Cingulate: CTx-1301 NDA PDUFA itinakda sa Mayo 31, 2026

Tinanggap ng FDA ang CTx-1301 NDA at nagtalaga ng PDUFA target action date na Mayo 31, 2026. Kasalukuyang tumutugon ang Cingulate sa mga kahilingan ng impormasyon mula sa FDA tungkol sa manufacturing at CMC elements habang isinusulong ang mga paghahanda para sa commercial launch.

Mahahalagang fact

Na-file: May 14, 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 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