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The study remains ongoing, with all patients having completed dosing and some in the follow-up period. Equillium is leveraging its understanding of immunobiology to develop novel therapeutics and has several assets targeting immuno-inflammatory pathways in its pipeline. With an overall Financial Health Score rated as "GREAT" by InvestingPro, the company maintains a strong balance sheet despite its development-stage status. Analysts have set a consensus target price significantly above current levels, though they don’t expect profitability this year. With an overall Financial Health Score rated as "GREAT" by InvestingPro, the company maintains a strong balance sheet despite its development-stage status. Analysts have set a consensus target price significantly above current levels, though they don’t expect profitability this year. The study did not show a significant difference in complete response or overall response rates at Day 29 when compared with placebo. However, it demonstrated statistically significant benefits in several secondary endpoints over the long term, including better complete response at Day 99, longer duration of complete response, and improved failure-free survival. While the company maintains a healthy current ratio of 3.04 and holds more cash than debt, InvestingPro data indicates a rapid cash burn rate that investors should monitor. Get access to 8 more exclusive ProTips and detailed financial metrics with an InvestingPro subscription.
Despite the lack of improvement in early response rates, the company reported that itolizumab showed a favorable safety profile and did not increase the risk of infections or sepsis, which are common complications of aGVHD. Bruce Steel, CEO of Equillium, expressed optimism about the longer-term outcomes and stated that the company has filed for Breakthrough Therapy designation and requested a meeting with the FDA to discuss the possibility of Accelerated Approval for itolizumab. Feedback from the FDA is expected in May 2025.
Dr. John Koreth from the Dana-Farber Cancer Institute highlighted the absence of approved first-line therapies for aGVHD and the significance of itolizumab’s efficacy in longer-term outcomes.
The EQUATOR study enrolled 158 patients with aGVHD and assessed the efficacy and safety of itolizumab as a first-line therapy. The primary endpoint was the complete response rate at Day 29, with key secondary endpoints including overall response rate at Day 29 and durable complete response through Day 99.
Statistically significant results favoring itolizumab included a median duration of complete response of 336 days versus 72 days for the placebo group, and a median failure-free survival of 154 days compared to 70 days. Additionally, 44.9% of patients treated with itolizumab achieved a complete response at Day 99, compared to 28.6% receiving placebo.
The study remains ongoing, with all patients having completed dosing and some in the follow-up period. Equillium is leveraging its understanding of immunobiology to develop novel therapeutics and has several assets targeting immuno-inflammatory pathways in its pipeline.
The information in this article is based on a press release statement from Equillium, Inc.
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