Inmune Bio, Inc. 8-K

What Happened
Inmune Bio, Inc. (INMB) announced on May 14, 2026 via Form 8-K (Exhibit 99.1) that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to XPro™ (pegipanermin), the company’s first‑in‑class selective soluble TNF inhibitor, for the treatment of early Alzheimer’s disease.

Key Details

• FDA granted Fast Track designation to XPro (pegipanermin) for early Alzheimer’s disease (announcement dated May 14, 2026).
• XPro is described by the company as a first‑in‑class selective soluble TNF inhibitor.
• The company issued a press release about the designation, which is attached to the 8-K as Exhibit 99.1.

Why It Matters
Fast Track designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. For investors, this status can mean more frequent interaction with the FDA and potential eligibility for rolling review or priority review steps—factors that can accelerate regulatory timelines—though it does not guarantee approval or a specific outcome. The 8-K disclosure signals a regulatory milestone for Inmune Bio’s Alzheimer’s program and is material information for shareholders monitoring the company’s clinical and development progress.