INmune Bio Inc. - Common stock (INMB)

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).

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

LONDON, UK and BOCA RATON, FL, May 05, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (“INmune Bio”), a clinical-stage biotechnology company, and Anthony Nolan, a pioneering UK-based charity that set up the world's first stem cell register and is now driving forward cell therapy advancements, today announced the signing of an amended and restated Material Transfer and License Agreement. This expanded collaboration secures the long-term provision of high-quality umbilical cord tissue to power INmune Bio’s CORDStrom™ platform, the industry’s most advanced Mesenchymal Stromal Cell (MSC) technology designed to deliver consistent, scalable, and "off-the-shelf" cellular therapies which are suitable for supply in UK, EU and US, as well as other global regions.

Management to host conference call and webcast at 4:30 pm ET on that day

BOCA RATON, Fla., April 16, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage biotechnology company focused on developing therapies that harness the patient’s innate immune system, today announces new preclinical data for INB03 (XPro1595 for oncology).  The data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 in San Diego on April 17-22.

Management to host conference call and webcast at 4:30 pm ET on that day

Plenary Presentation Highlights How Aligning Inflammatory Biomarker Enrichment with Mechanism of Action Offers a Blueprint for Success in Alzheimer’s Drug Development

Webinar on February 27 at 9:30 AM ET will have key opinion leaders discuss recent and upcoming clinical development of XPro1595

Clinical investigators from the trial to share real-world experience treating RDEB patients with CORDStrom and present new data from the MissionEB clinical study

Agency Feedback Provides Regulatory Clarity on Enrichment Strategy and Confirms CDR-SB as Sole Primary Endpoint for Registrational Development

Pre-submission package is a process that facilitates early feedback from the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA), designed to streamline the final approval process and reduce time to market

Boca Raton, FL, Jan. 27, 2026 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage inflammation and immunology company, presents the following letter to investors from David Moss, CEO:

Boca Raton, FL, Dec. 05, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (“INmune” or the “Company”), a clinical-stage inflammation and immunology company, announces a recently published overview of future applications and research areas for mesenchymal stromal cell (MSC) therapies, such as INmune’s CORDStrom™ platform. The article, titled, “Fate and Function of Exogenously Administered MSCs: Current Insights and Future Directions,” was published in the peer-reviewed journal Cytotherapy. One of the lead authors of the paper was INmune Bio’s lead scientist for CORDStrom™ R&D, Dr Nikita M. Patel, M.Sci.,Ph.D.

Boca Raton, FL, Dec. 01, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage biotechnology company developing inflammation and immunology therapies targeting innate immune dysfunction, announces new neuroimaging data from its Phase 2 MINDFuL trial of XPro1595 in patients with early Alzheimer’s disease (AD) and elevated neuroinflammation. The results will be presented at the 18th Clinical Trials on Alzheimer’s Disease conference (CTAD), being held on December 1-4, 2025 in San Diego, CA.

Boca Raton, FL, Nov. 18, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage inflammation and immunology company, today announces two presentations at the upcoming 18th Clinical Trials on Alzheimer’s Disease conference (CTAD), in San Diego, CA on December 1-4, 2025.

Management to host conference call and webcast at 4:30 pm ET on that day

Boca Raton, FL, Oct. 14, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage inflammation and immunology company, today announces that David Moss, Chief Executive Officer will participate in a Dermatologic Rare Disease Panel at the Maxim Growth Summit presented by Maxim Group LLC.  The Summit is being held on October 22 – 23, 2025 at the Hard Rock Hotel in New York City.

Boca Raton, FL, Sept. 29, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage inflammation and immunology company, today announces the submission of a manuscript detailing the results of its Phase 2 MINDFuL trial. The manuscript, titled, “XPro1595, a Selective Soluble TNF Neutralizer, in Early Alzheimer’s Disease with Inflammation (ADi): Results from the Phase 2 MINDFuL Trial,” has been submitted for peer review to npj Dementia, a Nature Portfolio journal.

BOCA RATON, Fla., Sept. 15, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (“INmune” or “the Company”), a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announced the successful completion of its first full-scale pilot commercial manufacturing run of CORDStrom™, an off-the-shelf, allogeneic, umbilical cord tissue-derived mesenchymal stromal cell therapy for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB). This milestone, achieved at the Cell and Gene Therapy Catapult’s state-of-the-art Manufacturing Innovation Centre in Stevenage, United Kingdom, marks a critical step toward regulatory submissions and keeps the Company on track for filing a Marketing Authorization Application (MAA) in the UK during the first half of 2026 followed by a Biologics License Application (BLA) in the US.

BOCA RATON, FL, Aug. 04, 2025 (GLOBE NEWSWIRE) --  INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, is pleased to report that its Phase I/II trial (the “CaRe PC” trial) of INKmune™ for men with metastatic castration-resistant prostate cancer (mCRPC) has met its primary and secondary endpoints and is now closed to further enrollment.

Management to host conference call and webcast at 4:30 pm ET on that day

Boca Raton, July 29, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) announced today that a video detailing the additional findings from the Phase 2 MINDFuL trial evaluating XPro™, a novel selective soluble TNF inhibitor, will be published on the company’s YouTube Channel following the conclusion of Alzheimer’s Association International Conference (AAIC) in Toronto, Canada.