Equillium Inc. (EQ, Financial) recently received feedback from the U.S. Food and Drug Administration (FDA) regarding its efforts to fast-track the approval of itolizumab, a treatment for acute graft-versus-host disease. The company had sought Breakthrough Therapy designation and an accelerated approval pathway based on data from the EQUATOR study, but the FDA did not grant these requests.
The agency emphasized the importance of achieving positive response outcomes by Day 29, as per their current guidelines. While itolizumab did not meet this criterion, the FDA showed openness to assessing other endpoints, including those evaluating longer-term results, if supported by independent data validating their significance.
Bruce Steel, the CEO of Equillium, expressed disappointment with the FDA's focus on short-term outcomes, noting the treatment's favorable safety profile and the potential benefit it may offer to patients with this severe condition. In response to the FDA's feedback, Equillium plans to expedite the closure of the EQUATOR study. The company also expressed gratitude to the patients, clinical sites, and partners involved in the study.
Wall Street Analysts Forecast
Based on the one-year price targets offered by 1 analysts, the average target price for Equillium Inc (EQ, Financial) is $1.00 with a high estimate of $1.00 and a low estimate of $1.00. The average target implies an upside of 108.33% from the current price of $0.48. More detailed estimate data can be found on the Equillium Inc (EQ) Forecast page.
Based on the consensus recommendation from 2 brokerage firms, Equillium Inc's (EQ, Financial) average brokerage recommendation is currently 3.0, indicating "Hold" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
