Cingulate reports Phase 3 safety data for ADHD drug CTx-1301; no serious adverse events in final trials

Cingulate Inc.

No serious treatment-emergent adverse events, deaths, or clinically relevant trends in two pediatric Phase 3 studies and one food-effect study.
Food-effect study with 50mg dose shows CTx-1301 can be taken with or without food, consistent with prior 25mg study.
Final combined adult and pediatric safety and efficacy analysis expected mid-2025 for NDA submission.
Pre-NDA in-person meeting with FDA scheduled for April 2, 2025.
Company had 3,647,655 shares of common stock outstanding as of March 4, 2025.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.