---
schema_version: "secwatch.filing_event.v1"
accession: "0001824293-26-000050"
form_type: "8-K"
ticker: "GRI"
cik: "0001824293"
company_name: "GRI Bio, Inc."
filed_at: "2026-06-18T20:50:36+00:00"
generated_at: "2026-06-18T20:52:11.660244+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# GRI Bio receives FDA Orphan Drug Designation for GRI-0621 in IPF

## Summary
- FDA granted Orphan Drug Designation to GRI-0621 for idiopathic pulmonary fibrosis.
- Designation provides potential 7-year U.S. market exclusivity upon approval.
- GRI-0621 is an oral RARβ/γ selective agonist that met endpoints in Phase 2a trial (35 patients).
- IPF affects fewer than 200,000 U.S. patients; significant unmet medical need exists.

## SEC filing metadata
- accession: 0001824293-26-000050
- form_type: 8-K
- ticker: GRI
- cik: 0001824293
- company_name: GRI Bio, Inc.
- filed_at: 2026-06-18T20:50:36+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1824293/000182429326000050/0001824293-26-000050-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1824293/000182429326000050/val-20260618.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001824293-26-000050
- JSON: https://secwatch.observer/filing/0001824293-26-000050.json
- Plain text: https://secwatch.observer/filing/0001824293-26-000050.txt

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