- Trial Phase
- Filed/NDA (CRL received)
- Time to Market
- Unknown — dependent on CMC resubmission timing and FDA review cycle. The company has not provided a specific resubmission date. Cash runway extends into mid-2027.
- Why 4/10
- CTx-1301 is Cingulate's only pipeline asset and essentially the entire company value, but the defining binary catalyst (the May 31, 2026 PDUFA) has already passed with a CRL outcome. The next catalyst — NDA resubmission — has no specific date, so there is no hard dated binary in the next ~12 months. The stock is range-bound around $5, reflecting the regulatory overhang and uncertain timeline.
Watch for the NDA resubmission announcement — that is the next major catalyst. Without a specific resubmission date, the stock is likely range-bound around current levels. The CRL was purely CMC-related (no efficacy/safety issues), which limits downside but also means the approval timeline is uncertain. The elevated short-volume ratio (~45%) and single-asset binary nature make this a high-risk, high-reward name for event-driven investors.
Price Chart
Executive Summary
CTx-1301 is Cingulate Inc.'s lead and only pipeline asset — a proprietary extended-release formulation of dexmethylphenidate (the active ingredient in Focalin XR) for ADHD, delivered via the company's Precision Timed Release (PTR) technology. A Phase 3 trial in adults completed successfully, and the NDA was accepted for FDA review with a May 31, 2026 PDUFA date. However, on June 1, 2026, the FDA issued a Complete Response Letter (CRL) citing only Chemistry, Manufacturing, and Controls (CMC) deficiencies — no clinical safety or efficacy issues were raised. Cingulate is working on CMC remediation and NDA resubmission, but has not provided a specific timeline. The stock trades at ~$5.02, far below the mean analyst price target of $21.20, reflecting the regulatory overhang. The company has ~$28.4M in cash (runway into mid-2027) and recently secured a U.S. patent through 2042 and a distribution agreement with Prasco.
How It Works
CTx-1301 is an extended-release formulation of dexmethylphenidate, a central nervous system stimulant that is the active ingredient in Focalin XR. It works by increasing levels of dopamine and norepinephrine in the brain, which helps improve focus and reduce impulsivity/hyperactivity in ADHD patients. Cingulate's proprietary Precision Timed Release (PTR) technology is designed to deliver the drug in a specific release profile that may offer improved tolerability or dosing convenience compared to existing products.
Trial Status
A Phase 3 efficacy and safety study in adults with ADHD (NCT05631626) was completed in June 2023 with 26 enrolled participants. The NDA was accepted for FDA review in October 2025 under the 505(b)(2) pathway. On June 1, 2026, the FDA issued a Complete Response Letter citing only Chemistry, Manufacturing, and Controls (CMC) deficiencies — no clinical safety or efficacy concerns were raised. The company is actively working on CMC remediation for resubmission but has not provided a specific timeline.
The Two-Sided Case
Upcoming Catalysts
- NDA resubmission announcement (no date set)
- FDA acceptance of resubmission for review
- Potential new PDUFA date following resubmission
Source Filing
The SEC filing that triggered this drug report: