{"id":936437,"date":"2026-02-12T07:05:20","date_gmt":"2026-02-12T12:05:20","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\/"},"modified":"2026-02-12T07:05:20","modified_gmt":"2026-02-12T12:05:20","slug":"inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\/","title":{"rendered":"INmune Bio Announces FDA Alignment on Integrated Phase 2b\/3 Registration Pathway for XPro1595 in Early Alzheimer\u2019s Disease"},"content":{"rendered":"<div class=\"mw_release\">\n<p>\n        <em>Agency Feedback Provides Regulatory Clarity on Enrichment Strategy and Confirms CDR-SB as Sole Primary Endpoint for Registrational Development<\/em>\n      <\/p>\n<p>\n        <em><br \/>\n          <br \/>\n        <\/em>\n      <\/p>\n<p>\n        <b>Boca Raton, FL, Feb.  12, 2026  (GLOBE NEWSWIRE) &#8212; <\/b> INmune Bio, Inc. (NASDAQ: INMB) (\u201cINmune Bio\u201d or the \u201cCompany\u201d), a late-stage biotechnology company focused on inflammation and immunology, today announced that it received the official minutes from its End-of-Phase 2 (Type B) meeting with the U.S. Food and Drug Administration (FDA).\u00a0 The minutes confirm regulatory alignment on the Company\u2019s proposed integrated Phase 2b\/3 clinical development strategy for XPro1595 in early Alzheimer\u2019s Disease (AD).<\/p>\n<p>\u201cThe outcome of the End-of-Phase 2 interaction is an important inflection point for XPro1595,\u201d said CJ Barnum, PhD, Vice President of Neuroscience at INmune Bio. \u201cThe FDA\u2019s 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\u2019s disease.\u201d<\/p>\n<p>The FDA&#8217;s feedback was consistent with the Company&#8217;s precision medicine approach, which utilizes an enrichment-led trial design to identify patients whose inflammatory biomarker profiles are mechanistically linked to soluble TNF signaling, the biological target of XPro1595. The Agency&#8217;s review was informed by the Company&#8217;s Phase 2 clinical data package, including cognitive and biomarker analyses in the enriched population.<\/p>\n<p>\n        <b>Key Highlights of FDA Alignment:<\/b>\n      <\/p>\n<ul type=\"disc\">\n<li>\n          <b>Integrated Phase 2b\/3 Framework: <\/b>The FDA indicated no objection to the Company&#8217;s proposed integrated Phase 2b\/3 design under a single master protocol. The Phase 2b portion will enroll approximately 300 participants over a nine-month evaluation period designed to validate key efficacy and biomarker assumptions before expansion into the Phase 3 registration segment. The full program is expected to enroll approximately 1,000 participants, with the Phase 3 portion evaluating XPro1595 over 18 months.<\/li>\n<\/ul>\n<p>\n        \n      <\/p>\n<ul type=\"disc\">\n<li>\n          <b>CDR-SB as Sole Primary Endpoint:\u00a0<\/b>The FDA raised no objection to the use of Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) as the sole primary efficacy endpoint for the Phase 3 portion of the study.\u00a0 CDR-SB is the primary endpoint used in recently approved Alzheimer&#8217;s disease therapies.<\/li>\n<\/ul>\n<p>\n        \n      <\/p>\n<ul type=\"disc\">\n<li>\n          <b>Biomarker-Driven Enrichment Strategy Supported:<\/b>\u00a0The FDA raised no objection to the Company\u2019s inflammation-based enrichment strategy, which will enroll patients defined by two or more biomarkers associated with peripheral inflammation and immune-mediated disease risk (hsCRP, ESR, HbA1c, APOE4), which are mechanistically linked to soluble TNF signaling.\u00a0 This approach is designed to align patient biology with XPro1595\u2019s selective soluble TNF mechanism of action and supports a precision medicine development strategy.<\/li>\n<\/ul>\n<p>\n        \n      <\/p>\n<ul type=\"disc\">\n<li>\n          <b>Exploratory Cohort:\u00a0<\/b>At the FDA\u2019s recommendation, the trial will include an exploratory cohort (approximately 20% of enrollment) of non-enriched early Alzheimer\u2019s Disease patients to assess the broader effect of XPro1595. This cohort is not required to be independently powered, and in the absence of a treatment signal at month 9, it would not be required to continue into the Phase 3 segment.<\/li>\n<\/ul>\n<p>The Phase 2b portion of the study includes a nine-month evaluation period designed to establish the clinical evidence base for Phase 3. The Phase 2b assessment will be informed by the Early Mild Alzheimer&#8217;s Cognitive Composite (EMACC), a cognitive measure, and plasma p-tau-217, a marker of neurodegeneration. These endpoints were selected for their demonstrated sensitivity to early changes over shorter treatment periods. CDR-SB is the sole primary efficacy endpoint for Phase 3, consistent with its established role as a global functional outcome measure in registrational Alzheimer&#8217;s programs. Final powering assumptions and statistical analyses will be specified in the study protocol, which will be submitted for FDA review.