All three patients treated with FT819 following fludarabine-free conditioning regimen for severe lupus nephritis achieve Primary Efficacy Renal Response (PERR); first patient to reach 1-year follow-up continues in drug-free Definition of Remission in SLE (DORIS) First extrarenal SLE patient on maintenance therapy treated with FT819 in the absence of conditioning achieves Low Lupus Disease Activity State (LLDAS) at 3-month follow-up and maintained at 6 months Cumulative clinical experience in nearly 60 patie ...

Core Insights - Fate Therapeutics is presenting clinical data from its Phase 1 study of FT819, an off-the-shelf CAR T-cell therapy for moderate-to-severe systemic lupus erythematosus (SLE) at the EULAR 2025 conference [1][2] - The study evaluates the safety and efficacy of FT819 with a fludarabine-free conditioning regimen, aiming to enhance patient access and therapeutic outcomes [2][4] Company Overview - Fate Therapeutics is a clinical-stage biopharmaceutical company focused on developing induced pluripotent stem cell (iPSC)-derived cellular immunotherapies [5][6] - The company has established a leadership position in creating multiplexed-engineered master iPSC lines and manufacturing off-the-shelf iPSC-derived cell products [6] Product Platform - The iPSC product platform allows for unlimited self-renewal and differentiation into all cell types, enabling the creation of well-defined and uniform engineered cell products [4][6] - The platform is supported by over 500 issued patents and 500 pending patent applications, highlighting its innovative approach and potential for broad patient application [4]

Fate Therapeutics (FATE) reported a loss of 32 cents per share for the first quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of 39 cents. The company had reported a loss of 47 cents per share in the year-ago period.The company earned collaboration revenues of $1.6 million, which surpassed the Zacks Consensus Estimate of $1 million. Revenues declined 15.8% on a year-over-year basis. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)Revenues in the first quarter we ...

Additional Phase 1 Data for FT819 Off-the-Shelf CAR T-cell Product Candidate in Moderate-to-Severe Systemic Lupus Erythematosus to be Featured in Oral Presentation at EULAR 2025 Congress in June Regenerative Medicine Advanced Therapy Designation Granted by the FDA for FT819 in Moderate-to-Severe Systemic Lupus Erythematosus Expanding FT819 Phase 1 Study to Include Treatment of Multiple Additional B Cell-mediated Autoimmune Diseases and Ex-US Territories $273 Million in Cash, Cash Equivalents, and Investmen ...

SAN DIEGO, April 14, 2025 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical- stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)- derived off-the-shelf cellular immunotherapies to patients, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to FT819, an investigational, off-the-shelf, iPSC-derived CAR T-cell therapy in Phase 1 clinical development for the t ...