regulatory
confidence high
sentiment negative
materiality 0.85
Apellis receives negative trend vote on EU MAA for pegcetacoplan; expects CHMP negative opinion in Jan 2024
Apellis Pharmaceuticals, Inc.
- CHMP negative trend vote on MAA for intravitreal pegcetacoplan for geographic atrophy (GA) after Dec 13 oral explanation.
- Apellis expects CHMP to adopt negative opinion at Jan 22-25, 2024 meeting.
- Company plans to appeal and seek re-examination of the opinion.
- Pegcetacoplan is for GA secondary to age-related macular degeneration.