INmune Bio Inc. (NASDAQ:INMB) saw its stock rise 10.3% in premarket trading Thursday following an announcement that the U.S. Food and Drug Administration has granted Fast Track designation to XPro™ (pegipanermin) for use in early Alzheimer’s disease.
The Fast Track status applies to XPro™ for treatment of early Alzheimer’s disease, explicitly including mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia. Fast Track designation is intended to facilitate development and expedite regulatory review for therapies addressing serious conditions with unmet medical needs.
XPro™ is described by the company as a first-in-class selective soluble tumor necrosis factor - or sTNF - inhibitor. Soluble TNF is thought to play a central role in the neuroinflammatory processes linked to Alzheimer’s disease progression. According to the company announcement, XPro™ selectively neutralizes sTNF while leaving intact immune functions that are involved in protecting and repairing the brain.
Fast Track status affords INmune Bio opportunities for more frequent engagement with the FDA and, if the drug meets relevant criteria, potential eligibility for mechanisms such as Rolling Review and other expedited review pathways.
The company said it intends to run a Phase 2b/3 seamless adaptive trial aimed at supporting registration of XPro™ in patients with early Alzheimer’s disease who exhibit biomarkers of inflammation. The Phase 2b segment is planned to use EMACC and plasma pTau217 as decision-gating endpoints to determine adaptive advancement into the Phase 3 portion of the study.
The public-health context cited by the company includes figures from the Alzheimer’s Association 2026 Facts and Figures report: an estimated 7.4 million Americans aged 65 or older are living with Alzheimer’s dementia, and a further 15 million individuals experience mild cognitive impairment, a precursor stage that can precede dementia. Of those with an Alzheimer’s diagnosis, about 2.9 million are in the mild stage of the disease. The company noted that no approved therapy currently targets inflammatory pathways in Alzheimer’s disease.
Market reaction and outlook
Shares rallied in premarket trading on the regulatory development. The Fast Track designation does not guarantee approval but is intended to accelerate review processes where appropriate. INmune Bio’s next steps focus on advancing the planned Phase 2b/3 adaptive trial using inflammatory biomarkers to guide progression to a registrational Phase 3.