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

PUBT·06/02/2026 12:13:10

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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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cingulate Inc. published the original content used to generate this news brief on June 02, 2026, and is solely responsible for the information contained therein.

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