Cingulate Inc. Reports Second Quarter 2025 Financial Results and Provides Recent Highlights

About this update from Cingulate Inc.

[{"type":"image","alt":"Cingulate Inc.","displaySize":"","headline":null,"caption":"Cingulate Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":300,"url":"https://media.zenfs.com/en/globenewswire.com/e62a6f953f929d09857897121e95d193"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/lmh6sY4ewRXV2DZQkTXk7Q--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTQyMDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/e62a6f953f929d09857897121e95d193","width":300,"height":300}},"lazy":false},{"type":"text","content":"Submitted New Drug Application (NDA) to the FDA for lead asset CTx-1301Anticipate FDA Decision in Q4 2025 regarding NDA Acceptance with Potential PDUFA Date in Mid-2026","length":169,"tagName":"p"},{"type":"text","content":"KANSAS CITY, Kan., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced its financial results for the quarter ended June 30, 2025, and provided recent highlights.","length":386,"tagName":"p"},{"type":"text","content":"Recent Highlights:","length":18,"tagName":"p"},{"type":"text","content":"On July 31, 2025, Cingulate submitted its NDA to the FDA for CTx-1301, a novel, extended-release tablet formulation of dexmethylphenidate designed to deliver a fast onset, entire active-day efficacy, and a smooth pharmacokinetic profile with a single dose, addressing major limitations of current ADHD therapies. The FDA guides that a decision is often made regarding acceptance of the NDA within 60 days. Submission of the NDA came after the following second quarter activities:","length":499,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Pre-NDA meeting with the FDA;","length":29,"tagName":"p"}]},{"val":[{"type":"text","content":"Announcement of positive top-line results from the high dose (50mg) fed/fast study of CTx-1301, demonstrating that CTx-1301 can be taken with or without food; and","length":162,"tagName":"p"}]},{"val":[{"type":"text","content":"Announcement of results of Phase 3 pediatric study of CTx-1301, demonstrating marked improvement of ADHD symptoms at week five, illustrating the potential benefits of the product and the value of the Pr...

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