---
schema_version: "secwatch.filing_event.v1"
accession: "0001824293-25-000167"
form_type: "8-K"
ticker: "GRI"
cik: "0001824293"
company_name: "GRI Bio, Inc."
filed_at: "2025-12-10T23:59:59+00:00"
generated_at: "2026-05-16T13:40:01.831573+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# GRI Bio announces positive Phase 2a topline results for GRI-0621 in IPF

## Summary
- Primary endpoint met: GRI-0621 well tolerated with no drug-related severe/serious adverse events; no GI increase vs placebo.
- Biomarkers improved: type VI collagen remodeling shifted from fibrogenic (+10%) to fibrolytic (-7%), suggesting fibrosis resolution.
- FVC improved: placebo-adjusted increase of 99ml (139ml with standard of care); 39% of GRI-0621 subjects gained FVC vs 80% of placebo declined.
- Type IV collagen remodeling shifted to neutral (0%) vs fibrolytic (-16%) in placebo, indicating alveolar basement membrane repair.

## SEC filing metadata
- accession: 0001824293-25-000167
- form_type: 8-K
- ticker: GRI
- cik: 0001824293
- company_name: GRI Bio, Inc.
- filed_at: 2025-12-10T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1824293/000182429325000167/0001824293-25-000167-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1824293/000182429325000167/val-20251210.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001824293-25-000167
- JSON: https://secwatch.observer/filing/0001824293-25-000167.json
- Plain text: https://secwatch.observer/filing/0001824293-25-000167.txt

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