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LA JOLLA, Calif. - Equillium, Inc. (NASDAQ:EQ), a biotechnology company with a market capitalization of $17.2 million focused on developing treatments for autoimmune and inflammatory disorders, has announced the FDA’s decision not to grant Breakthrough Therapy designation or support an Accelerated Approval pathway for itolizumab as a first-line treatment for acute graft-versus-host disease (aGVHD). The company’s stock has declined over 73% in the past year, according to InvestingPro data. The FDA’s feedback from the Type D meeting emphasized the importance of day 29 response outcomes, as per existing guidance, but also showed willingness to consider other endpoints supported by independent data.
Bruce Steel, CEO of Equillium, expressed disappointment with the FDA’s focus on day 29 outcomes, noting that despite the lack of improvement by this time point, the longer-term data and safety profile of itolizumab were promising. In light of the FDA’s response, Equillium plans to expedite the closure of the EQUATOR study.
Equillium remains committed to evaluating strategic options for the future clinical development of itolizumab, which may be required for approval. The company also intends to explore opportunities with its other immuno-inflammatory disease candidates.
Itolizumab is a first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM signaling pathway, which is central to the activity and trafficking of T cells involved in a number of immuno-inflammatory diseases.
As of March 31, 2025, Equillium reported cash and cash equivalents totaling $14.5 million, expected to fund operations into the third quarter of 2025. InvestingPro analysis shows the company holds more cash than debt on its balance sheet, with a current ratio of 3.93x, though it’s quickly burning through available funds. These projections are based on assumptions that may prove inaccurate. Subscribers to InvestingPro can access 10+ additional financial health indicators for EQ.
This news is based on a press release statement and includes forward-looking statements subject to risks and uncertainties. With an overall Financial Health score of 2.59 (rated as "GOOD" by InvestingPro), Equillium’s future plans and ability to raise additional capital or enter into strategic transactions are not guaranteed and may change based on various factors. Analysts do not anticipate profitability this year, with EPS forecast at -$0.95 for FY2025.
In other recent news, Equillium Inc has reported mixed results from its Phase 3 EQUATOR study of itolizumab, a drug candidate for acute graft-versus-host disease (aGVHD). The study did not meet its primary endpoint of complete response at Day 29, nor did it achieve key secondary endpoints, creating skepticism about the drug’s regulatory path. However, the treatment showed statistically significant benefits in longer-term outcomes, such as a median duration of complete response of 336 days compared to 72 days for the placebo group, and a median failure-free survival of 154 days versus 70 days. Despite the initial setback, Equillium’s CEO, Bruce Steel, remains optimistic about the drug’s potential and has filed for Breakthrough Therapy designation. The company is seeking Accelerated Approval and expects feedback from the FDA in May 2025. Analyst Thomas Smith from Leerink has downgraded Equillium’s stock rating from Outperform to Market Perform, citing uncertainty over the drug’s future. The study involved 158 patients and also highlighted itolizumab’s favorable safety profile, with no increased risk of infections or sepsis. As the study continues, Equillium is closely monitoring regulatory discussions and potential future approvals.
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