Why Is Apellis Pharmaceuticals Stock Trading Lower Today?

Apellis Pharmaceuticals Inc APLS announced an update on the ongoing review of its marketing application for intravitreal pegcetacoplan for 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).

Earlier in the year, Apellis welcomed the launch of Syfovre, making it the first FDA-approved treatment for this debilitating eye condition without the advisory committee's usual vetting process. However, Citron Research noted in a report that the decision has been controversial since then.

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 for January 22-25, 2024. 

If a negative opinion is adopted, Apellis plans to appeal the outcome and seek re-examination of the opinion.

The MAA is based on results from the Phase 3 OAKS and DERBY studies at 24 months, published in The Lancet. Treatment with every-other-month and monthly pegcetacoplan reduced GA lesion growth with increasing treatment effects over time and showed a well-demonstrated safety profile. 

Additionally, pegcetacoplan preserved visual function longer in multiple post hoc Phase 3 analyses presented at medical congresses.

In July, Apellis Pharmaceuticals disclosed safety events connected to Syfovre. 

Price Action: APLS shares are down 17.3% at $52 on the last check Thursday.

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