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Fate Therapeutics develops induced pluripotent stem cell (iPSC)-derived cellular immunotherapies for cancer and autoimmune diseases. News about FATE centers on its off-the-shelf CAR T-cell and NK-cell product candidates, including FT819, FT836 and FT839, and on clinical or preclinical data presented at medical and cell-therapy meetings.
Recurring updates cover FT819 in systemic lupus erythematosus and other autoimmune diseases, next-generation CAR T programs for hematological malignancies and solid tumors, manufacturing and FDA CMC interactions, Regenerative Medicine Advanced Therapy designation, investor-conference participation, financial results, and Nasdaq employee inducement equity awards.
Fate Therapeutics (FATE) will participate in a fireside chat at the 2026 Annual Cantor Global Healthcare Conference on September 9, 2026, in New York, NY.
Management will discuss FT819, its off-the-shelf CAR T-cell candidate for autoimmune diseases, the Phase 2 RECLAIM-LN lupus nephritis trial, and FT819’s safety design, and will host one-on-one investor meetings. The session will be webcast with a 30-day replay on the company’s website.
Fate Therapeutics (NASDAQ:FATE) has initiated RECLAIM-LN (NCT07570862), a Phase 2 potentially registrational clinical trial of its off-the-shelf CAR T-cell therapy FT819 in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis. The first patient was dosed in an outpatient setting and discharged the same day, and multiple patients are currently being screened at several activated sites.
The study is expected to enroll about 53 patients with Class III or IV lupus nephritis and aims to complete enrollment within 15–18 months, by the first half of 2028. Patients will receive a single 900 million-cell dose of FT819 after less-intensive conditioning with bendamustine. The primary endpoint is complete renal response at Week 26. According to Fate Therapeutics, the trial advances FT819 toward a potential accelerated regulatory pathway supported by RMAT designation and participation in the FDA CMC Development and Readiness Pilot program.
Fate Therapeutics (NASDAQ:FATE) reported second quarter 2026 results and major clinical milestones, including dosing the first lupus nephritis patient in RECLAIM-LN, a Phase 2 potentially registrational trial of off-the-shelf CAR T-cell therapy FT819, with outpatient, same-day discharge and on-demand pivotal drug product supply.
The FDA cleared the IND for FT839, enabling a Phase 1/2 basket trial in autoimmune disease, and preliminary data for FT819 in SLE and systemic sclerosis showed favorable safety and activity signals. FT836 demonstrated early anti-tumor activity in KRAS wild-type metastatic colorectal cancer. Cash, cash equivalents, and investments were $153.8 million, down $21 million sequentially, with operating expenses of $33.2 million and a net loss of $30.2 million. According to the company, its cash runway extends into 2028.
Fate Therapeutics (NASDAQ:FATE) reported that on August 1, 2026, it granted equity inducement awards to newly hired non-executive employees under its Amended and Restated Inducement Equity Plan pursuant to Nasdaq Listing Rule 5635(c)(4).
The awards include non-qualified stock options to purchase 37,300 shares of common stock at an exercise price of $2.45 per share, equal to the July 31, 2026 NASDAQ closing price, to one new employee. In addition, the company granted 45,300 RSUs covering common stock to two new non-executive employees. The options vest over four years, with 25% vesting after one year and the remaining 75% vesting in approximately equal monthly installments over the next 36 months, subject to continued employment. The RSUs vest over four years in 25% annual installments on each anniversary of the grant date, also subject to continued employment.
Fate Therapeutics (NASDAQ:FATE) received FDA clearance for its IND application for FT839, an off-the-shelf, dual-CAR T-cell candidate co-targeting CD19 and CD38 for autoimmune disease and hematologic cancers.
A Phase 1/2 basket trial in multiple autoimmune indications is expected to begin enrolling in the second half of 2026.
Fate Therapeutics (NASDAQ:FATE) will present preliminary clinical data for its off-the-shelf CAR T-cell candidate FT819 in systemic sclerosis (SSc) at the ISSCR 2026 Annual Meeting in Montréal, July 8-11, 2026.
The Phase 1 basket trial SSc arm includes treatment-refractory patients, some with up to 15 years of disease. Early data from four patients show rCRISS ≥25 and meaningful mean mRSS improvement at 3 months, with no CRS, ICANS, GvHD, hypogammaglobulinemia, or deaths reported.
Fate Therapeutics (NASDAQ:FATE) announced management participation in several third quarter 2026 investor conferences focused on healthcare and therapeutics.
Events include forums hosted by Leerink Partners, Wells Fargo, Cantor Fitzgerald, and H.C. Wainwright, with potential presentations or fireside chats and webcasts available through the company’s investor relations website.
Fate Therapeutics (NASDAQ:FATE) appointed industry veteran Laura Hamill to its Board of Directors as the company advances its iPSC-derived cell therapy pipeline toward commercialization.
Hamill brings over 30 years of commercial leadership, including roles overseeing about $22 billion in annual revenue and organizations of up to 2,500 employees.
Fate Therapeutics (NASDAQ:FATE) presented new data on its off-the-shelf CAR T-cell candidates FT819 and FT839 at EULAR 2026.
FT819 has treated 21 refractory SLE patients, showing favorable tolerability, deep B-cell depletion, improved disease activity scores, and reduced glucocorticoid use. Preclinical FT839 data showed selective elimination of activated immune cells in rheumatoid arthritis samples without conditioning chemotherapy.
Fate Therapeutics (NASDAQ:FATE) granted new employee equity awards under Nasdaq Listing Rule 5635(c)(4).
On June 1, 2026, two newly hired non-executive employees received RSUs covering 67,300 common shares under the company’s Amended and Restated Inducement Equity Plan, vesting over four years in 25% annual installments.