FDA grants RMAT designation to Autolus drug for lupus treatment

Autolus Therapeutics (NASDAQ: AUTL) announced that the U.S. Food and Drug Administration 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, established under the 21st Century Cures Act, is intended to accelerate the development and regulatory review of regenerative medicine therapies, including cell therapies, for serious or life-threatening diseases.

The designation was based on Phase 1b data from the CARLYSLE trial. Autolus Chief Development Officer Dr. Matthias Will said the designation "provides an important framework to facilitate efficient development within the LUMINA trial."

LUMINA, the company's pivotal Phase 2 study of obe-cel in patients with refractory LN, is currently enrolling patients across five countries. Autolus expects to report data from that trial in 2028.

An updated data readout from the Phase 1 CARLYSLE trial has been submitted for presentation at the American College of Rheumatology Annual Meeting, scheduled for the fourth quarter of 2026.

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