Fate Therapeutics Receives Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA for FT819 to Treat Moderate to Severe Systemic Lupus Erythematosus (SLE)
Fate Therapeutics, Inc. (FATE)
Last fate therapeutics, inc. earnings: 3/2 04:01 pm
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Source: GlobeNewswire
– 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 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 treatment of active moderate to severe systemic lupus erythematosus (SLE), including lupus nephritis (LN
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FATE
News
- Fate Therapeutics Presents Updated Phase 1 Clinical Data of FT819 Off-the-shelf CAR T-cell Product Candidate for Systemic Lupus Erythematosus and Preclinical Advances in Next-Generation Off-the-Shelf CAR T-cell ProgramsGlobeNewswire
- Fate Therapeutics to Present at Piper Sandler 37th Annual Healthcare Conference [Yahoo! Finance]Yahoo! Finance
- Fate Therapeutics to Present at Piper Sandler 37th Annual Healthcare ConferenceGlobeNewswire
- Fate Therapeutics Reports Third Quarter 2025 Financial Results and Business UpdatesGlobeNewswire
- Fate Therapeutics Reports New Employee Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswire
FATE
Earnings
- 11/13/25 - Beat
FATE
Sec Filings
- 11/13/25 - Form 10-Q
- 11/13/25 - Form 8-K
- 10/27/25 - Form 8-K
- FATE's page on the SEC website