The American Society of Retina Specialists’ Research and Safety in Therapeutics Committee distributed a notification to its members on Saturday indicating that six cases of occlusive retinal vasculitis have been observed since Apellis Pharmaceuticals’ Syfovre launched and all events were observed after the first injection, between 7-13 days post injection, Raymond James tells investors in a research note. No specific product lots were implicated and the communication indicated 60,000 vials of Syfovre have been distributed since FDA approval, adds the analyst. Shares of Apellis are down 37% to $53.02 in premarket trading. The firm spoke with Apellis management who confirmed the details. Occlusive retinal vasculitis will likely “cause investors PTSD given Beovu and likely (and rightfully) be *the* bear case going forward,” writes Raymond James. It says the bear case can only be refuted by continued uptake along with conclusions from continued analysis of cases affirming a possible connection with infectious endophthalmitis. The firm notes the launch “so far is going amazing.” It adds that a retinal vasculitis event rate of one in 10,000 is way less than Beovu and shouldn’t impair Syfovre’s prospects. Raymond James keeps a Strong Buy rating on Apellis Pharmaceuticals.
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