Equillium (EQ) Announces Feedback from the FDA
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Equillium Announces Feedback from the U.S. Food and Drug Administration
April 24, 2025 9:00 AM EDTLA JOLLA, Calif.--(BUSINESS WIRE)-- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that the company has received feedback from its Type D meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway for Accelerated Approval, as well as the companys filing for Breakthrough Therapy designation for itolizumab for first-line treatment of acute graft-versus-host disease (aGVHD).
The FDA declined to grant Breakthrough Therapy designation or support... More
