Fate Therapeutics’ new CAR T-cell therapy fast-tracked by FDA

SAN DIEGO – Fate Therapeutics Inc. (NASDAQ:FATE), currently trading at $1.06 per share and maintaining a strong current ratio of 7.58, has announced that its off-the-shelf CAR T-cell therapy, FT819, received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the treatment of systemic lupus erythematosus (SLE), including lupus nephritis (LN). According to InvestingPro data, the company holds more cash than debt on its balance sheet, providing financial flexibility for its development programs. The RMAT designation, part of the 21st Century Cures Act, is granted to expedite the development and review of regenerative medicine therapies for serious conditions.

FT819 is currently in a Phase 1 clinical trial, which includes a fludarabine-free conditioning regimen and aims to evaluate the safety and efficacy of the therapy. Initial clinical safety and activity data from the trial contributed to the RMAT designation. The company is expanding dose levels in the ongoing trial and plans to present additional Phase 1 data at medical conferences later in 2025. With five analysts recently revising their earnings estimates upward for the upcoming period, market sentiment appears positive despite the company’s significant cash burn rate.

The RMAT designation allows for increased dialogue with the FDA and includes features similar to the Breakthrough Therapy designation, such as early discussions on surrogate or intermediate endpoints and potential priority review for the biologics license application.

Fate Therapeutics is developing FT819 as an iPSC-derived CAR T-cell therapy designed to be available on-demand, potentially reducing patient burden and expanding access to underserved areas. The company’s proprietary iPSC product platform aims to overcome limitations associated with patient- and donor-sourced cell therapies by using clonal master iPSC lines for manufacturing uniform cell products.

The clinical development of FT819 is supported by a $7.9 million grant from the California Institute of Regenerative Medicine (CIRM). The company’s iPSC platform is protected by a substantial intellectual property portfolio, including over 500 issued patents and 500 pending applications. While the stock has experienced volatility, showing a -65% return over the past six months, it has recently demonstrated strength with a 16.5% gain in the past week. Discover more insights about FATE’s potential with InvestingPro, which offers 12 additional exclusive tips and comprehensive financial analysis through its Pro Research Report.

Fate Therapeutics’ pipeline includes multiple iPSC-derived T-cell and natural killer (NK) cell product candidates, designed to deliver various therapeutic mechanisms. The company’s approach to cellular immunotherapy involves multiplexed-engineering of human iPSCs and single-cell selection to create these clonal master iPSC lines.

This announcement is based on a press release statement and does not include any recommendations or endorsements of the company’s claims. The safety and efficacy of FT819 have yet to be established, and the therapy is still undergoing clinical investigation. Based on InvestingPro’s Fair Value analysis, the stock currently appears undervalued, though investors should note that analysts anticipate a sales decline in the current year.

In other recent news, Fate Therapeutics reported fourth-quarter 2024 financial results that exceeded revenue expectations, posting $1.86 million against the analyst consensus estimate of $1.58 million. The company also announced adjusted earnings per share of -$0.44, aligning with Wall Street forecasts. Fate Therapeutics has a solid cash position, ending the quarter with $306.7 million, which is anticipated to fund operations through 2026. Jefferies analyst Michael Yee revised the company’s price target to $8.00 from $10.00, maintaining a Buy rating. This follows promising data presentations and management changes, including a new CEO. Stifel also adjusted its outlook, reducing the price target to $3.00 from $5.00 while maintaining a Hold rating. The company is progressing with its FT819 program, initiating dose expansion in systemic lupus erythematosus using a fludarabine-free conditioning regimen. Additionally, Fate Therapeutics completed a Type D meeting with the FDA, paving the way for broader clinical investigations. Investors are keenly observing the company’s advancements in its clinical programs and upcoming data releases.

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