FDA declines itolizumab accelerated approval, says Equillium

US biotech Equillium’s (Nasdaq EQ) shares fell by 3% to $0.47 after the company announced that the US 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 highlighted its attention to achieving response outcomes at Day 29, per existing FDA guidance; however, the agency did indicate openness to evaluating other endpoints, including longer term outcomes, provided independent data supports the validity of such endpoints.

Leerink analyst Thomas Smith commented on the situation, reiterating a Market Perform stock rating on Equillium. Mr Smith said he considers this feedback to be disappointing, but not entirely surprising. “We continue to see significant uncertainty on the path forward for itolizumab, as well as the company’s financing overhang - both of which keep us on the sidelines,” he added.