Cingulate Secures $12M PIPE, NDA Accepted with May 31 PDUFA Date
Cingulate’s NDA for CTx-1301 was accepted under the FDA’s 505(b)(2) pathway with a PDUFA target action date of May 31, 2026, based on Phase 3 trials showing rapid-onset and sustained ADHD control. The company secured $12 million in PIPE financing, bolstered its patent estate with a U.S. Notice of Allowance and a European patent extending protection to May 2042.
1. NDA Acceptance and PDUFA Date
Cingulate’s New Drug Application for CTx-1301 was accepted by the FDA under the 505(b)(2) pathway with a PDUFA target action date of May 31, 2026. The NDA is supported by Phase 3 clinical trials demonstrating rapid-onset and sustained ADHD symptom control across adult and pediatric patients.
2. Patent Portfolio Strengthening
On March 17, 2026, the USPTO issued a Notice of Allowance for a patent covering key formulation and method-of-use claims for CTx-1301, expected to extend protection through May 2042. A European patent (EP No. 22808184) granted on December 17, 2025 covers CTx-1301’s tri-modal precision release profile and will be validated in over 30 territories.
3. Financing and Capital Position
In February 2026, Cingulate closed a $12 million at-the-market PIPE financing led by affiliates of Falcon Creek Capital, featuring a 180-day lock-up and rights to designate up to two board members. As of December 31, 2025, the company held $11.0 million in cash and equivalents, projected to fund operations into late Q4 2026.
4. Commercial and Manufacturing Progress
The company advanced commercial readiness by appointing Bryan Downey as Chief Commercial Officer and initiating manufacturing scale-up and distribution planning. Cingulate continues market access and payer engagement activities to support a potential CTx-1301 launch upon regulatory approval.