Positive updated FT819 Phase 1 SLE data presented at CCR-East conference drives 21% surge.
The presentation (an encore of data with December 2025 cutoff) of results from the ongoing Phase 1 trial highlighted clinically meaningful, sustained improvements in the first 10 evaluable SLE patients (including several with lupus nephritis) treated with a single dose plus less-intensive, fludarabine-free conditioning. SLEDAI-2K scores fell substantially (mean reductions of ~50-78% at months 3-6, with drops up to 13 points at M6), Physician Global Assessment improved markedly (~1.75 points), proteinuria decreased significantly (with complete renal responses achieved), and FACIT-Fatigue scores rose ~23-24 points. Durable B-cell depletion, naïve cell reconstitution, and a clean safety profile (no Grade >2 CRS, ICANS, or GVHD) were also reported. This reinforces advancement toward a 2026 registrational trial in the high-interest autoimmune CAR-T space, sparking trader enthusiasm and well-above-average volume on May 1.
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