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. (CINGW) generates news primarily as a clinical-stage biopharmaceutical company advancing its Precision Timed Release™ (PTR™) drug delivery platform and lead ADHD asset, CTx-1301. News coverage for Cingulate often centers on regulatory milestones, clinical data disclosures, financing activities, and steps toward commercialization of its once-daily stimulant formulation.
Investors following CINGW news will see updates on CTx-1301’s regulatory path, including the submission and FDA acceptance of the New Drug Application (NDA) under the 505(b)(2) pathway and the assignment of a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. Press releases also highlight Phase 3 clinical results in adult and pediatric ADHD populations, with reported dose-dependent improvements on standard ADHD rating scales and sustained efficacy into evening hours, as well as safety findings consistent with other long-acting methylphenidate products.
Cingulate’s news flow also covers corporate and commercial developments, such as the appointment of senior executives to support launch preparation, exclusive manufacturing and supply agreements with Bend Bio Sciences for CTx-1301, and a commercialization partnership with Indegene built around an AI-driven, digital-first platform. Financing announcements, including a committed equity facility with Lincoln Park Capital and debt-related transactions, appear in both press releases and related SEC filings and can influence the company’s capital position ahead of potential commercialization.
In addition, Cingulate issues regular quarterly financial updates that summarize research and development spending, general and administrative expenses, net loss, and cash runway expectations, often alongside clinical and regulatory highlights. For those tracking developments in ADHD therapeutics and PTR™-based drug delivery, the CINGW news stream provides a consolidated view of Cingulate’s progress from late-stage development toward a possible commercial phase, subject to FDA review outcomes.
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