Shares of Apellis Pharmaceuticals Surge After Safety Concerns Addressed
Shares of Apellis Pharmaceuticals saw a significant boost in post-market trading on Tuesday, following an update on their eye-disease drug Syfovre. This update comes after recent safety concerns surrounding the medication.
Stock Surge
Apellis’ stock surged by 32% to reach $40.78. In contrast, the shares had closed the market session down by 2.3% at $30.76. This year, the stock has experienced a decline of 41%.
Lack of Causal Relationship
Apellis Pharmaceuticals stated that they have not established a causal relationship between structural variations in a 19-gauge filter needle and occurrences of retinal vasculitis.
Recommendations for Practitioners
To address the safety concerns, the company recommends that practitioners immediately discontinue the use of injection kits containing the 19-gauge filter needle. Instead, they should use injection kits with the 18-gauge filter needle, which are already available in distribution. Apellis Pharmaceuticals will exclusively distribute injection kits with the 18-gauge filter needle moving forward.
Rare Occurrences
According to Chief Medical Officer Caroline Baumal, over 100,000 vials of the drug have been distributed for commercial use and clinical trials. The company reports that events of retinal vasculitis remain very rare, estimated at a real-world rate of only 0.01% per injection.
Retinal Vasculitis Cases
A recent notification by the American Society of Retina Specialists highlighted that six patients experienced occlusive retinal vasculitis after receiving their initial Syfovre injections. However, Apellis Pharmaceuticals’ final-phase studies did not report any patients experiencing this severe form of inflammation.
Approved Therapy
Syfovre is an approved therapy for geographic atrophy secondary to age-related macular degeneration.