Equillium Inc. (EQ) shares gained 4.61% to $5.90 in premarket trading today. Equillium stock gained 1.81% to finish the last trading session at $5.64. Trading volume for the EQ stock was 0.18 million shares, which is higher than the 0.14 million daily average volume published over the past 50 days.

In the last five days, EQ stock price has risen -1.91%, but in the last month, it has dropped -19.20%. This year, the price of EQ stock has gained 76.80 percent so far after losing -14.29 percent over the last three months. EQ’s stock rose after it announced plans to initiate a pivotal study.

EQ’s study was about what?

Biotechnology company Equillium is developing novel products for severe autoimmune and inflammatory disorders, which have high demands for treatment. It leverages its deep understanding of immunobiology to identify and develop products. In addition to the planned pivotal study in acute graft-versus-host disease (aGVHD), EQ is also testing itolizumab in lupus/lupus nephritis and asthma.

The US Food and Drug Administration (FDA) and Equillium have completed an End-of-Phase 1 meeting for itolizumab for the treatment of acute graft-versus-host disease (aGVHD), as announced by the company in a press release yesterday.

• EQ and the FDA confirmed progress on Phase 3 pivotal study of itolizumab in aGVHD in preparation for the Biologics License Application (BLA) submission.
• EQ plans to begin its Phase 3 study in the fourth quarter of 2021.
• Due to the positive outcome of its FDA meeting, EQ will immediately begin a pivotal clinical trial, taking it one step closer to obtaining FDA approval for the first-line treatment of aGVHD.
• Current standard of care, high-dose corticosteroids, falls significantly short of the needs of this severely ill patient population.
• Clinical responses from Equillium’s EQUATE Phase 1b were rapid and durable, and a rapid abatement in systemic corticosteroid use was shown to be vital for positive long-term outcomes.
• EQ has received FDA fast track and orphan drug designations for itolizumab, and with the FDA’s feedback, the company is immediately moving to late-stage development and will focus on collecting data necessary for submission of a BLA.

How will EQ proceed with the study?

Equillium (EQ) received FDA guidance on how to design the pivotal study at this meeting. Equillium also received guidance from the FDA on chemistry, manufacturing, and controls (CMC), nonclinical, and regulatory issues to support its proposed study and BLA submission of itolizumab for the first line treatment of aGVHD in combination with corticosteroids. As a result of FDA feedback and guidance, Equillium (EQ) is finalizing the details of its Phase 3 protocol.