FDA grants RMAT designation to Autolus drug for lupus treatment
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Autolus Therapeutics Announces FDA RMAT Designation Granted to Obe-cel for the Treatment of Systemic Lupus Erythematosus and Lupus Nephritis
September 9, 2026 7:00 AM EDTEnrollment in LUMINA, the pivotal Phase 2 study of obe-cel in refractory lupus nephritis, is ongoing
LONDON and GAITHERSBURG, Md., Sept. 09, 2026 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, today announced that the U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to obecabtagene autoleucel (obe-cel) for the treatment of systemic lupus erythematosus (SLE) and lupus nephritis (LN).
RMAT designation is a program created under the 21st Century... More
