---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-106699"
form_type: "8-K"
ticker: "VYNE"
cik: "0001566044"
company_name: "VYNE Therapeutics Inc."
filed_at: "2026-09-10T20:01:38+00:00"
generated_at: "2026-09-10T20:04:20.752890+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Yarrow Bioscience advances YB-101: FDA Fast Track, Phase 2a/2b trial started

## Summary
- In-licensed YB-101 (anti-TSHR antibody) from GenSci in Dec 2025 for Graves' disease and thyroid eye disease outside China.
- FDA cleared IND for GD in March 2026; Fast Track designation granted May 20, 2026.
- Initiated combined Phase 2a/2b trial in June 2026; Phase 2a data expected H2 2027.
- Merger with Yarrow Bioscience Operating Company Corp. (formerly Yarrow Bioscience, Inc.) reflected in business update.

## SEC filing metadata
- accession: 0001104659-26-106699
- form_type: 8-K
- ticker: VYNE
- cik: 0001566044
- company_name: VYNE Therapeutics Inc.
- filed_at: 2026-09-10T20:01:38+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1566044/000110465926106699/0001104659-26-106699-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1566044/000110465926106699/tm2624937d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-106699
- JSON: https://secwatch.observer/filing/0001104659-26-106699.json
- Plain text: https://secwatch.observer/filing/0001104659-26-106699.txt

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