Following the oral explanation meeting on December 13, Apellis was informed of a negative trend vote on the MAA for pegcetacoplan. 

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.

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

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