INmune Bio Receives FDA Meeting Minutes on XPro1595
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 12 2026
0mins
Should l Buy INMB?
INmune Bio announced that it received the official minutes from its End-of-Phase 2 meeting with the U.S. Food and Drug Administration, FDA. The minutes confirm regulatory alignment on the Company's proposed integrated Phase 2b/3 clinical development strategy for XPro1595 in early Alzheimer's Disease. "The outcome of the End-of-Phase 2 interaction is an important inflection point for XPro1595," said CJ Barnum, PhD, Vice President of Neuroscience at INmune Bio. "The FDA's feedback on our enrichment-led design, primary endpoint, and integrated Phase 2b/3 structure validates our scientific and clinical strategy and provides a clearly defined regulatory path to advancing XPro1595 into a registration-intent program in early Alzheimer's disease."
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Analyst Views on INMB
Wall Street analysts forecast INMB stock price to rise
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Moderate Buy
Current: 1.390
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Current: 1.390
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Averages
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About INMB
INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. The Company has three product platforms. The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF. DN-TNF product candidates are in clinical trials to determine if they can treat Mild Alzheimer’s disease, Mild Cognitive Impairment and treatment-resistant depression (XPro). The Natural Killer Cell Priming Platform includes INKmune, developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer and is in trials in metastatic castration-resistance prostate cancer. The third program, CORDStrom, is a proprietary pooled, allogeneic, human umbilical cord-derived mesenchymal Stromal/Stem cell (hucMSCs) platform that has completed a trial in recessive dystrophic epidermolysis bullosa.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
INmune Bio Hosts Webinar on Alzheimer's Treatment Pathway
- Clinical Trial Progress: Following the completion of the MINDFuL Phase 2 trial, INmune Bio has received FDA feedback supporting the advancement of XPro1595 to a registrational study in Alzheimer's patients, marking a significant milestone in early Alzheimer's treatment.
- Webinar Topics: The upcoming webinar will focus on three core topics: MINDFuL trial results, registrational study design, and FDA feedback, aiming to provide participants with in-depth insights into the clinical and commercial potential of XPro™.
- Expert Participation: The webinar will feature renowned clinical experts from Australia and Canada who will share their experiences and insights from the MINDFuL trial, further enhancing the company's authority in Alzheimer's research.
- Global Partnership Strategy: INmune Bio plans to maximize XPro™'s clinical and commercial potential through global partnerships, accelerating its development for Alzheimer's patients, which reflects the company's keen insight into market demands.
See More
INmune Bio to Host CORDStrom Webinar on RDEB Treatment
- Clinical Trial Results: INmune Bio will host a webinar on February 26, 2026, to share the latest clinical trial results of CORDStrom for treating recessive dystrophic epidermolysis bullosa (RDEB), particularly its systemic disease-modifying capabilities, which is expected to attract significant attention.
- Efficacy Data Presentation: The webinar will highlight new data on CORDStrom's impact on key clinical benchmarks such as improvements in EBDASI skin scores, weight gain in pediatric patients, and reductions in clinical symptoms, showcasing its potential to enhance patients' quality of life.
- Expert Participation: The event will feature firsthand clinical observations from principal investigators of the MissionEB trial, including UK dermatology expert Dr. Anna Martinez and INmune Bio's Chief Scientific Officer Prof. Mark Lowdell, adding credibility to the discussions.
- CORDStrom Platform Overview: CORDStrom is a patent-pending cell medicine derived from human umbilical cord mesenchymal stem cells, designed to provide high-quality, consistent treatment options with broad potential indications, which may play a crucial role in treating complex inflammatory and autoimmune diseases.
See More
INmune Bio Receives FDA Support for Alzheimer’s Therapy
- FDA Meeting Minutes Confirmed: INmune Bio received FDA meeting minutes confirming regulatory alignment on its XPro1595 development plan for early Alzheimer’s disease, leading to a more than 6% rise in pre-market trading.
- Precision Medicine Strategy Endorsed: The FDA endorsed INmune Bio's precision medicine strategy, which employs an enrichment-led trial design to identify patients closely linked to soluble TNF signaling, enhancing treatment efficacy and targeting.
- Clinical Data Foundation Established: The FDA's assessment was based on the company's Phase 2 data package, which included cognitive and biomarker findings from the selected patient population, establishing a solid foundation for subsequent trials.
