BioCentury
ARTICLE | Product Development

July 31 Quick Takes: Apellis dips on news of safety signal for Syfovre

Plus: Elahere sales fail to buoy ImmunoGen’s shares and updates from Sumitomo-Otsuka, Citius and Quest

July 31, 2023 11:08 PM UTC

Shares of Apellis Pharmaceuticals Inc. (NASDAQ:APLS) were off $6.27 (20%) to $25.75 Monday after the company acknowledged seven cases of retinal vasculitis that emerged after injections of Syfovre pegcetacoplan in real-world settings. The biotech said there had been no cases of retinal vasculitis in clinical trials of Syfovre, which FDA approved in February to treat geographic atrophy associated with age-related macular degeneration, and no indication that its drug product or manufacturing were linked to the retinal vasculitis cases. Apellis said Monday that sales of Syfovre were $67.3 million during 2Q23, its first full quarter on the market.

The announcement by ImmunoGen Inc. (NASDAQ:IMGN) that CMO Anna Berkenblit would be leaving overshadowed the growth in sales of Elahere mirvetuximab soravtansine-gynx reported Monday, sending the company’s shares down $1.70 to $17.82. Elahere’s net sales more than doubled to $77.4 million in 2Q23 from $29.9 million in 1Q23. ImmunGen said its plans for Elahere include 4Q23 submissions of an MAA in Europe and an sBLA in the U.S.; the latter would convert the ADC’s accelerated approval to full approval based on Phase III data that read out in May. ...