Cingulate receives FDA Complete Response Letter for CTx-1301; no safety/efficacy issues, CMC-only

Cingulate Inc.

FDA issued a Complete Response Letter for CTx-1301 (dexmethylphenidate HCl) NDA for ADHD.
No current concerns about clinical safety or efficacy; CMC information requests identified.
Company expects prompt resubmission of requested CMC data; has ~$30M cash on hand.
NDA previously accepted with PDUFA target date of May 31, 2026.

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