Cingulate says FDA CRL for CTx-1301 cites CMC requests, no clinical safety or efficacy concerns

Cingulate, Inc.

Cingulate, Inc.

CING

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  • Cingulate received an FDA complete response letter for its CTx-1301 ADHD NDA on June 2, 2026.
  • The FDA cited Chemistry, Manufacturing and Controls information requests. No clinical safety or efficacy concerns were identified.
  • Management plans to submit the requested CMC information promptly. Work is underway with its manufacturing partner ahead of resubmission.
  • The company reported nearly USD 30 million in cash. It expects that to fund resubmission work, pre-commercial activities into 2027.


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