FDA Declines Approval for Cingulate ADHD Drug Treatment
The FDA issued a complete response letter for Cingulate's ADHD candidate CTx-1301 citing manufacturing issues rather than safety or efficacy. The company plans to address the requests quickly and expects its 30 million dollars in cash to support operations into 2027.
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CINGULATE INC shares face pressure after the United States Food and Drug Administration (FDA) declined to approve its ADHD treatment, CTx-1301, on Tuesday afternoon. The regulator cited manufacturing-related concerns rather than issues with the drug's safety or clinical effectiveness. This delay forces the developer to burn through cash reserves as it navigates a crowded market of established competitors.
