secwatch.observer — SEC 8-K summary
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Issuer:     GRI Bio, Inc. (GRI)
CIK:        0001824293
Form:       8-K
Filed at:   2026-09-08T12:16:17+00:00
Accession:  0001824293-26-000057
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1824293/000182429326000057/0001824293-26-000057-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1824293/000182429326000057/val-20260908.htm
  HTML page:      https://secwatch.observer/filing/0001824293-26-000057

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer