原始出處紀錄
重大申請已受理
Incyte：FDA接受povorcitinib用於化膿性汗腺炎的NDA
FDA於Q1 2026接受Incyte的povorcitinib用於中重度化膿性汗腺炎的NDA。接受觸發標準審查時鐘，潛在美國批准和上市現指引至Q1 2027。該申請是該公司預期在mid-2026至early 2027之間的四項批准之一。
關鍵事實
- 申報時間
- 2026年4月28日 上午11:03
- 事件
- 申請已受理
- 方向
- 正面
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
EX-99.1 2 incy-q12026xexx991.htm EX-99.1 Document Exhibit 99.1 FOR IMMEDIATE RELEASE Incyte Reports First Quarter 2026 Financial Results and Provides Business Updates Total revenue of $1.27 billion and total net sales of $1.10 billion in the first quarter of 2026, an increase of 21% and 20% respectively, compared to the first quarter of 2025 Jakafi ® (ruxolitinib) net sales of $758 million, an increase of 7% compared to the same period in 2025 Opzelura ® (ruxolitinib) cream net sales of $143 million and Hematology and Oncology portfolio net sales of $204 million, an increase of 20% and 116%, respectively, compared to the first quarter of 2025 Four anticipated approvals and launches from mid-2026 into early 2027 Advanced povorcitinib development program, including the New Drug Applicati