Equillium, Inc.

Equillium’s lead asset itolizumab did not meet the primary endpoint at Day 29 in its pivotal Phase 3 EQUATOR trial for first-line aGVHD but showed statistically significant and clinically meaningful benefits on longer-term outcomes such as complete response at Day 99 and failure-free survival. The FDA declined Breakthrough Therapy designation and Accelerated Approval based on current data but indicated willingness to consider alternative endpoints with further supporting evidence. Other pipeline assets include multi-cytokine inhibitors targeting autoimmune/inflammatory diseases. The company continues to seek strategic options for advancing or partnering its programs.