8-K - Cyclerion Therapeutics, Inc. | StockGist

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Cyclerion Therapeutics announced positive pre-IND FDA feedback supporting the Phase 2 proof-of-concept study design for CYC-126 in treatment-resistant depression and formed a Clinical Advisory Board with five key leaders in neuropsychiatry, anesthesiology, and clinical development. The company remains on track to initiate the Phase 2 study in the second half of 2026.

Key Takeaways

1Received positive pre-IND written feedback from FDA on CYC-126 Phase 2 POC study in TRD

2FDA supported advancement of planned Phase 2 study design using FDA-approved anesthetics

3Phase 2 POC study to initiate in H2 2026 with first patient in Australia and U.S. enrollment in H1 2027

4Formed Clinical Advisory Board with Dr. Husseini Manji, Dr. Linda Carpenter, Dr. Lawrence Olanoff, Dr. Yuriy Bronshteyn, and Dr. Laeben C. Lester

5Selected contract research organization for multinational Phase 2 study execution

6CYC-126 regulated under FDA CDER with CDRH input as applicable

Current Report Details

Event Type

Regulation Fd

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchang

Regulation Fd

9.01

. Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release, dated February 17, 2026. 104 Cover Page Interactive Data File (for

Exhibits Only

Source Document

Exhibits (2)

8-K

99.1

EX-99.1