Cingulate : date d'action cible PDUFA de la NDA CTx-1301 fixée au 31 mai 2026

La FDA a accepté la NDA CTx-1301 et a attribué une date d'action cible PDUFA au 31 mai 2026. Cingulate répond actuellement aux demandes d'informations de la FDA concernant les éléments de fabrication et de CMC tout en faisant progresser les préparatifs du lancement commercial.

Faits clés

Déposé: 14 mai 2026, 12:10
Événement: Date PDUFA fixée
Direction: Neutre
Société: CINGCingulate
Actif: dexmethylphenidate HCl
Source: SEC 8-K
Fiabilité: Sourcé
Calendrier: Décision FDA (PDUFA) · 31 mai 2026 · Lettre de réponse complète

Extrait de la 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