Cingulate: FDA, CTx-1301 ADHD NDA의 PDUFA 날짜를 2026년 5월 31일로 지정

FDA accepted the NDA for CTx-1301 and assigned a PDUFA target action date of May 31, 2026. The company named Bryan Downey Chief Commercial Officer to prepare for potential launch and completed a $6 million financing to extend cash runway into Q2 2026.

핵심 사실

제출: 2025년 11월 10일 PM 01:17
이벤트: PDUFA 날짜 확정
방향: 중립
기업: CINGCingulate
자산: dexmethylphenidate HCl
출처: SEC 8-K
신뢰도: 출처 확인
캘린더: FDA 심사 결정 (PDUFA) · 2026년 5월 31일 · 보완요구서한 (CRL)

출처 발췌

EX-99.1 5 ex99-1.htm EX-99.1 Exhibit 99.1 Cingulate Names Industry Veteran Bryan Downey Chief Commercial Officer to Lead Launch Preparation for CTx-1301 Appointment builds on recent FDA acceptance of New Drug Application for review and advances Cingulate’s transition toward commercialization pending FDA approval Company also strengthens its cash position by completing a $6 million financing KANSAS CITY, Kan., Nov.10, 2025 — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release™ (PTR™) drug-delivery platform, today announced the appointment of Bryan Downey as Chief Commercial Officer, following the U.S. Food and Drug Administration’s (FDA) acceptance of

SEC 8-K