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Cyclerion Therapeutics Announces Progress Toward CYC-126 Phase 2 Proof-of-Concept Study with FDA Feedback and Formation of Clinical Advisory Board

–Received Positive Pre-Investigational New Drug (“IND”) Written Feedback from the U.S. Food and Drug Administration (“FDA”)– –Clinical Advisory Board (“CAB”) Includes Key Leaders across Neuropsychiatry, Anesthesiology, and Clinical Development – –Remain On Track to Initiate CYC-126's Phase 2 Proof-of-Concept (“POC”) Study in Treatment Resistant Depression (“TRD”) in the Second Half of 2026 – CAMBRIDGE, Mass., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) (“Cyclerion” or "Company”), a biopharmaceutical company pioneering neuropsychiatric therapies, today announced it has received positive written regulatory feedback and responses from the FDA on CYC-126's Phase 2 POC study in TRD and its path to potential regulatory approval.

Cyclerion Therapeutics Announces Strategic Agreement with Medsteer and Progress Toward Initiating Phase 2 Proof-of-Concept Study for CYC-126 in Treatment-Resistant Depression

– Cyclerion Strengthens Development of Closed-Loop Anesthetic Platform through Strategic Collaboration Agreement with Medsteer – – Comprehensive Business Update and Path to Initiating Phase 2 Proof-of-Concept (“POC”) Study in the Second Half of 2026 – – Webcast Being Held on January 6, 2026 at 8:00 a.m. ET, Featuring Key Opinion Leader, Dr. Husseini Manji – CAMBRIDGE, Mass.