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SAN DIEGO - Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biotech company currently valued at $191 million, reported that all three patients with severe lupus nephritis treated with its FT819 cell therapy following a fludarabine-free conditioning regimen achieved Primary Efficacy Renal Response, according to data presented at the European Alliance of Associations for Rheumatology Congress in Barcelona. The company’s stock has shown strong momentum, gaining over 17% in the past week following these positive results.
The company also reported that the first patient to reach one-year follow-up continues in drug-free remission. Additionally, an extrarenal lupus patient treated with FT819 without conditioning chemotherapy achieved Low Lupus Disease Activity State at three months, which was maintained at six months. According to InvestingPro data, while the company maintains a strong liquidity position with a current ratio of 8.81, it faces challenges with significant cash burn, a key consideration for biotech investors following clinical developments.
FT819 is an off-the-shelf, CD19-targeted CAR T-cell product candidate derived from induced pluripotent stem cells. The therapy is being evaluated in patients with moderate-to-severe systemic lupus erythematosus.
"The initial clinical profile of our FT819 off-the-shelf CAR T-cell program in moderate-to-severe SLE has shown clear therapeutic differentiation," said Bob Valamehr, President and CEO of Fate Therapeutics.
According to the company, patients treated with FT819 in the fludarabine-free conditioning regimen showed rapid B-cell depletion within the first month, with the B-cell compartment shifting toward a non-switched, naïve repertoire.
The company reported a favorable safety profile across 59 patients treated with FT819 for various conditions, with low incidence of low-grade cytokine release syndrome, no immune effector cell-associated neurotoxicity, and no graft-versus-host disease.
Fate Therapeutics plans to expand the program to include anti-neutrophilic cytoplasmic antibody-associated vasculitis, idiopathic inflammatory myositis, and systemic sclerosis in the second half of 2025. For investors seeking deeper insights into Fate Therapeutics’ financial health and growth prospects, InvestingPro offers comprehensive analysis with 14 additional ProTips and detailed metrics, including revenue forecasts and analyst recommendations.
The company stated it has approximately 450 cryopreserved drug product bags of FT819 in inventory available for patient treatment, based on the press release statement. With cash holdings exceeding its debt obligations and trading at a relatively low revenue multiple, Fate Therapeutics maintains a Fair financial health score according to InvestingPro’s comprehensive assessment framework.
In other recent news, Fate Therapeutics has reported several significant developments. The company’s off-the-shelf CAR T-cell therapy, FT819, has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration for the treatment of systemic lupus erythematosus, including lupus nephritis. This designation aims to expedite the development and review of regenerative medicine therapies for serious conditions. Additionally, Fate Therapeutics plans to present clinical data from the ongoing Phase 1 trial of FT819 at the European Congress of Rheumatology (EULAR 2025) in Barcelona, Spain. The trial evaluates the safety and efficacy of the therapy, which is currently in a fludarabine-free conditioning regimen phase. In other updates, Baird analyst Jack Allen has adjusted the price target for Fate Therapeutics stock to $4, down from $5, while maintaining a Neutral rating. The adjustment follows the company’s first-quarter financial results and pipeline updates, which aligned with market expectations. Allen noted the competitive nature of the autoimmune cell therapy market and expressed tempered expectations for investor excitement. Fate Therapeutics is also expanding its clinical program for FT819 to international sites, indicating a commitment to broadening the reach of its therapies.
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