Fate Doses First Lupus Nephritis Patient in Pivotal CAR T Trial
FATE has more than doubled off its 52-week low of $0.923 on light trading volume (0.3× avg).
Summary
Fate Therapeutics dosed the first patient in RECLAIM-LN, a Phase 2 potentially registrational trial of FT819 in lupus nephritis. The patient was treated outpatient with same-day discharge, a key differentiator for off-the-shelf CAR T. Preliminary SSc data at ISSCR showed rCRISS25 or greater responses in all four treated patients with no CRS, ICANS, GvHD, or hypogammaglobulinemia. The company also appointed Laura Hamill to the board and reported a $21 million quarterly cash decrease with runway into 2028. This follows the July FDA clearance of FT839's IND, now advancing into a Phase 1/2 basket trial in autoimmune disease. The first-patient milestone in a registrational trial is a major de-risking event for the pipeline.
At the time of this announcement, FATE was trading at $2.77 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $317M. The 52-week trading range was $0.92 to $3.23. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.