Investing.com -- Equillium Inc (NASDAQ: EQ ) stock fell by 3% after the company announced the U.S. Food and Drug Administration (FDA) declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway for its drug itolizumab, intended for the treatment of acute graft-versus-host disease (aGVHD).
The FDA’s decision was based on the EQUATOR study data, which did not demonstrate improvements by Day 29, a key response outcome according to existing FDA guidance. While the FDA expressed willingness to consider other endpoints, including longer-term outcomes, it emphasized the need for independent data to validate such endpoints.
Equillium’s CEO, Bruce Steel, expressed disappointment with the FDA’s focus on Day 29 outcomes, citing the drug’s favorable safety profile and the longer-term data that suggest potential benefits for patients with aGVHD, a severe orphan disease with high mortality rates. Following the FDA’s feedback, the company plans to accelerate the closure of the EQUATOR study and is evaluating options to advance or partner itolizumab for future clinical development.
Leerink analyst Thomas Smith commented on the situation, reiterating a Market Perform stock rating on Equillium. Smith remarked, "we consider this feedback to be disappointing, but not entirely surprising. We continue to see significant uncertainty on the path forward for ito, as well as the company’s financing overhang - both of which keep us on the sidelines."
The company also reported that as of March 31, 2025, its cash and cash equivalents totaled $14.5 million, which is expected to fund operations into the third quarter of 2025. However, this projection is based on assumptions and estimates that may not be accurate. Equillium remains committed to expanding its pipeline and exploring strategic options for its therapeutic candidates aimed at immuno-inflammatory diseases.
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