Cingulate gets FDA Complete Response Letter for CTx-1301
Cingulate said the FDA issued a Complete Response Letter for its CTx-1301 NDA on June 1, 2026, and the company is addressing CMC issues with plans to resubmit promptly. Management will present the commercialization and launch strategy for CTx-1301 at an upcoming event.
Cingulate, Inc. (NASDAQ:CING) said the FDA issued a Complete Response Letter for the CTx-1301 NDA on June 1, 2026. The company said it is addressing CMC issues and plans to resubmit promptly. CEO Shane Schaffer and CCO Bryan Downey will outline commercialization and CTx-1301 launch strategy at the Ind…