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

Inmune Bio, Inc.

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.

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