Apellis Pharmaceuticals (NASDAQ:APLS) shares surged more than 30% in premarket Wednesday following the company’s update on its injection kits and rare events of retinal vasculitis reported in real-world treatment with SYFOVRE (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Regarding the injection kits, the company discovered structural variations in the 19-gauge x 1½ inch filter needles in specific kits. Although there's no confirmed link between these differences and the rare events of retinal vasculitis in the real world, Apellis advised practitioners to switch to 18-gauge filter needles, which are already in distribution.
“To date, more than 100,000 vials have been distributed for commercial use and for administration in clinical trials, and the events of retinal vasculitis continue to be very rare at an estimated real-world rate of 0.01% per injection. We believe SYFOVRE is an important medicine for patients living with this chronic disease and are committed to providing patients with a meaningful and safe treatment,” said Caroline Baumal, M.D., chief medical officer of Apellis.
Wells Fargo analysts took note of this positive update.
"While there is no causal relationship between the 19g needle and RV, the reported rate of RV (or suspected RV) relative to vials since the last update remains low," the analysts said.
Bank of America analysts added:
"We view the update positively as it indicates these cases are still rare and demand for Syfovre continues following these observations. We will continue to monitor for updates on ORV rates and demand near-term that could provide upside to our estimates."
(Additional reporting by Senad Karaahmetovic)