Fate Therapeutics Selected for U.S. FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program to Support Manufacturing Readiness of FT819

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).