INMB News & Events

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."

INmune Bio has formally submitted its pre-submission package for CORDStrom with the United Kingdom's Medicines and Healthcare Products Regulatory Agency. This early engagement step is designed to solicit targeted scientific, regulatory, and procedural feedback, streamlining the full Marketing Authorization Application process and potentially shortening time to market for what could become the first systemic therapy for this devastating "butterfly skin" disease. INmune Bio has completed three commercial pilot-scale manufacturing runs at the state-of-the-art CGT Catapult facility, each demonstrating consistent product characteristics that met predefined release criteria. These manufacturing results confirm readiness for commercial supply. The Company anticipates filing a full Marketing Authorization Application with MHRA following receipt of pre-submission feedback, currently targeted for mid-summer 2026, with subsequent EU and U.S. regulatory submissions to follow in Q4, 2026, subject to regulatory alignment and manufacturing readiness.