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

FDA 已受理 CTx-1301 NDA 並指定 PDUFA 目標行動日期為 2026 年 5 月 31 日。Cingulate 目前正回應 FDA 關於製造及 CMC 要素的資訊要求，同時推進商業上市準備工作。

關鍵事實

申報時間: 2026年5月14日下午12:10
事件: PDUFA 日期確定
方向: 中性
公司: CINGCingulate
資產: dexmethylphenidate HCl
來源: SEC 8-K
可信度: 有出處
行事曆: FDA 審查決定 (PDUFA) · 2026年5月31日 · 完整回覆函 (CRL)

來源摘錄

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