Welcome to our dedicated page for Inmune Bio news (Ticker: INMB), a resource for investors and traders seeking the latest updates and insights on Inmune Bio stock.
INmune Bio Inc. develops clinical-stage immunology and biotechnology treatments designed to target the innate immune system in disease. Company news commonly centers on three platforms: CORDStrom, a pooled allogeneic human umbilical cord-derived mesenchymal stromal/stem cell platform; XPro, a dominant-negative TNF platform intended to selectively neutralize soluble TNF; and INKmune, a cell-based medicine designed to prime natural killer cells against residual cancer.
Recurring updates include clinical and preclinical data, regulatory pathway discussions, manufacturing and collaboration agreements, conference presentations, shareholder communications, and quarterly or annual financial results. Coverage also reflects program areas such as recessive dystrophic epidermolysis bullosa, early Alzheimer’s disease, neuroinflammation, inflammatory disease and oncology.
INmune Bio (NASDAQ: INMB) has advanced its CORDStrom™ mesenchymal stromal cell (MSC) platform patent application into the U.S. national phase, a key step in its global IP strategy. The application covers lead program Ebstrocel for epidermolysis bullosa and next-generation engineered MSC modalities, with potential exclusivity to at least 2045, supported by a favorable international PCT Written Opinion on patentability.
INmune Bio (NASDAQ: INMB) received UK MHRA approval of the Pediatric Investigation Plan (PIP) for Ebstrocel, part of the CORDStrom platform, in Recessive Dystrophic Epidermolysis Bullosa (RDEB). This is the first required step toward a 2026 UK Marketing Authorization Application and an early 2027 US Accelerated Approval filing.
The MHRA completed review in under three months, raised no objections to the clinical data or claims, and aligned with the company’s CMC, non-clinical, clinical and post-marketing trial strategy, which INmune Bio views as significantly reducing regulatory uncertainty.
INmune Bio (NASDAQ:INMB) received written alignment from the UK MHRA following a May 12, 2026 pre-MAA meeting for CORDStrom™/Ebstrocel™ in recessive dystrophic epidermolysis bullosa (RDEB). The advice supports a planned 2026 UK Conditional Marketing Authorization application and clarifies CMC, non-clinical, and rare-disease clinical evidence expectations.
MHRA feedback acknowledges MissionEB Phase 2 data as showing clinically meaningful symptomatic benefit, particularly in pain and pruritus, while noting limits in durable wound closure. Guidance will shape a confirmatory Phase 3 trial, manufacturing transition, and future EMA and FDA filings targeted for late 2026 or early 2027.
INmune Bio (NASDAQ: INMB) reported statistically significant effects of XPro1595 on a white matter myelin MRI biomarker in the Phase 2 MINDFuL Alzheimer’s trial. In the full mITT population (n=200), p=0.0028 (Cohen’s d=0.46); in biomarker-enriched patients (n=100), p=0.0098 (d=0.59).
The data support target engagement, a precision-medicine strategy in inflammation-positive early Alzheimer’s, and align with an FDA‑backed Phase 2b/3 registrational pathway, Fast Track designation, and a favorable safety profile with no observed ARIA‑E or ARIA‑H.
INmune Bio (NASDAQ: INMB) reported that Phase 2 MINDFuL trial results of XPro™ in mild Alzheimer’s disease were published in peer-reviewed journal NPJ Dementia. The study assessed safety, biomarker engagement and clinical efficacy in inflammation-defined patients.
In a pre-specified ADi subgroup, XPro™ showed directionally consistent benefits across multiple clinical and biomarker endpoints over 24 weeks, with no ARIA observed, supporting a biomarker-enriched strategy and future Phase 3 development of the XPro platform.
INmune Bio (NASDAQ: INMB) received FDA Fast Track designation for XPro (pegipanermin), a selective soluble TNF inhibitor, to treat early Alzheimer's disease, covering MCI due to AD and mild Alzheimer's dementia.
The designation enables closer FDA interaction as INmune advances a precision-medicine Phase 2b/3 registrational program in high-risk early-stage patients.
INmune Bio (NASDAQ: INMB) reported Q1 2026 results and operational milestones on May 7, 2026. Key highlights: net loss $5.4M, R&D $3.6M, G&A $2.2M, and ~26.6M shares outstanding as of May 7, 2026.
Clinical progress: CORDStrom MAA to the UK MHRA mid-summer, follow-on EMA and planned FDA BLA in Q4 2026; XPro advanced to adaptive Phase 2b/3 for early Alzheimer’s; ongoing imaging analyses and preclinical INB03 data reported.
INmune Bio (NASDAQ: INMB) and Anthony Nolan signed an amended and restated Material Transfer and License Agreement effective April 29, 2026 to expand long‑term supply of umbilical cord tissue for the CORDStrom™ MSC platform.
The collaboration targets Recessive Dystrophic Epidermolysis Bullosa (RDEB), oncology (CORDStrom‑TRAIL), osteoarthritis, and systemic lupus erythematosus, and includes GMP, HTA traceability, and global regulatory compliance provisions.
American Biotech Innovation Alliance (ABIA) launched on May 5, 2026, with 21 founding member companies to develop a national biotech innovation strategy addressing regulatory policy, capital formation, manufacturing, and workforce development.
ABIA will convene leaders across U.S. regions to produce a flagship report and actionable recommendations for policymakers and industry stakeholders.
INmune Bio (NASDAQ: INMB) will report first-quarter 2026 results and host a corporate update via conference call and webcast on May 7, 2026 at 4:30 PM ET. Management will discuss the quarter ended March 31, 2026; a transcript and replay will be available after the call.
Dial-in numbers, conference ID INMUNE, and a live webcast link are provided; the replay is available through May 21, 2026.