Cyclerion receives positive FDA feedback for CYC-126 Phase 2 POC study in TRD; remains on track for 2H 2026 initiation

Cyclerion Therapeutics, Inc.

Received positive pre-IND written feedback from FDA supporting CYC-126 Phase 2 POC study design in treatment-resistant depression (TRD).
Remains on track to initiate Phase 2 POC study in 2H 2026; first patient in Australia, U.S. enrollment in 1H 2027.
Formed Clinical Advisory Board with five key leaders in neuropsychiatry, anesthesiology, and clinical development.
Selected contract research organization to support multinational study execution.

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