INmune Bio Announces FDA Alignment on Integrated Phase 2b/3 Registration Pathway for XPro1595 in Early Alzheimer’s Disease
INmune Bio Inc. - Common stock (INMB)
Company Research
Source: GlobeNewswire
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) -- INmune Bio, Inc. (NASDAQ: INMB) (“INmune Bio” or the “Company”), 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). The minutes confirm regulatory alignment on the Company’s proposed integrated Phase 2b/3 clinical development strategy for XPro1595 in early Alzheimer’s Disease (AD). “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 re
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- INmune Bio submits pre-submission package for CORDStrom with MHRA [Yahoo! Finance]Yahoo! Finance
- INmune Bio Advances CORDStrom™ Towards UK Marketing Authorization in RDEBGlobeNewswire
- INmune Bio Inc Issues Shareholder Letter Reviewing 2025 Milestones and Outlining 2026 Strategic InitiativesGlobeNewswire
- INmune Bio (NASDAQ:INMB) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=INMB&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen</a>MarketBeat
- Peer Reviewed Study Highlights Therapeutic Potential Around Application of Stromal Cell Therapies Such as INmune Bio’s CORDStrom™ PlatformGlobeNewswire
INMB
Earnings
- 10/30/25 - Beat
INMB
Sec Filings
- 2/13/26 - Form 8-K
- 1/27/26 - Form 8-K
- 12/23/25 - Form 8-K
- INMB's page on the SEC website