---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-053035"
form_type: "8-K"
ticker: "CYCN"
cik: "0001755237"
company_name: "Cyclerion Therapeutics, Inc."
filed_at: "2026-02-17T23:59:59+00:00"
generated_at: "2026-05-16T02:28:57.936587+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-26-053035
- form_type: 8-K
- ticker: CYCN
- cik: 0001755237
- company_name: Cyclerion Therapeutics, Inc.
- filed_at: 2026-02-17T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1755237/000119312526053035/0001193125-26-053035-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1755237/000119312526053035/d104475d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-053035
- JSON: https://secwatch.observer/filing/0001193125-26-053035.json
- Plain text: https://secwatch.observer/filing/0001193125-26-053035.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.