Fate Therapeutics Showcases FT819 Clinical Activity in SLE without the use of Conditioning Chemotherapy at the 2026 ASGCT Annual Meeting
Rhea-AI Summary
Fate Therapeutics (NASDAQ:FATE) is presenting new data on its off-the-shelf CAR T-cell therapies FT819, FT839, and FT836 at the 2026 ASGCT meeting.
FT819 Phase 1 SLE data show clinical responses without conditioning chemotherapy; FT839 and FT836 preclinical results demonstrate broad immune-cell targeting and tumor control with Sword and Shield™ engineering.
AI-generated analysis. Not financial advice.
Positive
- None.
Negative
- None.
News Market Reaction – FATE
On the day this news was published, FATE declined 8.79%, reflecting a notable negative market reaction. Argus tracked a peak move of +3.1% during that session. Argus tracked a trough of -7.6% from its starting point during tracking. Our momentum scanner triggered 14 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $25M from the company's valuation, bringing the market cap to $260.47M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
FATE is down 1.65% with mixed peer action: CRBP up 0.74%, while EQ, FBRX, KALA, and TARA are down between 1.31% and 7.44%, suggesting stock-specific trading rather than a unified sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| May 05 | FT819 FDA CDRP | Positive | +31.1% | FT819 selected for FDA CDRP to support Phase 2 manufacturing readiness. |
| May 04 | ASGCT preview | Positive | +17.6% | Announcement of three 2026 ASGCT presentations across FT819, FT839, and FT836. |
| May 01 | Inducement RSU grant | Neutral | +17.6% | 30,200 RSUs granted to a new hire under the inducement equity plan. |
| Apr 30 | FT819 CCR–East data | Positive | +0.8% | CCR–East presentation of FT819 SLE data showing clinical and fatigue improvements. |
| Apr 16 | FT839 AACR data | Positive | +6.2% | AACR presentation announcement for FT839 dual‑CAR preclinical data using Sword and Shield. |
Recent pipeline and regulatory updates have generally seen positive price alignment, especially FT819- and FT839-related news.
Over the last month, Fate Therapeutics has repeatedly highlighted its off‑the‑shelf CAR T pipeline. FT819 manufacturing support via the FDA CDRP program on May 5, 2026 and prior ASGCT presentation previews on May 4, 2026 led to price gains of 31.11% and 17.65%. Earlier, FT819 SLE data at CCR–East and FT839 AACR preclinical data were also followed by positive reactions. Against this backdrop, the detailed ASGCT data release on FT819, FT839, and FT836 extends the same themes of conditioning‑free, off‑the‑shelf cell therapies for autoimmune disease and cancer.
Market Pulse Summary
The stock moved -8.8% in the session following this news. A negative reaction despite data-rich ASGCT presentations would contrast with earlier FT819 and FT839 updates, which saw gains up to 31.11%. The market may at times reassess execution, financing, or overall biotech risk even when study readouts appear constructive. Prior filings, including insider exercises and major-holder restructurings, underscore an evolving ownership base that can amplify moves around news without changing the underlying clinical trajectory.
Key Terms
conditioning chemotherapy medical
systemic lupus erythematosus medical
car t-cell medical
iPSC-derived medical
phase 1 medical
xenograft tumor models medical
monoclonal antibodies medical
standard-of-care medical
AI-generated analysis. Not financial advice.
Single dose treatment of FT819 without conditioning chemotherapy achieves lupus low disease activity state (LLDAS) in active SLE Patients; durable B cell remodeling is exhibited by depletion of major B cell clones up to 12 months following treatment with B cell shift towards less class-switched BCR repertoire
Preclinical data for FT839 demonstrate comprehensive targeting of multicellular disease across autoimmune and hematological malignancies; data shows broad and selective depletion of pathogenic immune cell subtypes in rheumatoid arthritis and systemic lupus erythematosus disease without the use of conditioning chemotherapy
Preclinical data for FT836 shows effective elimination of broad range of cancers in synergy with SOC treatments; radiotherapy and chemotherapy significantly enhance FT836 cytolytic activity and specific trafficking to the tumor site
SAN DIEGO, May 11, 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 broadly to patients with cancer and autoimmune diseases, is presenting data this week featuring its off-the-shelf CAR T-cell programs FT819, FT839, and FT836 at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting to be held in Boston, MA, May 11–15, 2026.
