原始出處紀錄
重大申請已送件
Agios 計劃於 2026 年第二季提交 sickle cell disease 的 mitapivat sNDA
Agios 確認將在 2026 年第二季完成與 FDA 的 pre-sNDA 會議後，依據 FDA 加速核准途徑提交 mitapivat 用於 sickle cell disease 的 sNDA。此項申請緊接在公司先前 thalassemia 核准之後，是該藥物的下一項監管步驟。
關鍵事實
- 申報時間
- 2026年4月29日 上午10:32
- 事件
- 申請已送件
- 方向
- 中性
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
EX-99.1 2 agio-42926xfyxex991earning.htm EX-99.1 Document Agios Reports First Quarter 2026 Financial Results and Provides Business Update • Mitapivat (PYRUKYND® and AQVESME™) generated worldwide net revenues of $20.7 million in the first quarter of 2026, compared to $8.7 million in the first quarter of 2025 • Strong initial U.S. commercial launch of AQVESME in thalassemia, with 242 prescriptions written as of March 31, 2026 • Company plans to submit mitapivat sNDA for sickle cell disease in the second quarter of 2026 • Pipeline advancing to multiple value-driving inflection points in 2026, including two Phase 2 readouts for next-generation PK activator tebapivat • $1.0 billion in cash, cash equivalents, and marketable securities as of March 31, 2026 CAMBRIDGE, Mass. , Apr. 29, 2026
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決策級
2026年7月30日
上午10:32
AGIOAgios