NVS - Why Is Neurology Focused Cingulate Stock Trading Higher Today? | Benzinga
On Tuesday, Cingulate Inc (NASDAQ: 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 (NYSE: 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 ...