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. (NASDAQ: INMB) is a clinical-stage biotechnology company that regularly issues news and updates about its inflammation and immunology pipeline targeting the innate immune system. This news page aggregates company press releases and third-party coverage related to INmune Bio’s DN-TNF platform, CORDStrom™ mesenchymal stromal cell platform, and INKmune® natural killer cell priming platform.
Readers can find updates on XPro™ (XPro1595, pegipanermin), a selective soluble TNF neutralizer that the company is developing for neurological diseases driven by chronic inflammation. Recent news has highlighted Phase 2 MINDFuL trial results in early Alzheimer’s disease with inflammatory biomarkers, neuroimaging analyses using advanced MRI techniques, and manuscript submissions to peer-reviewed journals. The company also reports on scientific presentations at conferences such as the Clinical Trials on Alzheimer’s Disease (CTAD) meeting and the Alzheimer’s Association International Conference.
News related to the CORDStrom™ cell therapy platform includes clinical and manufacturing milestones in recessive dystrophic epidermolysis bullosa (RDEB), such as completion of a blinded randomized trial, pilot-scale commercial manufacturing runs at a cell and gene therapy manufacturing center in the United Kingdom, and intellectual property developments. INmune Bio also issues updates on participation in industry events and panels focused on dermatologic rare diseases and cell therapy manufacturing.
For the INKmune® platform, news items cover progress in the CaRe PC Phase I/II trial in metastatic castration-resistant prostate cancer, including reports that the trial met its primary and certain secondary endpoints, safety observations, and biomarker findings related to NK cell activation. Corporate news, including financing transactions, management changes, and special stockholder meetings, is also disclosed through regular press releases and corresponding SEC filings. Investors and researchers can use this page to follow INMB news on clinical data, regulatory plans, manufacturing scale-up, and corporate developments.
INmune Bio (NASDAQ: INMB) received FDA minutes confirming alignment on an integrated Phase 2b/3 registration pathway for XPro1595 in early Alzheimer’s disease. The FDA raised no objection to a single master protocol, ~300-participant Phase 2b (9-month assessment), ~1,000-participant full program with an 18-month Phase 3, CDR-SB as sole primary endpoint, and a ~20% non-enriched exploratory cohort.
The FDA supported an inflammation-based biomarker enrichment strategy and allowed final powering and statistical plans to be specified in the protocol to be submitted for review.
INmune Bio (NASDAQ: INMB) submitted a pre-submission package for CORDStrom to the UK MHRA on February 10, 2026, seeking early scientific and regulatory feedback to streamline a full MAA.
The company reported MissionEB trial improvements in itch, pain, skin integrity and QoL, three commercial pilot manufacturing runs meeting release criteria in Stevenage, and plans to file an MAA mid-summer 2026 with EU and U.S. submissions targeted for Q4 2026. CORDStrom holds U.S. Orphan Drug and Rare Pediatric Disease designations; recent legislation reauthorizes the FDA Rare Pediatric Disease PRV program through 9/30/2029.
INmune Bio (NASDAQ: INMB) CEO David Moss reviewed 2025 progress and outlined 2026 priorities, highlighting clinical and regulatory milestones for two lead programs: CORDStrom for recessive dystrophic epidermolysis bullosa (RDEB) and XPro (XPro1595) for Alzheimer’s disease. Key 2025 items include three commercial pilot-scale manufacturing runs for CORDStrom, a planned MAA submission in mid‑summer 2026 to the UK MHRA and a targeted BLA submission late 2026 to FDA (timelines subject to regulatory feedback). XPro’s Phase 2 MINDFuL showed biomarker‑defined signals (EMACC effect size 0.27) guiding a precision‑medicine registrational path. Cash and equivalents were approximately $27.7M as of Sept 30, 2025, with financing and rebates expected to fund operations through year‑end 2026.
INmune Bio (NASDAQ: INMB) announced a peer-reviewed overview on mesenchymal stromal cell (MSC) therapies published in Cytotherapy, titled “Fate and Function of Exogenously Administered MSCs: Current Insights and Future Directions.”
