Cingulate：CTx-1301 NDA PDUFA 日期定于 2026 年 5 月 31 日

FDA 已受理 CTx-1301 NDA 并指定 PDUFA 目标行动日期为 2026 年 5 月 31 日。Cingulate 目前正在回复 FDA 关于生产和 CMC 要素的信息请求，同时推进商业化上市准备工作。

关键事实

申报时间: 2026年5月14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 First Quarter 2026 Financial Results and Provides an Update of Commercial Readiness Efforts On Track for lead ADHD Asset CTx-1301 Cash Position Grows to $25.9 Million KANSAS CITY, Kan., May 14, 2026 (GLOBE NEWSWIRE) -- 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 March 31, 2026, and provided a corporate update. “Cingulate remains focused on disciplined execution in 2026 and we believe we are well positioned to bring our lead ADHD asset, CTx-1301, to market,” said Cingulate CEO Shane J. Schaffer. “We continue to engage const

SEC 8-K