一次情報の記録
決定級FDA 承認
Regeneron Pasatru (garetosmab) が FOP に対して FDA 承認
FDA は、線維異形成性骨化進行症 (FOP) の成人患者における新たな異所性骨化病変の形成と医師評価によるフレアアップを低減するために Pasatru (garetosmab) を承認しました。欧州連合でも規制当局への申請が審査中です。
主要事実
出典の抜粋
EX-99.1 2 exhibit991q32026.htm EX-99.1 文書 Exhibit 99.1 プレスリリース Regeneron Reports Third Quarter 2026 Financial and Operating Results • Third quarter 2026 revenues increased 36% to $5.1 billion versus third quarter 2025 • Dupixent ® global net sales (recorded by Sanofi) increased 35% to $6.5 billion • EYLEA HD ® U.S. net sales increased 62% to $699 million • Libtayo ® global net sales increased 51% to $550 million • GAAP EPS increased 35% to $18.45; non-GAAP EPS (a) increased 70% to $20.07 • Expanded collaboration with Sanofi, adding multiple next-generation, long-acting immunology antibodies; $1.0 billion up-front to be recognized as collaboration revenue in fourth quarter 2026 with potential to receive up to an additional $7.0 billion in future milestones • Pasatru ™ (garet