Penny Stock Equillium Falls After Itolizumab Treatment Fails To Show Improvement In Response Rates In Graft Versus Host Disease Patients

Core Insights - Equillium, Inc. released topline data from the Phase 3 EQUATOR study evaluating itolizumab for acute graft-versus-host disease (aGVHD), showing no significant difference in complete response (CR) or overall response rate (ORR) at Day 29 compared to placebo [1] - The study indicated statistically significant and clinically meaningful benefits in longer-term outcomes, including complete response at Day 99 and duration of complete response [2] - Itolizumab demonstrated a favorable safety profile, not increasing the risk of infections or sepsis, which are major causes of mortality in aGVHD [3] Regulatory and Future Plans - The company has filed for Breakthrough Therapy designation and has a meeting scheduled with the FDA to discuss potential Accelerated Approval for itolizumab, given the high one-year mortality rate of over 40% in aGVHD [4] - Feedback from the FDA is expected in May, with plans to submit a biologics license application in the first half of 2026 if the feedback is positive [4] Secondary Endpoint Results - Statistical significance was achieved in several secondary endpoints, including: - Duration of complete response favoring itolizumab with a median of 336 days versus 72 days, p-value 0.017 [7] - Failure-free survival favoring itolizumab with a median of 154 days versus 70 days, p-value 0.043 [7] - Complete response at Day 99 favoring itolizumab with 35 (44.9%) patients versus 22 (28.6%) patients, p-value 0.035 [7] - Positive trend in overall survival with mortality rates of 19 (24.4%) for itolizumab versus 25 (32.5%) for placebo [7] Market Reaction - Following the study results, Equillium's stock price fell by 33.3%, trading at $0.51 [6]