On Tuesday, Cingulate Inc CING received FDA guidance for CTx-1301 (dexmethylphenidate), its lead investigational product candidate for attention deficit hyperactivity disorder (ADHD).
The company expects to submit the NDA for CTx-1301 in 1H of 2025 under the Section 505(b)(2) pathway with Novartis AG's NVS Focalin XR as the reference listed drug.
Cingulate stopped enrollment in the pivotal Phase 3 fixed-dose pediatric and adolescent safety and efficacy study that commenced in late July 2023 and the Phase 3 pediatric dose-optimization onset and duration study that commenced in early August 2023.
Furthermore, Cingulate will update the CTx-1301 initial Pediatric Study Plan.
The company needs approximately $17 million-$21 million of capital to achieve the NDA filing for CTx-1301. This capital requirement is approximately $9-13 million less than initially anticipated.
The company plans to initiate its clinical plan for CTx-1302 (dextroamphetamine), its second investigational asset for ADHD, as soon as 2025, pending additional capital resources.
Cingulate is in active license conversations, and pending a definitive agreement, the development of CTx-2103 (buspirone) for anxiety may begin as soon as 2025, pending additional capital resources.
The company received a letter from the Listing Qualifications Staff of Nasdaq indicating that, based upon the resignation of three board members, the company no longer complies with Nasdaq's independent director, audit committee, compensation committees, and independent director oversight of director nomination requirements.
The Staff indicated that this non-compliance is an additional and separate basis for delisting securities from Nasdaq.
At the Panel hearing, expected to occur in February 2024, the company will submit a plan to regain compliance and sustain long-term compliance with all applicable requirements for continued listing on the Nasdaq.
Price Action: CING shares are up 174.2% at $10.94 on the last check Thursday.
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