catalyst calendar
FATE THERAPEUTICS INC · Data as of 2026-10-25
H2 2026
The Company anticipates providing further updates on its clinical progress at European Alliance of Associations for Rheumatology (EULAR) Annual Congress in June of 2026 as well as in other scientific conferences in the second half of 2026.Source filing
2028
RECLAIM-LN: A Phase 2 Potentially Registrational Trial in Lupus Nephritis FT819-201 (RECLAIM-LN) patient enrollment planned to commence in 2H2026 OPEN LABEL, SINGLE ARM STUDY FOR PATIENTS WITH REFRACTORY MODERATE-TO-SEVERE SLE WITH LN1,2 RECLAIM-LN Trial Schema ✓ Single d ose of 900M cells ✓ Less-intensive condit ioning regimen consisting of bendamustin e ✓ Outpatient treatment enabled ✓ Study N= 53 total patients ✓ Validated primary endpoint at 26 weeks ✓ FDA RMAT designat ion & CDRP program There is no Day 0; visit days within the cycle progress from Day -5 to Day -4, followed by Day 1. After FT819 infusion, participants acceptance will be followed in PTFU for up to 2 years after Day 1, followed by LTFU for safety and survival for up to 15 years after Day 1. LTFU = Long-term follow-up; PTFU = Post-treatment follow-up. RECLAIM-LN Trial Features & Design RMAT designation provides enhanced FDA • Single dose of FT819 administered at 900M cells following bendamustine conditioning; each dose engagement and support, strengthening both administration will be supported by on-demand drug product availability clinical & regulatory pathways toward a • Less-intensive fludarabine-free chemotherapy enhances safety, provides a more patient-friendly potential accelerated approval of FT819 experience, and is outpatient enabled • Total enrollment of 53 patients with anticipated commencement of patient dosing in 2H2026; CDRP program acceptance by the FDA aims enrollment expected to complete within 15 months following trial commencement to facilitate the expedited development of • Primary endpoint will assess percent of patients achieving complete renal response (CRR) at 6 months FT819 for accelerated clinical timelines • Trial design informed by feedback received from FDA RMAT meeting RECLAIM-LN potentially registrational trial to be initiated in 2H 2026 with BLA submission targeted in 2028 1. https://clinicaltrials.gov/study/NCT07570862 (ClinicalTrials.gov) RMAT: FDA Regenerative Medicine Advanced Therapy; 2. Learn more about the RECLAIM-LN clinical trial at www.fatetherapeutics.com/patients CDRP: Chemistry, Manufacturing, and Controls Development and Readiness Pilot 16Source filing
Sep 18
Fate Therapeutics, Inc. SAN DIEGO, Sept. 09, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today announced clinical data from its off-the-shelf anti-CD19 CAR T-cell product candidate FT819, and pre-clinical data from its off-the-shelf anti-CD19 and CD38 CAR T-cell product candidate FT839 will be featured at the Congress of Clinical Rheumatology West (CCR – West) meeting, being held in Huntington Beach, CA on September 17-20, 2026. The Company is presenting encore clinical data from the systemic lupus erythematosus (SLE) study arm of its ongoing Phase 1 trial in support of its advancing RECLAIM-LN trial, a Phase 2 potentially registrational trial in lupus nephritis (LN). The presentation includes clinical safety, efficacy and translational data from 16 SLE patients treated in Regimen A of the Phase 1 trial, which is evaluating a single dose of FT819 combined with less-intensive, fludarabine-free conditioning chemotherapy, of whom 13 patients have completed at least one month of follow-up as of May 14, 2026 data cutoff. Highlights of the FT819 presentation include: Favorable Tolerability: Among SLE patients treated in Regimen A, there were no dose-limiting toxicities, no cytokine release syndrome of Grade 3 or greater, and no cases of immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease (GvHD), or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS). In addition, low and manageable rates of infection and cytopenia were observed. Designed for Safety: In addition to the use of less-intensive conditioning, which is intended to reduce the frequency of adverse events associated with lymphodepletion, FT819 incorporates multiple design attributes intended to support a favorable safety profile, including the combination of a novel tuned CAR motif and targeted insertion into the TRAC locus designed to prevent uncontrolled T-cell expansion, and precise engineering at the clonal level with a well-vetted master cell bank serving as the consistent starting point for routine manufacture to ensure drug product uniformity and reliability. Combined, these attributes incorporated at the molecular-, manufacture- and clinical-level are designed to provide a unique, planned advantage, with the goal of treating patients with CAR T cells in an effective yet safe manner. Early and Maintained Efficacy: As of the cutoff date, clinically meaningful improvements were observed in lupus disease activity and patient-reported outcome measures, including Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue scores, in patients treated in the Phase 1 trial. Improvements were observed early following treatment with FT819 using less-intensive conditioning therapy in Regimen A (≥1-month follow-up) and were maintained over time. Phase 1 Data Applicable to RECLAIM-LN: Month 6 UPCr levels in patients with active LN at baseline decreased by 1.15 g/g in all patients treated in Regimen A and, specifically, decreased by 1.8 g/g in patients treated with a single dose of FT819 and bendamustine, representing a meaningful therapeutic mark in the management of kidney disease. FT819 Presentation Title: Safety and Efficacy of an Off-the-Shelf Anti-CD19 CAR T-Cell Therapy with Reduced Conditioning in SLE Supporting Same-Day Discharge Presentation Date / Time : Friday, September 18, 2026, at 3:40 p.m. PT FT839 Presentation Title: Off-the-Shelf Dual-CAR T-Cell Therapy: Targeting B and T Cells in Autoimmune Disease Without Preconditioning Presentation Date / Time : Friday, September 18, 2026, at 3:40 p.m. PT Presentation materials will be available following the event on the Fate website located here: Fate Publications & Presentations About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company's pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company's product candidates, clinical studies and preclinical research and development programs, the Company's progress, plans and timelines for the clinical investigation of its product candidates, including the Company's plans to submit IND applications for its product candidates, the initiation and continuation of enrollment in the Company's clinical trials, the initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company's product candidates, the availability of data from the Company's clinical trials and the Company's plans to provide updates on its clinical trials, the therapeutic and market potential of the Company's research and development programs and product candidates, the Company's clinical and product development strategy, and the Company's progress and plans relating to, and the anticipated timing and outcome of, interactions with the FDA and other regulatory authorities. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company's research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company's product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company's product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company's product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company's ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company's product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, and risks relating to regulatory interactions and the outcome of such interactions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company's periodic filings with the Securities and Exchange Commission, including but not limited to the Company's most recently filed periodic report, and from time to time in the Company's press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise. Contact: Ryan Douglas Fate Therapeutics, Inc. IR@fatetherapeutics.comSource filing