Cyclerion Therapeutics Announces Progress Toward CYC-126 Phase 2 Proof-of-Concept Study with FDA Feedback and Formation of Clinical Advisory Board
Cyclerion Therapeutics, Inc. (CYCN)
Company Research
Source: GlobeNewswire
–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. CYC-126 is a potentially novel anesthetic-based investigational therapy that incorporates real-time electroencephalogram (“EEG”) feedback and is being developed for the treatment of TRD. CYC-126 is designed to be an individ
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Sec Filings
- 2/17/26 - Form 8-K
- 1/6/26 - Form 8-K
- CYCN's page on the SEC website