$INMB·8-K

Inmune Bio, Inc. · Jun 23, 4:05 PM ET

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Inmune Bio, Inc. 8-K

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Inmune Bio Announces MHRA Pre-MAA Meeting Minutes for CORDStrom

What Happened

  • On June 23, 2026, Inmune Bio, Inc. announced it has received official, accepted meeting minutes from a face-to-face pre-Marketing Authorization Application (pre-MAA) Scientific Advice meeting with the UK Medicines & Healthcare products Regulatory Agency (MHRA) regarding CORDStrom™ (Ebstrocel™) for Recessive Dystrophic Epidermolysis Bullosa (RDEB).
  • The company filed a press release about this development as Exhibit 99.1 to its Current Report on Form 8-K.

Key Details

  • Date of announcement: June 23, 2026.
  • Product discussed: CORDStrom™ (Ebstrocel™) for RDEB.
  • Regulator: UK MHRA; meeting type: face-to-face pre-MAA Scientific Advice.
  • Filing: Press release attached as Exhibit 99.1 to Form 8-K.

Why It Matters

  • Receiving official, accepted meeting minutes documents the outcome of a formal regulatory discussion and preserves the MHRA’s feedback on the company’s planned pathway toward a Marketing Authorization Application.
  • This is a procedural regulatory milestone (clarifying next steps and feedback), not an approval or submission; the 8-K does not report new clinical data, a filing date for a marketing application, or any financial figures. Investors should view this as an update on regulatory engagement and watch for further regulatory communications, MAA submission details, or clinical updates.

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