INmune Bio submits pre-submission package for CORDStrom with MHRA

5 days ago 4

TipRanks

Wed, February 11, 2026 astatine 7:12 AM CST 1 min read

INmune Bio (INMB) has formally submitted its pre-submission bundle for CORDStrom with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency. This aboriginal engagement measurement is designed to solicit targeted scientific, regulatory, and procedural feedback, streamlining the afloat Marketing Authorization Application process and perchance shortening clip to marketplace for what could go the archetypal systemic therapy for this devastating “butterfly skin” disease. INmune Bio has completed 3 commercialized pilot-scale manufacturing runs astatine the state-of-the-art CGT Catapult facility, each demonstrating accordant merchandise characteristics that met predefined merchandise criteria. These manufacturing results corroborate readiness for commercialized supply. The Company anticipates filing a afloat Marketing Authorization Application with MHRA pursuing receipt of pre-submission feedback, presently targeted for mid-summer 2026, with consequent EU and U.S. regulatory submissions to travel successful Q4, 2026, taxable to regulatory alignment and manufacturing readiness.

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