- Future Research Planning: The Phase 2 evaluation period will last nine months, aimed at building a clinical foundation for the upcoming Phase 3 study, further advancing the development of XPro1595.
See More
INmune Bio Publishes Overview on Future Applications of MSC Therapies
- MSC Therapy Outlook: INmune Bio recently published an overview in the journal Cytotherapy regarding mesenchymal stromal cell (MSC) therapies, highlighting their potential applications in inflammation, immunomodulation, and wound healing, showcasing the company's forward-looking research capabilities in cell therapy.
- CORDStrom™ Platform Progress: The review, led by INmune's Chief Scientist Dr. Nikita M. Patel, discusses systemic and local delivery methods for the CORDStrom™ platform, with plans to file a Biologics License Application (BLA) and Marketing Authorization Application (MAA) in 2026, laying the groundwork for future clinical applications.
- Strengthening Scientific Foundation: The article summarizes the current knowledge base and critical gaps in MSC therapies, aiming to propose experimental questions to enhance the development of the CORDStrom™ platform, indicating INmune's leadership in advancing MSC research.
- Clinical Research Potential: INmune Bio's CORDStrom™ platform utilizes human umbilical cord-derived mesenchymal stromal cells to provide high-quality, reproducible cellular medicines, which may have a significant impact on treating complex inflammatory and autoimmune diseases.
See More
INmune Bio Presents New XPro1595 Data for Alzheimer's Disease at CTAD
- Clinical Trial Progress: INmune Bio presented new neuroimaging data for XPro1595 at the CTAD conference, indicating the drug may slow neurodegenerative progression in early Alzheimer's patients, highlighting its potential in treating inflammation-driven Alzheimer's disease.
- Biomarker Validation: Utilizing PerpPD+ imaging analysis, the study observed a trend towards reduced cortical disarray in patients with high inflammatory burden receiving XPro1595, further validating its mechanism of selectively neutralizing soluble TNF (sTNF).
- Market Opportunity: The findings underscore the unmet medical need for inflammation-driven Alzheimer's disease, positioning XPro1595 as a first-in-class disease-modifying therapy that could present significant commercial opportunities for the company.
- Future Data Outlook: INmune Bio confirmed that additional MRI analyses will be released in 2026, expected to provide further insights into XPro1595's impact on brain tissue in Alzheimer's patients, enhancing its competitive position in the market.
See More
INmune Bio Successfully Completes Initial Commercial Pilot-Scale Production of CORDStrom™ at CGT Catapult
Successful Manufacturing Milestone: INmune Bio Inc. has completed its first full-scale pilot commercial manufacturing run of CORDStrom™, a mesenchymal stromal cell therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB), at the Cell and Gene Therapy Catapult in the UK, paving the way for regulatory submissions in 2026.
Promising Clinical Results: CORDStrom™ has shown positive outcomes in a Phase 2 trial, improving symptoms such as itch, pain, and wound healing in RDEB patients, highlighting its potential as a life-changing therapy for those affected by this severe condition.
See More
INmune Bio Hosts Webinar on Alzheimer's Treatment Pathway
- Clinical Trial Progress: Following the completion of the MINDFuL Phase 2 trial, INmune Bio has received FDA feedback supporting the advancement of XPro1595 to a registrational study in Alzheimer's patients, marking a significant milestone in early Alzheimer's treatment.
- Webinar Topics: The upcoming webinar will focus on three core topics: MINDFuL trial results, registrational study design, and FDA feedback, aiming to provide participants with in-depth insights into the clinical and commercial potential of XPro™.
- Expert Participation: The webinar will feature renowned clinical experts from Australia and Canada who will share their experiences and insights from the MINDFuL trial, further enhancing the company's authority in Alzheimer's research.
- Global Partnership Strategy: INmune Bio plans to maximize XPro™'s clinical and commercial potential through global partnerships, accelerating its development for Alzheimer's patients, which reflects the company's keen insight into market demands.
See More
INmune Bio to Host CORDStrom Webinar on RDEB Treatment
- Clinical Trial Results: INmune Bio will host a webinar on February 26, 2026, to share the latest clinical trial results of CORDStrom for treating recessive dystrophic epidermolysis bullosa (RDEB), particularly its systemic disease-modifying capabilities, which is expected to attract significant attention.
