$INMB·8-K

Inmune Bio, Inc. · Feb 13, 4:00 PM ET

Inmune Bio, Inc. 8-K

Research Summary

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Updated

INmune Bio Announces FDA End-of-Phase 2 Minutes and UK CORDStrom Pre‑submission

What Happened

  • INmune Bio, Inc. announced on its Form 8-K (filed Feb 13, 2026) that it issued two press releases: on Feb 10, 2026 the company formally submitted a pre‑submission package for its CORDStrom program to the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA); and on Feb 12, 2026 it received the official minutes from its End‑of‑Phase 2 (Type B) meeting with the U.S. Food and Drug Administration (FDA).

Key Details

  • Feb 10, 2026: CORDStrom pre‑submission package formally submitted to the UK MHRA.
  • Feb 12, 2026: Official minutes received from the FDA End‑of‑Phase 2 (Type B) meeting.
  • The company furnished the related press releases with the 8‑K (Exhibits 99.1 and 99.2).

Why It Matters

  • These regulatory interactions are formal steps in the clinical development and regulatory review path for CORDStrom; submitting a pre‑submission to the MHRA and receiving FDA End‑of‑Phase 2 minutes provide clarity on next regulatory and development milestones.
  • For investors, the updates signal that INmune Bio is actively engaging regulators in both the U.S. and U.K., which may impact timing of later‑stage trials or future regulatory submissions. The filings themselves do not include new clinical data or financial results.

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