CORRECTION: Fate Therapeutics' Receives FDA Clearance For Its Investigational New Drug Application For FT839; Enrollment In Phase 1/2 Trial Anticipated In H2 2026

Fate Therapeutics, Inc.

Fate Therapeutics, Inc.

FATE

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Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies broadly to patients with cancer and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for FT839, the Company’s next-generation, off-the-shelf CAR T-cell product candidate uniquely engineered to co-target CD19 and CD38. With IND clearance, the Company plans to advance FT839 into a basket clinical trial intended to evaluate the product candidate across a range of autoimmune diseases when administered in combination with standard-of-care therapy and without dependence on conditioning chemotherapy. Enrollment in the Phase 1/2 study is expected to commence in the second half of 2026.