- Efficacy Data Presentation: The webinar will highlight new data on CORDStrom's impact on key clinical benchmarks such as improvements in EBDASI skin scores, weight gain in pediatric patients, and reductions in clinical symptoms, showcasing its potential to enhance patients' quality of life.
- Expert Participation: The event will feature firsthand clinical observations from principal investigators of the MissionEB trial, including UK dermatology expert Dr. Anna Martinez and INmune Bio's Chief Scientific Officer Prof. Mark Lowdell, adding credibility to the discussions.
- CORDStrom Platform Overview: CORDStrom is a patent-pending cell medicine derived from human umbilical cord mesenchymal stem cells, designed to provide high-quality, consistent treatment options with broad potential indications, which may play a crucial role in treating complex inflammatory and autoimmune diseases.
See More
INmune Bio Receives FDA Support for Alzheimer’s Therapy
- FDA Meeting Minutes Confirmed: INmune Bio received FDA meeting minutes confirming regulatory alignment on its XPro1595 development plan for early Alzheimer’s disease, leading to a more than 6% rise in pre-market trading.
- Precision Medicine Strategy Endorsed: The FDA endorsed INmune Bio's precision medicine strategy, which employs an enrichment-led trial design to identify patients closely linked to soluble TNF signaling, enhancing treatment efficacy and targeting.
- Clinical Data Foundation Established: The FDA's assessment was based on the company's Phase 2 data package, which included cognitive and biomarker findings from the selected patient population, establishing a solid foundation for subsequent trials.
- Future Research Planning: The Phase 2 evaluation period will last nine months, aimed at building a clinical foundation for the upcoming Phase 3 study, further advancing the development of XPro1595.
See More
INmune Bio Publishes Overview on Future Applications of MSC Therapies
- MSC Therapy Outlook: INmune Bio recently published an overview in the journal Cytotherapy regarding mesenchymal stromal cell (MSC) therapies, highlighting their potential applications in inflammation, immunomodulation, and wound healing, showcasing the company's forward-looking research capabilities in cell therapy.
- CORDStrom™ Platform Progress: The review, led by INmune's Chief Scientist Dr. Nikita M. Patel, discusses systemic and local delivery methods for the CORDStrom™ platform, with plans to file a Biologics License Application (BLA) and Marketing Authorization Application (MAA) in 2026, laying the groundwork for future clinical applications.
- Strengthening Scientific Foundation: The article summarizes the current knowledge base and critical gaps in MSC therapies, aiming to propose experimental questions to enhance the development of the CORDStrom™ platform, indicating INmune's leadership in advancing MSC research.
- Clinical Research Potential: INmune Bio's CORDStrom™ platform utilizes human umbilical cord-derived mesenchymal stromal cells to provide high-quality, reproducible cellular medicines, which may have a significant impact on treating complex inflammatory and autoimmune diseases.
See More
INmune Bio Presents New XPro1595 Data for Alzheimer's Disease at CTAD
- Clinical Trial Progress: INmune Bio presented new neuroimaging data for XPro1595 at the CTAD conference, indicating the drug may slow neurodegenerative progression in early Alzheimer's patients, highlighting its potential in treating inflammation-driven Alzheimer's disease.
- Biomarker Validation: Utilizing PerpPD+ imaging analysis, the study observed a trend towards reduced cortical disarray in patients with high inflammatory burden receiving XPro1595, further validating its mechanism of selectively neutralizing soluble TNF (sTNF).
- Market Opportunity: The findings underscore the unmet medical need for inflammation-driven Alzheimer's disease, positioning XPro1595 as a first-in-class disease-modifying therapy that could present significant commercial opportunities for the company.
- Future Data Outlook: INmune Bio confirmed that additional MRI analyses will be released in 2026, expected to provide further insights into XPro1595's impact on brain tissue in Alzheimer's patients, enhancing its competitive position in the market.
See More
INmune Bio Successfully Completes Initial Commercial Pilot-Scale Production of CORDStrom™ at CGT Catapult
Successful Manufacturing Milestone: INmune Bio Inc. has completed its first full-scale pilot commercial manufacturing run of CORDStrom™, a mesenchymal stromal cell therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB), at the Cell and Gene Therapy Catapult in the UK, paving the way for regulatory submissions in 2026.
Promising Clinical Results: CORDStrom™ has shown positive outcomes in a Phase 2 trial, improving symptoms such as itch, pain, and wound healing in RDEB patients, highlighting its potential as a life-changing therapy for those affected by this severe condition.
See More
