Cingulate reports Q2 2026 results, updates CTx-1301 CMC and NDA resubmission plans

Cingulate Inc. reported financial results for the quarter ended June 30, 2026, alongside an update on its lead ADHD candidate CTx-1301 (dexmethylphenidate HCl). The company said it continues to work on the chemistry, manufacturing and controls data needed to resubmit the NDA, working closely with its manufacturing partner, and intends to resubmit as promptly as practicable.¹

The regulatory work follows action by the FDA in June. The FDA had issued a Complete Response Letter on June 1, 2026, asking for additional CMC information, and the letter did not raise concerns about the clinical safety or efficacy of CTx-1301.¹ Earlier, the FDA had accepted the NDA for review in October 2025 and set a PDUFA target action date of May 31, 2026.¹

On the intellectual property side, the U.S. Patent and Trademark Office granted a patent on June 16, 2026, numbered 12,653,791, covering CTx-1301's "Trimodal, Precision-Timed Pulsatile Release Tablet," with claims protecting the drug's formulation and method of use through December 2042.¹ This marks the first U.S. patent wholly owned by Cingulate for CTx-1301.¹

Commercial preparation continues in parallel. On July 21, 2026, Cingulate signed an exclusive services agreement with Prasco, LLC to build distribution infrastructure for a potential CTx-1301 launch, including reach to roughly 19,000 independent and regional pharmacy accounts through Prasco's UNLIMIT program.¹ The company is also working with contract manufacturer Bend Bioscience to complete the requested CMC work and advance validation for material that would serve as launch inventory if approved.¹

On finances, Cingulate held approximately $28.4 million in cash and cash equivalents as of June 30, 2026, up from $11.0 million at the end of 2025.¹ The company said this is expected to fund operations into mid-2027, covering the remaining CMC work, the regulatory process for CTx-1301, and continued commercial buildout.¹