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.
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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.
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.
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.
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.
INmune Bio (INMB) Declines 23.8% Over the Past Month, But a Trend Reversal Could Be Imminent
Stock Performance and Technical Analysis: INmune Bio, Inc. (INMB) has experienced a 23.8% decline over the past month, but its current RSI of 27.46 indicates it is oversold, suggesting a potential trend reversal may be imminent.
Analyst Sentiment and Earnings Estimates: There is strong consensus among analysts for improved earnings, with a 15.7% increase in the consensus EPS estimate over the last month, and INMB holds a Zacks Rank #2 (Buy), indicating a favorable outlook for the stock's recovery.
INmune Bio outlines CORDStrom BLA and MAA filings targeted for mid-2026 as CEO transition highlights strategic shift
Management Changes and Strategic Focus: David J. Moss has been appointed as the new CEO of INmune Bio, emphasizing a strategic shift away from developing XPro for Alzheimer's disease due to high costs, while focusing on advancing CORDStrom and INKmune towards regulatory approvals by mid-2026.
Financial Performance and Future Outlook: The company reported a net loss of approximately $24.5 million for Q2 2025, with cash reserves sufficient to fund operations into Q3 2026; management is pursuing partnerships and regulatory submissions to support its pipeline amidst a cautious financial strategy.
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.
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.
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.
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.
INmune Bio (INMB) Declines 23.8% Over the Past Month, But a Trend Reversal Could Be Imminent
Stock Performance and Technical Analysis: INmune Bio, Inc. (INMB) has experienced a 23.8% decline over the past month, but its current RSI of 27.46 indicates it is oversold, suggesting a potential trend reversal may be imminent.
Analyst Sentiment and Earnings Estimates: There is strong consensus among analysts for improved earnings, with a 15.7% increase in the consensus EPS estimate over the last month, and INMB holds a Zacks Rank #2 (Buy), indicating a favorable outlook for the stock's recovery.
INmune Bio outlines CORDStrom BLA and MAA filings targeted for mid-2026 as CEO transition highlights strategic shift
Management Changes and Strategic Focus: David J. Moss has been appointed as the new CEO of INmune Bio, emphasizing a strategic shift away from developing XPro for Alzheimer's disease due to high costs, while focusing on advancing CORDStrom and INKmune towards regulatory approvals by mid-2026.
Financial Performance and Future Outlook: The company reported a net loss of approximately $24.5 million for Q2 2025, with cash reserves sufficient to fund operations into Q3 2026; management is pursuing partnerships and regulatory submissions to support its pipeline amidst a cautious financial strategy.
