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Cingulate Inc. (NASDAQ:CING) a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release™ (PTR™) drug-delivery platform, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for CTx-1301 (dexmethylphenidate), the company's lead candidate for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adults. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. NDA acceptance signifies that the Agency has determined the submission is sufficiently complete to permit substantive review.
A Key Regulatory Milestone Under the 505(b)(2) Pathway
This marks a major regulatory inflection point for Cingulate and for the CTx-1301 program. CTx-1301 is being reviewed under the FDA's 505(b)(2) regulatory pathway, which allows sponsors to reference existing data on previously approved active ingredients while demonstrating novel clinical benefit through a differentiated delivery mechanism. For Cingulate, this pathway offers the opportunity to leverage the extensive safety and efficacy data of dexmethylphenidate—an established and well-characterized stimulant—while enabling CTx-1301 to demonstrate rapid onset of effect and entire active-day duration through its proprietary multi-core PTR™ technology.
The NDA submission follows completion of adult and pediatric Phase 3 trials, completion of all FDA-requested studies, and a positive pre-NDA meeting in April 2025 confirming adequacy of the clinical and Chemistry, Manufacturing, and Controls (CMC) data packages for review. The FDA's acceptance validates that Cingulate's application meets the Agency's standards for completeness and marks the beginning of the formal review period.
Posted In: CING
