Equillium announces FDA declined Breakthrough Therapy and Accelerated Approval for itolizumab in aGVHD

Equillium, Inc.

FDA declined Breakthrough Therapy designation and Accelerated Approval for itolizumab in aGVHD based on EQUATOR study data.
FDA focused on Day 29 outcomes; itolizumab did not show improvement by Day 29 despite favorable safety and longer-term data.
Company plans to accelerate closure of EQUATOR study and evaluate options to advance or partner itolizumab.
Cash and equivalents $14.5M as of March 31, 2025; expected to fund operations into Q3 2025.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.