Cingulate targets May FDA decision for ADHD lead asset as capital runway extends

Cingulate (NASDAQ:CING) announced its fourth-quarter and full-year 2025 financial results alongside several critical regulatory milestones on March 18, 2026.

The clinical-stage biopharmaceutical company confirmed that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its lead candidate, CTx-1301, with a PDUFA action date set for May 31, 2026.

The company, which focuses on utilizing its proprietary Trimodal Delivery (TMD) platform to treat Attention Deficit Hyperactivity Disorder (ADHD), also secured key intellectual property protections.

Recent developments include a U.S. Notice of Allowance and a European patent for CTx-1301, strengthening the company's global commercial position ahead of potential approval.

Financially, Cingulate reported a net loss of $22.4 million for the 2025 fiscal year.

As of December 31, 2025, the company held approximately $11 million in cash and reported working capital of $1.7 million.

To fortify its balance sheet, Cingulate recently closed a $12 million "at-the-market" private investment in public equity (PIPE) financing.

Management anticipates that this capital infusion, combined with current resources, will provide sufficient liquidity to fund operations into late the fourth quarter of 2026.