---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-26-056599"
form_type: "8-K"
ticker: "INMB"
cik: "0001711754"
company_name: "Inmune Bio, Inc."
filed_at: "2026-05-14T20:05:34+00:00"
generated_at: "2026-05-14T21:01:31.523135+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA grants Fast Track designation to INmune Bio's XPro for early Alzheimer's disease

## Summary
- Fast Track covers XPro for early Alzheimer's disease (MCI due to AD and mild AD dementia).
- XPro is a selective soluble TNF inhibitor targeting neuroinflammation; no approved therapy targets this pathway.
- Designation provides more frequent FDA interactions and eligibility for Rolling Review.
- Phase 2b/3 registrational trial planned as seamless adaptive design using EMACC and pTau217.

## SEC filing metadata
- accession: 0001213900-26-056599
- form_type: 8-K
- ticker: INMB
- cik: 0001711754
- company_name: Inmune Bio, Inc.
- filed_at: 2026-05-14T20:05:34+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1711754/000121390026056599/0001213900-26-056599-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1711754/000121390026056599/ea0290846-8k_inmune.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-26-056599
- JSON: https://secwatch.observer/filing/0001213900-26-056599.json
- Plain text: https://secwatch.observer/filing/0001213900-26-056599.txt

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