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BofA Securities lowered its price target on Fate Therapeutics (NASDAQ:FATE) stock to $2.20 from $2.50 on Tuesday, while maintaining a Neutral rating following the company’s presentation of updated clinical data for its FT819 therapy in lupus patients. The stock, which has shown significant volatility with a beta of 2.23, has recently demonstrated strong momentum with a 17.6% gain over the past week. According to InvestingPro data, five analysts have revised their earnings estimates upward for the upcoming period.
The updated data presented at EULAR 2025 included longer follow-up for three active lupus nephritis patients from the first dose cohort who received 360 million cells with flu-free conditioning. All three patients achieved Primary Efficacy Renal Response with at least a 10-point reduction in SLEDAI2K from baseline, according to BofA.
BofA noted that one previously reported patient who achieved DORIS remains in clinical remission at the 12-month follow-up mark. Fate also reported consistent response kinetics at one month for an extrarenal lupus patient dosed with 900 million cells, along with initial data for a patient dosed without conditioning.
The company plans to meet with the FDA in August, under its RMAT designation, to discuss potential registrational pathways. Management has previously indicated the potential to move directly into registrational studies based on these results.
Despite the promising efficacy data, BofA cited the small number of patients treated and competitive positioning concerns as factors in maintaining its Neutral stance, noting "there are a number of other cell-therapy companies exploring autoimmune" treatments. With analyst targets ranging from $2 to $12, and the stock trading near its InvestingPro Fair Value, investors seeking deeper insights can access comprehensive analysis and 13 additional ProTips through InvestingPro’s detailed research reports.
In other recent news, Fate Therapeutics has reported promising results from its FT819 cell therapy in patients with severe lupus nephritis, with all three patients achieving primary efficacy renal response. Additionally, the company’s first patient to reach a one-year follow-up remains in drug-free remission. Fate Therapeutics also received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for FT819, aimed at treating systemic lupus erythematosus. This designation is intended to expedite the development and review of regenerative medicine therapies for serious conditions. Analyst firm Baird adjusted its price target for Fate Therapeutics to $4.00 while maintaining a neutral rating, following the company’s first-quarter financial results and pipeline updates. The company’s FT819 therapy, which is in a Phase 1 clinical trial, will be highlighted at the European Congress of Rheumatology (EULAR 2025) in Barcelona. Fate Therapeutics plans to expand its clinical program to international sites, focusing on autoimmune diseases. The company’s iPSC-derived CAR T-cell therapy aims to provide an on-demand treatment option, potentially reducing patient burden and expanding access to underserved areas.
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