“We are excited to highlight our leadership in delivering off-the-shelf CAR T cells with less-intensive or no conditioning chemotherapy to ensure broad patient accessibility,” said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. “With FT819, we are demonstrating that it is feasible to drive CAR T-cell efficacy with less-intensive or no conditioning chemotherapy in SLE and believe that eliminating the need for intensive conditioning chemotherapy has the potential to significantly improve the safety and clinical benefit of cellular therapies. With our next generation CAR T-cell programs, FT836 and FT839, we are illustrating that through precise multiplexed-engineering of iPSCs to generate clonal master banks that serve as the starting point for large scale manufacture of uniform and consistent drug product, it is feasible to tackle complex multicellular diseases, support functional persistence without the need for intensive conditioning chemotherapy, and create synergy with standard-of-care therapies to deliver effective treatments for patients with unmet need.”
Presentation Summaries Include:
Title: FT819 Drives B cell Compartment Remodeling of Patients with Systemic Lupus Erythematosus Without Conditioning Chemotherapy; Poster Presentation Date / Time: Tuesday, May 12, 5:00 PM – 6:30 PM ET
FT819 is the Company’s off-the-shelf, CD19-targeted, iPSC-derived CAR T-cell program, which is currently being investigated in a Phase 1 study for patients with moderate-to-severe systemic lupus erythematosus (SLE) including lupus nephritis and extrarenal lupus (NCT06308978). Data presented this week shows that in Regimen B of the Phase 1 study with a data cutoff of April 9, 2026, a single dose of FT819 without conditioning chemotherapy and in the presence of background therapy demonstrated meaningful clinical responses at dose level 1 in patients with active SLE, with 3 of 3 patients achieving systemic lupus erythematosus responder index (SRI-4) and 2 of 3 patients achieving lupus low disease activity state (LLDAS). The positive clinical outcomes were supported mechanistically by the observation that B cells in the periphery as well as in secondary lymphoid tissue (nasopharyngeal swabs) were significantly depleted. Notably, depletion (
Title: FT839: A Multi-Antigen Targeting Off-the-Shelf dual-CAR T cell for the Treatment of Pathogenic B and T Cells in Autoimmune Diseases; Oral Presentation Date / Time: Thursday, May 14, 8:30 AM - 8:45 AM ET
FT839 is a next generation, off-the-shelf dual CAR T-cell therapy targeting CD19 and CD38 to deplete multiple pathogenic immune cell populations that drive hematological and complex autoimmune diseases, including rheumatoid arthritis (RA), type I diabetes, and multiple sclerosis. Preclinical data to be presented show broad, selective depletion of pathogenic immune cell subtypes in RA and SLE disease samples, including over
Title: CAR T cells Targeting pan-Tumor Antigens MICA/B can be Uniquely Combined with SOC Treatments without Conditioning Chemotherapy for Broad and Effective Therapeutic Application in Cancer; Poster Presentation Date / Time: Wednesday, May 13, 5:00 PM - 6:30 PM ET
FT836 is a next generation, off-the-shelf CAR T-cell therapy that targets the novel and inducible pan-tumor antigens MICA/B. FT836 is engineered to enable rational combination with SOC therapeutics such as mAbs, chemotherapy, radiotherapy, and immune modulators across both hematological malignancies and solid tumor settings. Integrated engineered elements, including Sword and Shield™ technology, support broader and more universal application without the requirements for conditioning chemotherapy. Preclinical data to be presented demonstrate potent and durable control of multiple solid and liquid xenograft tumor models of varying origin and antigen expression by FT836 activity as a monotherapy or in combination with mAbs, such as trastuzumab, cetuximab, or daratumumab (up to
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
About FT819
FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population. This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state agency in California that supports research in regenerative medicine, stem cell therapy, gene therapy, and clinical trials. (Grant number: CLIN2-16303)
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, including its expectations relating to alignment with regulatory authorities on potential registrational pathways for FT819. 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.
Ryan Douglas
Fate Therapeutics, Inc.
IR@fatetherapeutics.com
