Executive Summary
Key Events by Therapeutic Class
Directly TNF-α-Targeted Therapies
- XPro1595 (INmune Bio): FDA End-of-Phase 2 meeting confirmed regulatory alignment on an integrated Phase 2b/3 registration pathway in early Alzheimer's disease, with CDR-SB as the sole primary endpoint, inflammation-based biomarker enrichment accepted, and approximately 1,000-participant program design cleared with no objection.[1]
- NAV-240 (Navigator Medicines): FDA IND clearance received for a Phase 2a trial of the OX40L/TNF-α bispecific antibody in moderate-to-severe hidradenitis suppurativa, with dosing initiated Q1 2026.[11]
- NAV-242 (Navigator Medicines): Australian HREC approval received for the Phase 1 first-in-human program of
