---
schema_version: "secwatch.filing_event.v1"
accession: "0001824293-26-000057"
form_type: "8-K"
ticker: "GRI"
cik: "0001824293"
company_name: "GRI Bio, Inc."
filed_at: "2026-09-08T12:16:17+00:00"
generated_at: "2026-09-08T12:20:08.685167+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# GRI Bio reports positive Phase 2a IPF data for GRI-0621; FVC +99 mL vs placebo

## Summary
- Phase 2a (n=35) GRI-0621-IPF-02: placebo-adjusted FVC +99 mL at Week 12 overall, +139 mL on background SOC.
- FVC increase ≥30 mL in 39% of drug vs 20% placebo; 50% on SOC; decline ≥10% in 8% vs 20%.
- Nine mechanistic pillars supported by RNA-seq, flow cytometry, serum ECM; 18 transcripts FDR<0.05.
- No serious TEAEs (0% vs 8% placebo); less cough (0% vs 25%), dyspnea (4% vs 17%), diarrhea (17% vs 33%).
- Company plans 52-week study; data presented at ERS 2026.

## SEC filing metadata
- accession: 0001824293-26-000057
- form_type: 8-K
- ticker: GRI
- cik: 0001824293
- company_name: GRI Bio, Inc.
- filed_at: 2026-09-08T12:16:17+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1824293/000182429326000057/0001824293-26-000057-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1824293/000182429326000057/val-20260908.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001824293-26-000057
- JSON: https://secwatch.observer/filing/0001824293-26-000057.json
- Plain text: https://secwatch.observer/filing/0001824293-26-000057.txt

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