Welcome to our dedicated page for Cingulate news (Ticker: CINGW), a resource for investors and traders seeking the latest updates and insights on Cingulate stock.
Cingulate Inc. (NASDAQ: CING) is a clinical-stage biopharmaceutical company pioneering precision drug delivery through its Precision Timed Release™ (PTR™) platform. This dedicated news hub provides investors and healthcare professionals with essential updates on clinical developments, regulatory milestones, and strategic partnerships.
Access real-time information about Cingulate's ADHD treatment candidates like CTx-1301, anxiety disorder therapies including CTx-2103, and global patent expansions. Our curated news collection covers FDA submissions, clinical trial results, technology licensing agreements, and financial disclosures - all critical for evaluating the company's market position.
Key updates include progress toward the mid-2025 NDA submission for CTx-1301, international patent grants, and developments in the PTR™ platform's application across therapeutic areas. Bookmark this page to stay informed about Cingulate's innovations in precision medication delivery and its impact on treatment adherence challenges.
Cingulate has received FDA confirmation on the requirements for filing a New Drug Application (NDA) for its Phase 3 candidate, CTx-1301, aimed at treating ADHD in patients aged six and older. The FDA has agreed that data from ongoing Phase 3 studies are sufficient for submission under the 505(b)(2) pathway, eliminating the need for further fixed dose and onset/duration studies. Cingulate will also conduct a brief Phase 1 fed/fast study to include in the NDA. The company aims to submit the NDA in the first half of 2025. Cingulate is also negotiating with potential commercialization partners and payers to maximize market access for CTx-1301, which may benefit over 60% of ADHD patients currently using booster doses. The drug has shown promising results, with patients expressing a desire to continue its use post-trial.
Cingulate Inc. reported its first quarter 2024 financial results, showing positive trends with $10 million increase in stockholders' equity and capital raising efforts totaling $10.7 million. The company is on track to file for Marketing Approval with the FDA for CTx-1301 in the first half of 2025. R&D expenses decreased, and total stockholders' equity saw a $10 million increase from the end of 2023.
Cingulate Inc. announced that Peter J. Werth, a successful pharma entrepreneur and investor, will be featured with Chairman and CEO Shane J. Schaffer on a live Benzinga event. Werth will discuss his background and vision for Cingulate, while Schaffer will provide company updates. The event will take place on May 3, 2024, at 12:10 p.m. EST.
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