secwatch.observer — SEC 8-K summary
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Issuer:     GRI Bio, Inc. (GRI)
CIK:        0001824293
Form:       8-K
Filed at:   2026-01-08T23:59:59+00:00
Accession:  0001824293-26-000002
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

GRI Bio reports positive Phase 2a immune data for GRI-0621 in IPF
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- Phase 2a data shows GRI-0621 reduces pro-fibrotic cytokines (IL-4, IL-13, IL-17A, IL-22, TGF-β) and increases anti-fibrotic IFN-γ in BAL and PBMC after 12 weeks.
- Study met primary safety/tolerability endpoint; secondary endpoints suggest fibrosis reversal and lung repair, with twice as many subjects with no FVC decline vs standard of care.
- 35 subjects enrolled, 2:1 randomized to GRI-0621 4.5mg or placebo for 12 weeks; sub-study in 8 subjects examines immune cells in BAL fluid.
- Company believes stockholders' equity exceeds $2.5M Nasdaq minimum after December 2025 public offering.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1824293/000182429326000002/0001824293-26-000002-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1824293/000182429326000002/val-20260108.htm
  HTML page:      https://secwatch.observer/filing/0001824293-26-000002

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