$CING (Cingulate) — 8-K: Cingulate CEO updates on CTx-1301 NDA resubmission after June 1, 2026 FDA Complete Response Letter

Cingulate said CEO Shane Schaffer provided an update on regulatory progress for CTx-1301, its lead ADHD asset, in an interview airing November 10, 2026. The FDA accepted the CTx-1301 NDA in October 2025 with a PDUFA target action date of May 31, 2026, then issued a Complete Response Letter on June 1, 2026. Cingulate said it is working to complete the requested CMC work and plans to resubmit the NDA as promptly as practicable, with no assurance on timing or approval.

Cingulate said CEO Shane Schaffer provided an update on regulatory progress for CTx-1301, its lead ADHD asset, in an interview airing November 10, 2026. The FDA accepted the CTx-1301 NDA in October 20