Welcome to our dedicated page for Cingulate news (Ticker: CING), 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 Timed Release™ (PTR™) technology to develop advanced treatments for ADHD and anxiety disorders. This page serves as the definitive source for verified company updates, offering investors and healthcare professionals timely access to essential developments.
Find comprehensive coverage of clinical trial milestones, regulatory submissions, and strategic partnerships shaping Cingulate's innovative pipeline. Our curated news collection includes updates on lead candidate CTx-1301's FDA review process, intellectual property expansions, and manufacturing advancements for PTR™-enabled therapies.
Key updates feature progress in addressing ADHD treatment limitations through single-dose efficacy solutions and developments in anxiety disorder management via novel drug delivery systems. All content undergoes rigorous verification to ensure alignment with financial reporting standards and medical accuracy.
Bookmark this page for streamlined access to Cingulate's latest biopharmaceutical innovations, patent filings, and market expansion initiatives. Stay informed about critical developments in precision drug delivery technology without promotional bias or speculative content.
Cingulate announced the exercise of outstanding Series A and B warrants at a reduced price of $0.585 per share, generating gross proceeds of approximately $1.86 million. Originally issued in February 2023 with an exercise price of $2.00, the warrants allow the purchase of up to 3,187,500 shares of common stock. The transaction, facilitated by H.C. Wainwright & Co., is expected to close by July 1, 2024. In return, Cingulate will issue new Series C and D warrants to purchase up to 6,375,000 shares at the same reduced price, exercisable upon shareholder approval. Proceeds will fund R&D, commercialization of CTx-1301, and general corporate needs.
Cingulate, a biopharmaceutical company listed on NASDAQ under the symbol CING, will host a live event featuring CEO Shane J. Schaffer and ADHD expert Dr. Ann Childress. The event will be held on June 26, 2024, at 10:30 a.m. CST, and will be accessible via Benzinga’s YouTube channel and Cingulate’s website. During the event, the discussion will cover unmet needs in ADHD, results from Cingulate’s Phase 3 Fixed-Dose Study in pediatrics and adolescents, and potential expansion of the company's Precision Timed Release™ platform into other therapeutic areas. Dr. Schaffer will also provide a company overview.
Cingulate announced a significant achievement in the development of its ADHD drug, CTx-1301, by completing twelve required registration batches. This milestone meets the U.S. Food and Drug Administration (FDA) manufacturing requirements necessary for New Drug Application (NDA) submission. The company is using its Precision Timed Release™ (PTR™) technology to develop CTx-1301, intended to offer a reliable manufacturing process and acceptable shelf life. Cingulate plans to submit the NDA for CTx-1301 in the first half of 2025, marking a important step towards FDA marketing clearance.
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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