Cingulate：FDA接受CTx-1301 NDA；PDUFA定于2026年5月31日

FDA已接受CTx-1301（盐酸右哌甲酯）ADHD适应症的NDA，并指定PDUFA目标行动日期为2026年5月31日。该受理确认申请材料完整，可进行实质性审查。同时还签署了与Bend Bio Sciences的商业供应协议，若获批，将负责美国至2028年的生产。

关键事实

申报时间: 2025年11月13日 13:15
事件: 申请已受理
方向: 积极
公司: CINGCingulate
资产: dexmethylphenidate HCl
来源: SEC 8-K
可信度: 有来源
日历: FDA 审批决定 (PDUFA) · 2026年5月31日 · 完整回复函 (CRL)
PDUFA费用减免: 430万美元

来源摘录

EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Cingulate Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update Industry Veteran Bryan Downey Named Chief Commercial Officer NDA Accepted with May 2026 PDUFA Date Commercial Supply Agreement Executed KANSAS CITY, Kan., Nov. 13, 2025 — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to build a pipeline of next-generation products, today announced financial results for the quarter ended September 30, 2025, and provided recent corporate highlights. Recent Highlights (Post-Q3) FDA Accepts NDA for CTx-1301; PDUFA Date Set for May 31, 2026 In October of 2025, the U.S. Food and Drug Administration (FDA) accepted Cingulate’s New D

SEC 8-K