegcetacoplan. Apellis expects the CHMP to adopt a negative opinion at its next meeting, which is scheduled to be held January 22-25, 2024.

I’ve been bearish on APLS’ Syfovre—see, for instance, #msg-171260849.