Cingulate Inc. Submits New Drug Application for Lead Asset CTx-1301, Anticipates FDA Decision in Q4 2025

Cingulate Inc. reported Q2 2025 financial results and provided recent highlights, including the submission of a New Drug Application to the FDA for lead asset CTx-1301. The company anticipates an FDA decision in Q4 2025 regarding NDA acceptance with a potential PDUFA date in mid-2026. Cash and working capital were approximately $8.9 million and $3.5 million, respectively, as of June 30, 2025. The company expects its cash to last into late 2025 under the current business plan.