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Fate Therapeutics Wins Regenerative Medicine Advanced Therapy Designation From FDA For FT819 To Treat Moderate To Severe Systemic Lupus Erythematosus

Author: Benzinga Newsdesk | April 14, 2025 07:05am

–   Recognizes potential of off-the-shelf CAR T-cell therapy to address significant unmet need and enables increased dialogue with FDA throughout the development process

–   RMAT review by FDA included initial clinical safety and activity data from ongoing Phase 1 study of FT819 in SLE

 

–   Additional Phase 1 clinical data of FT819 to be presented at medical conferences in 2025

Posted In: FATE


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