Cingulate: FDA menerima NDA CTx-1301; PDUFA ditetapkan 31 Mei 2026

FDA menerima NDA untuk CTx-1301 (dexmethylphenidate HCl) untuk ADHD dan menetapkan tanggal aksi target PDUFA pada 31 Mei 2026. Penerimaan ini mengonfirmasi bahwa aplikasi telah lengkap untuk tinjauan substantif. Perjanjian pasokan komersial dengan Bend Bio Sciences juga telah dieksekusi untuk manufaktur di AS hingga 2028 jika disetujui.

Fakta utama

Diajukan: 13 Nov 2025, 13.15
Peristiwa: Permohonan diterima
Arah: Positif
Perusahaan: CINGCingulate
Aset: dexmethylphenidate HCl
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 31 Mei 2026 · Surat tanggapan lengkap
pembebasan biaya PDUFA: $4.3 juta

Kutipan sumber

EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Cingulate Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update Industry Veteran Bryan Downey Named Chief Commercial Officer NDA Accepted with May 2026 PDUFA Date Commercial Supply Agreement Executed KANSAS CITY, Kan., Nov. 13, 2025 — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to build a pipeline of next-generation products, today announced financial results for the quarter ended September 30, 2025, and provided recent corporate highlights. Recent Highlights (Post-Q3) FDA Accepts NDA for CTx-1301; PDUFA Date Set for May 31, 2026 In October of 2025, the U.S. Food and Drug Administration (FDA) accepted Cingulate’s New D

SEC 8-K