FT819 Hits 100% Month-6 Renal Response in Lupus Nephritis Cohort
FATE has more than doubled off its 52-week low of $0.95.
Summary
Fate reported updated preliminary Phase 1 data showing all active lupus nephritis patients on FT819 with bendamustine conditioning achieved renal response at Month 6, with roughly 50% mean proteinuria reduction. There were no dose-limiting toxicities and no high-grade CRS or ICANS, and the regimen is fludarabine-free. That safety profile matters for an off-the-shelf iPSC-derived CAR-T in autoimmune disease, where conditioning intensity drives whether outpatient dosing is feasible. The data support the ongoing Phase 2 RECLAIM-LN study, which the company has framed as potentially registrational and which dosed its first patient in August. This is early-stage and small-N, so the controlled Phase 2 readouts are what will determine whether the program holds up.
At the time of this announcement, FATE was trading at $2.13 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $252.8M. The 52-week trading range was $0.95 to $3.23. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Wiseek News.