Cingulate：FDA为CTx-1301 ADHD NDA设定2026年5月31日PDUFA日期

FDA已受理CTx-1301（盐酸右哌甲酯）的NDA申请，采用505(b)(2)途径，并指定PDUFA目标行动日期为2026年5月31日。该申请由3期数据显示支持，显示在6岁及以上患者中具有快速起效和全天持续疗效。FDA要求提供额外的CMC/生产信息，但未提出临床安全性或疗效问题。

关键事实

申报时间: 2026年3月18日 12:10
事件: PDUFA 日期确定
方向: 中性
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)

来源摘录

EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Cingulate Inc. Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights U.S. Patent Notice of Allowance for CTx-1301 Received; Additional European Patents Granted Recent $12M Private Placement Closed At-the-Market Pricing KANSAS CITY, Kan., March 18, 2026 -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today reported financial results for the quarter ended December 31, 2025, and provided a corporate update. Highlights include recent U.S. and European patent developments, the closing of a $12 million private investment, and the acceptance of a New Drug Application (NDA) f

SEC 8-K