FDA Issues Complete Response Letter to Cingulate for ADHD Drug CTx-1301, Shares Rise

Cingulate Inc. (CING) shares advanced on June 2, 2026, after the Food and Drug Administration issued a Complete Response Letter for its attention-deficit/hyperactivity disorder treatment CTx-1301, requesting additional chemistry, manufacturing and controls data. The agency did not flag clinical safety or efficacy issues, signaling a narrower path to potential approval. Investors interpreted the limited scope of the CRL as a positive signal, pushing the stock higher. A CRL typically outlines deficiencies that must be resolved before a drug can be approved. In this case, the FDA is seeking further CMC information without requiring new clinical trials. Cingulate said it plans to address the requests and resubmit its application. The company is developing CTx-1301 as a once-daily, multi-dose stimulant designed to provide rapid onset and extended duration for ADHD patients.