Cingulate: itinakda ng FDA ang PDUFA sa Mayo 31, 2026 para sa CTx-1301 ADHD NDA

Tinanggap ng FDA ang NDA para sa CTx-1301 (dexmethylphenidate HCl) sa ilalim ng 505(b)(2) pathway at nagtalaga ng PDUFA target action date na May 31, 2026. Sinusuportahan ang aplikasyon ng Phase 3 data na nagpapakita ng mabilis na pagsisimula at patuloy na bisa sa buong araw na aktibo sa mga pasyenteng 6 taong gulang at mas matanda. Humiling ang ahensya ng karagdagang impormasyon sa CMC/manufacturing, ngunit walang isyu sa klinikal na kaligtasan o bisa ang naipahayag.

Mahahalagang fact

Na-file: Mar 18, 2026, 12:10 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: CINGCingulate
Asset: dexmethylphenidate HCl
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · May 31, 2026 · Complete response letter

Sipi mula sa source

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