Cingulate Inc.
PDUFA Confirmed
CTx-1301
ADHD
Resolved
37days ago
FDA decision Β· May 31, 2026
What's at stake The FDA's approval decision on CTx-1301 for ADHD is due May 31, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
β€œIn October 2025, Cingulate announced that the U.S. Food and Drug Administration (FDA) had accepted for review the New Drug Application (NDA) for CTx-1301 and had assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31”

Provenance

3 sources on file.

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