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Fate Therapeutics FATE recently announced that the FDA has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational pipeline candidate FT819 for the treatment of active moderate to severe systemic lupus erythematosus (SLE), including lupus nephritis.
The RMAT designation provides the candidate with increased opportunities to meet FDA officials, as well as arrange early meetings to discuss potential surrogate or intermediate endpoints. It opens up early interactions between the FDA and sponsors to facilitate accelerated approval and potential priority review of a product’s biologics license application.
FT819 is an off-the-shelf, iPSC-derived CAR T-cell product candidate comprised of CD8αβ+ T cells with a memory phenotype and high CXCR4 expression to promote tissue trafficking.
The latest RMAT designation by the FDA underlines the potential of FT819 to address an area of significant unmet medical needs.
FATE's Price Performance
Year to date, shares of Fate Therapeutics have plunged 44% compared with the industry’s 9% decline.
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FATE's Ongoing Development Activities With FT819
FT819 is currently in early-stage development for the treatment of SLE. The company has initiated dose expansion in up to 10 patients at 360 million cells, based on clinical data from the first three patients treated with FT819 in the ongoing phase I study.
The dose expansion stage will evaluate the safety and efficacy of a fludarabine (flu)-free conditioning regimen, consisting of either bendamustine or cyclophosphamide alone, followed by a single dose of FT819.
Fate Therapeutics is also assessing the safety, pharmacokinetics, and anti-B cell activity of FT819 at 900 million cells in dose escalation. It presented data from the first three patients at the American Society of Hematology Annual Meeting. As of the data cutoff date of Dec. 4, 2024, FATE did not observe dose-limiting toxicities or any event of any grade of cytokine release syndrome, immune effector-cell associated neurotoxicity syndrome or graft-versus-host disease.
Additional data from the same is expected to be presented at a medical conference later in 2025.
Fate Therapeutics reached an agreement with the FDA to allow for the clinical investigation of additional B cell-mediated autoimmune diseases under the current phase I clinical study of FT819 in December 2024.
FATE's Zacks Rank & Stocks to Consider
Fate Therapeutics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Jazz Pharmaceuticals, Inc. JAZZ, Krystal Biotech, Inc. KRYS and ADMA Biologics, Inc. ADMA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.