GRI Bio, Inc. — Form 8-K
Filed September 8, 2026 · analyzed by the 8-K Agent
8-K
▲ Likely positive
significance 72/100
What the filing says
GRI Bio (market cap ~$1.5M) announced Phase 2a results for GRI-0621, an oral RAR-beta/gamma agonist, in 35 IPF patients (23 active, 12 placebo) over 12 weeks. Key findings: placebo-adjusted FVC change +99 mL overall, +139 mL on background SOC; 39% of treated patients showed FVC increase ≥30 mL vs. 20% placebo; 0% treatment-related serious adverse events vs. 8% placebo; 0% cough (vs. 25% placebo), 17% diarrhea (vs. 33% placebo). Nine mechanistic pillars supported across four independent modalities (RNA-seq, serum biomarkers, flow cytometry, clinical). Study not powered for efficacy; adaptive Phase 2b/3 planned next.
Why this rating
Pivotal Phase 2a readout de-risks lead program for $1.5M biotech; positive safety, mechanism concordance, and FVC signals support Phase 2b/3 advancement in $6–9B IPF market. Moderate relative to company size but transformational if efficacy holds in pivotal trial.
Tradability signal
NO TRADE
No trade: only ~$0k traded in the last 30 min — too illiquid to enter and exit.
Derived from this site's own measured outcomes + live price/liquidity at analysis time. An experiment, not investment advice.
Price action (we called it positive)
before filing · preread $2.71 ▼ 5.90% | at our read · unknown $2.88 | +10 min · unknown $2.88 ▲ 0.00% | +30 min · unknown $2.88 ▲ 0.00% | +1 hr pending | +4 hrs pending |
The stock had already moved +6.27% between hitting EDGAR and our read finishing — deltas above are measured from our read.
Quotes via Yahoo Finance at capture time; sessions other than regular hours are labeled. Not investment advice. How accurate are our calls? →
See more from September 8, 2026.
EDGAR·FLOW summarizes public SEC EDGAR filings with automated analysis. Materiality scores and stock-impact predictions are algorithmically generated and are not investment advice. Always verify against the source filing on SEC.gov.