INmune Bio

INMB

Market cap $52.1M

Commercial-Ready Manufacturing Now Supports Planned Phase 3 Confirmation Trial, and US, EU and UK Regulatory Submissions for Future Commercial Supply. Company Expresses Support for MHRA Draft Rare Disease Therapies Regulatory Framework BOCA RATON, Fla, July 20, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced a significant manufacturing milestone for its CORDStrom™ platform.

The study points to soluble TNF as a key biological link between head injury and Alzheimer's disease and shows that selectively neutralizing it with XPro1595 prevents the injury-induced rise in amyloid pathology while improving early cognitive and pain-related outcomes.

Advanced MRI analyses showed early treatment-related changes in white matter myelin integrity and cortical microstructure at Week 24, supporting biologic activity of selective soluble TNF inhibition.

Secures Global Framework for Composition-of-Matter and Method-of-Treatment Claims Covering Lead Program Ebstrocel for Epidermolysis Bullosa and Next-Generation Engineered Modalities Extending to 2045

Approval of pediatric strategy validates clinical data package and accelerates the regulatory path for CORDStrom™ in the United Kingdom

MHRA minutes from May 12 pre-MAA Scientific Advice meeting confirm agreement across all questions covering CMC, non-clinical and clinical evidence packages   MHRA pediatric feedback recognizes MissionEB Phase 2 data as demonstrating clinically meaningful symptomatic benefit, particularity pain and pruritis, and states the data could support positioning as chronic or intermittent supportive therapy for RDEB BOCA RATON, Fla, June 23, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced that it has received official, accepted meeting minutes from its recent face-to-face pre-Marketing Authorization Application (pre-MAA) Scientific Advice meeting with the UK Medicines & Healthcare products Regulatory Agency (MHRA) for CORDStrom™ (Ebstrocel™) in Recessive Dystrophic Epidermolysis Bullosa (RDEB). The May 12, 2026, meeting resulted in written alignment across all questions submitted by the Company and provides a clear regulatory path for INmune Bio's planned 2026 UK Marketing Authorization Application (MAA) seeking Conditional Marketing Authorization for Ebstrocel™ in RDEB.

XPro1595 showed a highly significant treatment effect in the full mITT population (p=0.0028; d=0.46; n=200), demonstrating broad tissue-level target engagement and treatment-related biological effect.

Boca Raton, FL, May 15, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB), a clinical-stage biotechnology company developing therapies that target innate immune dysfunction, today announced that results from its Phase 2 MINDFuL trial in Alzheimer's disease have been published in the peer-reviewed journal NPJ Dementia. The study evaluated the safety, biomarker engagement, and clinical efficacy of XPro™ (XPro1595, pegipanermin) in patients with mild Alzheimer's disease characterized by biomarkers of inflammation. In a pre-specified analysis of the protocol-defined Alzheimer's Disease with inflammation (ADi) subgroup, XPro™ showed directionally consistent benefit across cognitive, global, functional, behavioral, and biomarker endpoints over 24 weeks, with no amyloid-related imaging abnormalities (ARIA) observed.

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.

Alliance launches with 26 founding companies to develop a national strategy for U.S. biotechnology leadership BOCA RATON, Fla., May 13, 2026 (GLOBE NEWSWIRE) -- INmune Bio, a clinical-stage biotechnology company developing treatments that harness the patient's innate immune system to fight disease, today announced it has been named a founding member of the American Biotech Innovation Alliance (ABIA).