FDA issues anticipated revised label for Apellis’ Syfovre, says Wedbush

Wedbush keeps a Neutral rating on Apellis shares after the FDA issued a revised label Syfovre in geographic atrophy following its analysis/review of recent retinal vasculitis events. The FDA’s move was largely anticipated given the focus on the retinal vasculitis events and the label incorporates new language in the warnings/precautions section, the analyst tells investors in a research note. The key to unlocking additional Apellis value remains tied to re-accelerating Syfovre commercial uptake and securing ex-U.S. Syfovre approvals, Wedbush contends.