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INmune Bio Receives FDA Fast Track Designation for XPro1595 in Early Alzheimer's Disease
BOCA RATON, FL, May 14, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB), a late-stage biotechnology company focused on inflammation and immunology,
About this update from Inmune Bio Inc.
[{"type":"text","content":"BOCA RATON, FL, May 14, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB), a late-stage biotechnology company focused on inflammation and immunology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to XPro™ (pegipanermin), the company's first-in-class selective soluble TNF inhibitor, for the treatment of early Alzheimer's disease (AD). The designation specifically covers XPro™ for treatment of early Alzheimer's disease encompassing both mild cognitive impairment (MCI) due to AD and mild Alzheimer’s disease dementia, which represents a large and growing population. \"Receiving Fast Track designation from the FDA is a transformative milestone for XPro’s development program,\" said David Moss, CEO of INmune Bio. \"This recognition underscores the urgent need for innovative treatments that address the underlying neuroinflammation associated with early Alzheimer’s. We believe XPro™ has the potential to significantly alter the trajectory of this devastating disease, and we look forward to working more closely with the FDA to bring this therapy to patients as efficiently as possible.\" Fast Track designation is intended to facilitate development and expedite review of drugs that treat serious conditions and have potential to address an unmet medical need. Inflammation in the brain is now recognized as an independent, early driver of cognitive decline in Alzheimer's disease, and no approved therapy targets these inflammatory pathways. Soluble tumor necrosis factor (sTNF) is believed to be a key mediator of neuroinflammation associated with disease progression in Alzheimer’s disease. XPro™ selectively neutralizes sTNF while preserving the immune functions that protect and repair the brain. The designation provides opportunities for more frequent interactions with FDA and, if relevant criteria are met, eligibility for Rolling Review and other expedited review mechanisms. \"As clinicians, we see every day the consequences of having limited disease-modifying options for patients with early Alzheimer's disease, especially those whose biology suggests inflammation is actively driving their decline,\" said Sharon Cohen, M.D., FRCPC, Behavioral Neurologist and Medical Director of the Toronto Memory Program, and a MINDFuL trial investigator. \"The Fast Track designation for XPro™ is encou...