Lead scientist on INmune’s CORDStrom™ R&D, Dr Nikita M. Patel, was one of the senior authors on an invitation-only working party that reviewed current knowledge and gaps for MSC development. Topics included systemic delivery, local/depot delivery (the CORDStrom™ approach), and in vivo persistence. The company said it is initially developing CORDStrom™ for RDEB and expects to file a BLA and MAA in 2026.
INmune Bio (NASDAQ: INMB) reported new Phase 2 neuroimaging analyses from the MINDFuL trial of XPro1595 in early Alzheimer’s disease patients with elevated neuroinflammation (ADi). Presented at CTAD Dec 1-4, 2025, the PerpPD+ grey-matter MRI analysis showed a trend toward slowed progression of cortical disarray in XPro1595-treated, dose-compliant ADi participants at 24 weeks.
The company says these imaging signals align with directional improvements in biological, cognitive, and neuropsychiatric endpoints and that additional MRI analyses are expected in 2026.
INmune Bio (NASDAQ: INMB) will present two scientific posters at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) in San Diego on Dec 1–4, 2025. The company will present Phase 2 MINDFuL results for XPro1595 (a selective soluble TNF neutralizer) during a session running from 3:30 PM Dec 1 to 5:30 PM Dec 2 PT at location P057 with presenting author Kim A. Staats, PhD. A second presentation, led by Sarah Barnum, PhD of Cognition Metrics, will report validation work on the Early Mild Alzheimer’s Cognitive Composite (EMACC) and its associations with blood biomarkers on Dec 4, 2025 at location P316.
INmune Bio (NASDAQ: INMB) reported Q3 2025 results and operational milestones on October 30, 2025. The company posted a net loss of $6.5M vs $12.1M in Q3 2024 and held $27.7M cash as of September 30, 2025, with ~26.6M shares outstanding as of October 30, 2025.
Clinical progress: completed two pilot-scale CORDStrom manufacturing runs with an MAA planned mid-2026 and anticipated subsequent BLA; XPro1595 (DN-TNF) Phase 2 MINDFuL data show clinical benefits in an amyloid-positive, high-inflammation subgroup and an excellent safety profile; INKmune CARE-PC met its primary endpoint and two secondary endpoints with final data pending.
INmune Bio (NASDAQ: INMB) will report third-quarter 2025 financial results and provide a corporate update on Thursday, October 30, 2025. Management will host a conference call and live audio webcast at 4:30 PM Eastern Time to discuss results for the quarter ended September 30, 2025.
Dial-in details: domestic 1-800-225-9448, international 1-203-518-9708, Conference ID: INMUNE. The live webcast is available at the company webcast link. A transcript will be posted ~24 hours after the call. A replay is available through November 13, 2025 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN 11159914.
INmune Bio (NASDAQ: INMB) announced that CEO David Moss will participate in a Dermatologic Rare Disease Panel at the Maxim Growth Summit on October 22, 2025 in New York City.
The panel is moderated by Jason McCarthy, Ph.D. and Mr. Moss will discuss INmune Bio’s CORDStrom™ advanced cell platform for treating Recessive Dystrophic Epidermolysis Bullosa (RDEB). Mr. Moss will be available for one-on-one meetings during the conference. Event dates: Oct 22–23, 2025; panel time: Oct 22, 8:30am ET. Registration information is provided on the event page.
INmune Bio (NASDAQ: INMB) has submitted results from its Phase 2 MINDFuL trial of XPro™ in Alzheimer's disease to npj Dementia journal. While the trial did not meet its primary endpoint in the overall population, it showed promising results in a specific subgroup of patients with both amyloid pathology and high inflammatory burden (ADi population).
Key findings in the ADi population demonstrated positive trends across cognitive, neuropsychiatric, and biological endpoints. Notably, XPro™ showed a complete absence of amyloid-related imaging abnormalities (ARIA), a common side effect in other Alzheimer's treatments, even in high-risk patients including APOE4 carriers. The company expects FDA regulatory feedback in Q1 2026.
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