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) presented preliminary FT819 Phase 1 lupus nephritis data showing renal responses in both patients evaluable after bendamustine conditioning. At the August 18, 2026 cutoff, these patients achieved complete or primary efficacy renal responses at Month 6, with an approximately 50% mean reduction in urine protein-to-creatinine ratio, a measure of kidney damage. Immunosuppressants were discontinued; hydroxychloroquine and low-dose prednisone were permitted. One patient's complete response persisted through Month 24.
Across 29 autoimmune patients, no dose-limiting toxicity or deaths occurred. Low-grade cytokine release syndrome occurred in five patients; Grade ≥3 infections and low blood-cell counts occurred in two and six patients, respectively. The ongoing, potentially registrational Phase 2 RECLAIM-LN study uses the same bendamustine conditioning regimen in refractory, moderate-to-severe lupus with nephritis.
Fate Therapeutics (FATE) appointed Jamie Harrell as Senior Vice President, Market Development & Commercial Operations, effective October 12, 2026.
In the newly created role, Harrell will lead commercial and market development strategy across the company's autoimmune disease and oncology programs. He will also shape physician engagement as Fate works toward commercialization. FT819 is being evaluated in RECLAIM-LN, a Phase 2 potentially registrational trial in refractory lupus nephritis. FT839 is in a Phase 1/2 trial across multiple autoimmune indications, including rheumatoid arthritis. Harrell most recently served as Vice President of Marketing and Commercial Operations at Aurinia Pharmaceuticals.
Entera Bio (NASDAQ: ENTX) has appointed Laura Hamill to its Board of Directors, effective December 1, 2026, succeeding Yonatan Malca.
Hamill brings more than 35 years of global commercial, market access and business leadership experience. She most recently served as Executive Vice President, Worldwide Commercial Operations at Gilead Sciences, leading approximately 2,500 employees responsible for $22 billion in annual revenue. Previously, she spent nearly two decades at Amgen, including overseeing commercial activities and supporting functions representing approximately 80% of Amgen’s revenue.
Entera expects her experience to support commercial preparedness for its osteoporosis candidate EB613 and broader pipeline advancement. Malca is stepping down after 16 years of service.
Fate Therapeutics (FATE) granted equity inducement awards to two newly hired non-executive employees on October 1, 2026.
One employee received options to purchase 62,900 common shares at $2.30 per share, matching the Nasdaq closing price on the grant date. Two employees, including the option recipient, received restricted stock units (RSUs) representing 72,700 common shares. The Compensation Committee approved the awards under the Amended and Restated Inducement Equity Plan in accordance with Nasdaq Listing Rule 5635(c)(4). Both award types vest over four years, subject to continued employment through each vesting date.
Fate Therapeutics (FATE) announced that management will participate in two investor conferences during the fourth quarter of 2026.
The Jefferies Global Healthcare Conference runs November 16–19 in London, UK, and the Piper Sandler 38th Annual Healthcare Conference runs December 1–3 in New York, NY. The company may participate in a presentation or fireside chat at these conferences.
Fate Therapeutics (FATE) announced on September 25, 2026, that it received a $15.0 million grant for RECLAIM-LN. The California Institute for Regenerative Medicine (CIRM) awarded the funding through its CLIN2 program to support clinical development of the Phase 2, potentially registrational trial of FT819, an off-the-shelf CAR T-cell therapy.
RECLAIM-LN is studying FT819 in patients with refractory moderate-to-severe systemic lupus erythematosus with lupus nephritis. The study will evaluate the treatment’s safety and efficacy. FT819 is designed to deplete pathological B cells; that intended effect is not a reported trial result.
Fate Therapeutics (FATE) will present four abstracts from its off-the-shelf, iPSC-derived CAR T-cell programs in autoimmune disease at ACR Convergence 2026 in Orlando, November 6-11, 2026.
Two presentations cover FT819, including updated clinical data on administration without conditioning chemotherapy, biomarker associations with quality-of-life improvement, and continued progress toward outpatient, community-based use. A third poster reports focus group findings on patient preferences for allogeneic CAR T-cell therapy in systemic lupus erythematosus. A fourth poster describes preclinical data and design progress for the COMPLETE Phase 1/2 trial of FT839, a dual-CAR T-cell candidate co-targeting CD19 and CD38 in rheumatoid arthritis.
Fate Therapeutics (FATE) will present encore Phase 1 clinical data for FT819, its off-the-shelf anti-CD19 CAR T-cell candidate, in systemic lupus erythematosus (SLE) at the CCR – West meeting on September 18, 2026.
The update covers 16 SLE patients in Regimen A, which uses a single FT819 dose with less-intensive, fludarabine-free conditioning; 13 patients had at least one month of follow-up as of the May 14, 2026 cutoff. No dose-limiting toxicities, no Grade ≥3 cytokine release syndrome, and no cases of ICANS, GvHD, or IEC-HS were observed, with infections and cytopenias described as low and manageable. FT819’s design combines a tuned CAR motif, targeted insertion into the TRAC locus and clonal-level engineering to support safety and product uniformity.
Clinically meaningful improvements were reported in SLE disease activity and fatigue scores, emerging early and persisting over time. In patients with active lupus nephritis at baseline, Month 6 urine protein-to-creatinine ratio decreased by 1.15 g/g across Regimen A and by 1.8 g/g in those receiving a single FT819 dose plus bendamustine, which the company views as a meaningful kidney outcome supporting its Phase 2 RECLAIM-LN trial.
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.