<\/p>\n<p>\u00a0\u201cOur Phase 2 MINDFuL trial provided important insights into cognitive and biomarker measures in the enriched population,\u201d said Dr. Barnum. \u201cThese findings informed the statistical assumptions and powering strategy for the Phase 3 portion of the program.\u00a0\u00a0 We are encouraged that the FDA raised no objections to the use of CDR-SB as the sole primary endpoint for the Phase 3 segment of the proposed study, which is intended to support a registrational-directed program.\u201d<\/p>\n<p>\u201cOur End-of-Phase 2 interaction with the FDA reflects alignment between our proposed development strategy and the Agency\u2019s expectations for late-stage Alzheimer\u2019s programs,\u201d said David Moss, Chief Executive Officer of INmune Bio. \u201cXPro1595 represents a differentiated approach to Alzheimer\u2019s disease, based on precision patient selection and selective immune modulation, with a favorable safety profile that included zero cases of ARIA in our Phase 2 study. We appreciate and thank the FDA for its constructive engagement and look forward to advancing XPro1595 in a registration-directed program.\u201d<\/p>\n<p>INmune Bio is incorporating the FDA\u2019s feedback into the final Phase 2b\/3 protocol and anticipates submitting the protocol to the Agency for review. The Company will provide additional updates on timelines as the protocol is finalized.<\/p>\n<p>\n        <b>About XPro\u2122<\/b>\n      <\/p>\n<p>XPro\u2122 is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro\u2122 could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of INmune Bio\u2019s website.<\/p>\n<p>\n        <b>About INmune Bio Inc.<\/b>\n      <\/p>\n<p>INmune Bio Inc. is a publicly traded (NASDAQ: INMB), late-stage clinical biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has three product platforms: (1) CORDStrom\u2122, a proprietary pooled, allogeneic, human umbilical cord-derived mesenchymal Stromal\/Stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa; (2) XPro\u2122, a Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform designed to selectively neutralize soluble TNF, a key driver of inflammation and innate immune dysfunction; and (3) INKmune\u00ae, a cell-based medicine designed to prime a patient\u2019s natural killer cells to eliminate minimal residual disease in patients with cancer. To learn more, please visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=gmG9EEwIz7fxBCdkJsxjdNzgRkNUOi-KvQNG9w7HA3yAOYnDAPiZyGDQOY_3ilwg0VxQncZYM3AovY_I3ffMVguixLzPOhqGL1eLSxdgQGY=\" rel=\"nofollow\" target=\"_blank\">www.inmunebio.com<\/a>.<\/p>\n<p>\n        <b>Forward-Looking Statements<\/b>\n      <\/p>\n<p>Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including trial results, timing of key milestones, future plans or expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, including statements regarding FDA feedback or the design of future clinical trials, may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.\u00a0 FDA feedback, including statements that the Agency has no objection to aspects of a proposed trial design, does not constitute approval or an agreement that such design will be sufficient to support regulatory approval. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDstrom\u2122, XPro1595\u2122 (XPro\u2122, pegipanermin), and INKmune\u00ae\u2122 have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company\u2019s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company\u2019s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company\u2019s filings with the Securities and Exchange Commission, including the Company\u2019s Annual Report on Form 10-K, the Company\u2019s Quarterly Reports on Form 10-Q and the Company\u2019s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release.<\/p>\n<p>\n        <b>INmune Bio Contacts:<\/b>\n      <\/p>\n<p>David Moss<br \/>Chief Executive Officer<br \/>(561) 710-0512<\/p>\n<p>\n        <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=SYxjcWgqD7XWitIt4-aWTmIi64e0LmjtiEALGZcm3TFNEeFzvzG4rV5F7L5F6nlhv56in3p48DJ-9QW64W36cji3-k2o3wyTTkpbbhgscLA=\" rel=\"nofollow\" target=\"_blank\">info@inmunebio.com<\/a>\n      <\/p>\n<p>Daniel Carlson<br \/>Head of Investor Relations<br \/>(415) 509-4590<\/p>\n<p>\n        <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=daDUYQCFILkl1Sj1d4HiJ-eQHlURUADq7I1lkW9CLXUYdLyk8GZ2lXM7QuZb8IL9bFLsbhlQUjQnW_WOBdvfeRSYh_qqzHIK2t57igr6YME=\" rel=\"nofollow\" target=\"_blank\">dcarlson@inmunebio.com<\/a>\n      <\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTY1MzQ5MiM3NDIyODM5IzUwMDA2ODMyNA==\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/OTlkYWI5MDMtOTkyYy00ZDdjLWEzNjgtOWEzNjQ4MzAyYTg5LTUwMDA2ODMyNC0yMDI2LTAyLTEyLWVu\/tiny\/INmune-Bio-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Agency Feedback Provides Regulatory Clarity on Enrichment Strategy and Confirms CDR-SB as Sole Primary Endpoint for Registrational Development Boca Raton, FL, Feb. 12, 2026 (GLOBE NEWSWIRE) &#8212; INmune Bio, Inc. (NASDAQ: INMB) (\u201cINmune Bio\u201d or the \u201cCompany\u201d), a late-stage biotechnology company focused on inflammation and immunology, today announced that it received the official minutes from its End-of-Phase 2 (Type B) meeting with the U.S. Food and Drug Administration (FDA).