Latest News and Press Releases

Want to stay updated on the latest news?

Sign into Reader Account Create Reader Account

October 28, 2025 08:00 ET | Source: Cingulate Inc.

Cingulate Presents Positive Phase 3 Results for CTx-1301 Demonstrating Statistically Significant Efficacy and Entire Active-Day Symptom Control

KANSAS CITY, Kan., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products...
October 23, 2025 16:45 ET | Source: Cingulate Inc.

Cingulate’s Lead ADHD Candidate CTx-1301 Selected for Podium Presentation at AACAP Annual Meeting

KANSAS CITY, Kan., Oct. 23, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products...
October 14, 2025 08:00 ET | Source: Cingulate Inc.

FDA Accepts Cingulate’s New Drug Application for CTx-1301 in Attention-Deficit/Hyperactivity Disorder (ADHD) and sets a May 31, 2026 PDUFA Date

Once-daily Precision Timed Release™ (PTR™) stimulant designed to deliver rapid onset of effect and entire active-day duration NDA accepted under the FDA’s 505(b)(2) regulatory pathway KANSAS...
September 17, 2025 08:45 ET | Source: Cingulate Inc.

Cingulate Secures Exclusive Manufacturing Partnership with Bend Bio Sciences to Support Future Commercialization of Next Generation ADHD Treatment

KANSAS CITY, Kan., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform...
August 15, 2025 09:00 ET | Source: Cingulate Inc.

Cingulate Provides Management Team Update

Jennifer Callahan, Chief Financial Officer, appointed Interim CEO Board member, Jay Roberts appointed Executive Chairman KANSAS CITY, Kan., Aug. 15, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CING)...
August 06, 2025 08:45 ET | Source: Cingulate Inc.

Cingulate Submits New Drug Application to FDA for Lead ADHD Asset CTx-1301

KANSAS CITY, Kan., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform...
July 29, 2025 08:00 ET | Source: Cingulate Inc.

Cingulate Receives $4.3M Waiver from FDA Ahead of Imminent Filing for Marketing Approval of Lead ADHD Asset CTx-1301

KANSAS CITY, Kan., July 29, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform...
July 09, 2025 08:00 ET | Source: Cingulate Inc.

Cingulate Appoints Nilay Patel as Chief Legal Officer to Support Growth ahead of New Drug Application

KANSAS CITY, Kan., July 09, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform...
May 20, 2025 08:00 ET | Source: Cingulate Inc.

Efficacy Results Announced from Cingulate’s Phase 3 Pediatric Study of CTx-1301 (dexmethylphenidate) for ADHD

Subjects Demonstrated Marked Improvement of ADHD Symptoms at Week 5New Drug Application on Schedule for this Summer CING CEO Shares Insights and Strategic Outlook on “Unboxing Biotech” Podcast ...
May 14, 2025 08:00 ET | Source: Cingulate Inc.

FDA and Cingulate Aligned with Filing Requirements for New Drug Application for Lead ADHD Asset CTx-1301

Pre-NDA Minutes from April 2, 2025, Meeting Received NDA Submission Planned this Summer KANSAS CITY, Kan., May 14, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical...