---
schema_version: "secwatch.filing_event.v1"
accession: "0001824293-25-000160"
form_type: "8-K"
ticker: "GRI"
cik: "0001824293"
company_name: "GRI Bio, Inc."
filed_at: "2025-12-08T23:59:59+00:00"
generated_at: "2026-05-16T14:03:38.076405+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# GRI Bio reports positive Phase 2a data for GRI-0621 in IPF; primary endpoint met

## Summary
- Phase 2a trial (35 IPF subjects, 2:1 randomization) met primary safety endpoint; GRI-0621 well tolerated over 12 weeks with no treatment-related SAEs.
- Placebo-adjusted FVC increased 99 ml (all treated) and 139 ml (on top of standard of care); 39% of treated had FVC gain vs 80% decline on placebo.
- Serum biomarkers showed anti-fibrotic effect (decreased fibrosis markers, increased resolution markers) and alveolar basement membrane repair signals.
- Adverse events were grade 2 (17%) or grade 3 (4%); common: dry skin, dry lips, muscle pain; no cough or GI increase vs placebo.
- 80% of subjects on background pirfenidone/nintedanib; no changes in liver enzymes, triglycerides or cholesterol observed.

## SEC filing metadata
- accession: 0001824293-25-000160
- form_type: 8-K
- ticker: GRI
- cik: 0001824293
- company_name: GRI Bio, Inc.
- filed_at: 2025-12-08T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1824293/000182429325000160/0001824293-25-000160-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1824293/000182429325000160/val-20251208.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001824293-25-000160
- JSON: https://secwatch.observer/filing/0001824293-25-000160.json
- Plain text: https://secwatch.observer/filing/0001824293-25-000160.txt

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