\u00a0 The minutes confirm regulatory alignment on the Company\u2019s proposed integrated Phase 2b\/3 clinical development strategy for XPro1595 in early Alzheimer\u2019s Disease (AD). \u201cThe outcome of the End-of-Phase 2 interaction is an important inflection point for XPro1595,\u201d said CJ Barnum, PhD, Vice President of Neuroscience at INmune Bio. \u201cThe FDA\u2019s feedback on &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;INmune Bio Announces FDA Alignment on Integrated Phase 2b\/3 Registration Pathway for XPro1595 in Early Alzheimer\u2019s Disease&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-936437","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>INmune Bio Announces FDA Alignment on Integrated Phase 2b\/3 Registration Pathway for XPro1595 in Early Alzheimer\u2019s Disease - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"INmune Bio Announces FDA Alignment on Integrated Phase 2b\/3 Registration Pathway for XPro1595 in Early Alzheimer\u2019s Disease - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Agency Feedback Provides Regulatory Clarity on Enrichment Strategy and Confirms CDR-SB as Sole Primary Endpoint for Registrational Development Boca Raton, FL, Feb. 12, 2026 (GLOBE NEWSWIRE) &#8212; INmune Bio, Inc. (NASDAQ: INMB) (\u201cINmune Bio\u201d or the \u201cCompany\u201d), a late-stage biotechnology company focused on inflammation and immunology, today announced that it received the official minutes from its End-of-Phase 2 (Type B) meeting with the U.S. Food and Drug Administration (FDA).\u00a0 The minutes confirm regulatory alignment on the Company\u2019s proposed integrated Phase 2b\/3 clinical development strategy for XPro1595 in early Alzheimer\u2019s Disease (AD). \u201cThe outcome of the End-of-Phase 2 interaction is an important inflection point for XPro1595,\u201d said CJ Barnum, PhD, Vice President of Neuroscience at INmune Bio. \u201cThe FDA\u2019s feedback on &hellip; Continue reading &quot;INmune Bio Announces FDA Alignment on Integrated Phase 2b\/3 Registration Pathway for XPro1595 in Early Alzheimer\u2019s Disease&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-02-12T12:05:20+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTY1MzQ5MiM3NDIyODM5IzUwMDA2ODMyNA==\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"INmune Bio Announces FDA Alignment on Integrated Phase 2b\\\/3 Registration Pathway for XPro1595 in Early Alzheimer\u2019s Disease\",\"datePublished\":\"2026-02-12T12:05:20+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\\\/\"},\"wordCount\":1403,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTY1MzQ5MiM3NDIyODM5IzUwMDA2ODMyNA==\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\\\/\",\"name\":\"INmune Bio Announces FDA Alignment on Integrated Phase 2b\\\/3 Registration Pathway for XPro1595 in Early Alzheimer\u2019s Disease - 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(NASDAQ: INMB) (\u201cINmune Bio\u201d or the \u201cCompany\u201d), a late-stage biotechnology company focused on inflammation and immunology, today announced that it received the official minutes from its End-of-Phase 2 (Type B) meeting with the U.S. Food and Drug Administration (FDA).\u00a0 The minutes confirm regulatory alignment on the Company\u2019s proposed integrated Phase 2b\/3 clinical development strategy for XPro1595 in early Alzheimer\u2019s Disease (AD). \u201cThe outcome of the End-of-Phase 2 interaction is an important inflection point for XPro1595,\u201d said CJ Barnum, PhD, Vice President of Neuroscience at INmune Bio. \u201cThe FDA\u2019s feedback on &hellip; Continue reading \"INmune Bio Announces FDA Alignment on Integrated Phase 2b\/3 Registration Pathway for XPro1595 in Early Alzheimer\u2019s Disease\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\/","og_site_name":"Market Newsdesk","article_published_time":"2026-02-12T12:05:20+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTY1MzQ5MiM3NDIyODM5IzUwMDA2ODMyNA==","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"7 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"INmune Bio Announces FDA Alignment on Integrated Phase 2b\/3 Registration Pathway for XPro1595 in Early Alzheimer\u2019s Disease","datePublished":"2026-02-12T12:05:20+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\/"},"wordCount":1403,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTY1MzQ5MiM3NDIyODM5IzUwMDA2ODMyNA==","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/inmune-bio-announces-fda-alignment-on-integrated-phase-2b-3-registration-pathway-for-xpro1595-in-early-alzheimers-disease\/","name":"INmune Bio Announces FDA Alignment on Integrated Phase 2b\/3 Registration Pathway for XPro1595 in Early Alzheimer\u2019s Disease - 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