FDA Clears Fate's FT839 Dual-Targeting CAR T for Autoimmune Trial
FATE has more than doubled off its 52-week low of $0.91.
Summary
The FDA cleared Fate's IND for FT839, an off-the-shelf, dual-targeting CAR T-cell therapy against CD19 and CD38. This is the company's second autoimmune candidate, joining FT819 in lupus nephritis. FT839 is engineered with 13 genetic edits and designed to work without conditioning chemotherapy, potentially broadening patient access. A Phase 1/2 basket trial across multiple autoimmune indications starts enrollment in H2 2026. The clearance validates Fate's iPSC platform for complex cell therapies and adds a new pipeline asset with a differentiated mechanism. Cash runway into 2028, per the Q1 update, supports this clinical expansion.
At the time of this announcement, FATE was trading at $3.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $341.5M. The 52-week trading range was $0.91 to $3.21. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.