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DewDiligence

07/19/22 11:05 AM

#243230 RE: DewDiligence #242666

APLS—(+25%)—gets 11/26/22 PDUFA date for dry-AMD NDA—(with FDA priority review):

https://www.globenewswire.com/news-release/2022/07/19/2481617/0/en/Apellis-Announces-FDA-Acceptance-and-Priority-Review-of-the-New-Drug-Application-for-Pegcetacoplan-for-the-Treatment-of-Geographic-Atrophy-GA.html

No FDA advisory panel is expected, according to the PR. This is surprising in that APLS’ pivotal trial missed its primary endpoint (#msg-165847030).