Fate Therapeutics, Inc.·Healthcare

SAN DIEGO, May 21, 2026 (GLOBE NEWSWIRE) -- 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 to patients with cancer and autoimmune diseases, today announced that data from its off-the-shelf CAR T-cell programs will be featured at the American Society of Cancer Oncology Annual Meeting to be held in Chicago, IL, May 29 – June 2, 2026 and at the European Congress of Rheumatology being held in London, UK, June 3-6, 2026.

Fate Therapeutics (FATE) came out with a quarterly loss of $0.26 per share versus the Zacks Consensus Estimate of a loss of $0.29. This compares to a loss of $0.32 per share a year ago.

RECLAIM – LN, a Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis, on schedule to initiate in the 2 nd half of 2026

Single dose treatment of FT819 without conditioning chemotherapy achieves lupus low disease activity state (LLDAS) in active SLE Patients; durable B cell remodeling is exhibited by depletion of major B cell clones up to 12 months following treatment with B cell shift towards less class-switched BCR repertoire

FDA Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program supports the acceleration of manufacturing readiness for therapies with expedited clinical development timelines Current Regenerative Medicine Advanced Therapy (RMAT) designation and CDRP participation provide opportunity for expedited regulatory pathway and advancement of FT819 Phase 2 potentially registrational clinical trial in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis SAN DIEGO, May 05, 2026 (GLOBE NEWSWIRE) -- 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 diseases, today announced that the U.S. Food and Drug Administration (FDA) has selected FT819 for participation in the Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) Program for treatment of moderate to severe systemic lupus erythematosus (SLE). The FDA CDRP Program is a highly selective initiative, with no more than nine proposals accepted annually across the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).

SAN DIEGO, May 04, 2026 (GLOBE NEWSWIRE) -- 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 to patients with cancer and autoimmune diseases, today announced that data from its off-the-shelf CAR T-cell programs FT819, FT839, and FT836, will be featured at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting to be held in Boston, MA, May 11–15, 2026. Fate Therapeutics will present clinical and translational data from the systemic lupus erythematosus (SLE) arm of its ongoing Phase 1 trial evaluating FT819 in Regimen B, where FT819 is added to background maintenance therapy without the use of conditioning chemotherapy to drive B cell depletion and improve patient outcome.
Fate Therapeutics, Inc., a clinical-stage biopharmaceutical company, develops programmed cellular immunotherapies for cancer and immune disorders worldwide. Its NK- and T-cell immuno-oncology programs under development include FT516 for the treatment of acute myeloid leukemia (AML) B-cell lymphoma, and advanced solid tumor; FT596 to treat B-cell lymphoma and chronic lymphocytic leukemia; FT538 to treat AML and multiple myeloma; FT576 to treat multiple myeloma; FT819 to treat hematologic malignancies and solid tumors; FT536 to treat solid tumors; and FT500 for the treatment of advanced solid tumors. The company has a collaboration and option agreement with Ono Pharmaceutical Co. Ltd. for the development and commercialization of two off-the-shelf iPSC-derived CAR T-cell product candidates; strategic research collaboration and license agreement with Juno Therapeutics, Inc. to screen for and identify small molecule modulators that enhance the therapeutic properties of genetically-engineered T-cell immunotherapies; and a collaboration and option agreement with Janssen Biotech, Inc. Fate Therapeutics, Inc. was incorporated in 2007 and is headquartered in San Diego, California.
Healthcare
Biotechnology
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2013-10-01
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