FATE - Fate Therapeutics, Inc.
First-of-Kind, Dual-CAR T cell Targeting CD19 and CD38 for Comprehensive Elimination of Complex, Multi-System Autoimmune Disorders Advances into Phase 1/2 Clinical Development
SAN DIEGO, July 06, 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 disease, today announced that preliminary clinical data from the Company's off-the-shelf CAR T-cell product candidate, FT819, will be presented at the International Society for Stem Cell Research (ISSCR) 2026 Annual Meeting, being held at the Palais des congrès de Montréal in Montréal, Canada on July 8 - 11, 2026.
SAN DIEGO, July 06, 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 disease, today announced that preliminary clinical data from the Company's off-the-shelf CAR T-cell product candidate, FT819, will be presented at the International Society for Stem Cell Research (ISSCR) 2026 Annual Meeting, being held at the Palais des congrès de Montréal in Montréal, Canada on July 8 - 11, 2026.
SAN DIEGO, July 01, 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 that management will participate in the following investor conferences in the third quarter of 2026.
Fate Therapeutics is a bet on their off-the-shelf cell therapies, which are now mostly centered on FT819 for lupus nephritis. I believe FT819 has made good progress since the last time I covered the stock. They've reported broader autoimmune data and are now planning RECLAIM-LN. Unfortunately, I think their recent removal from the Russell 3000 index could be a near-term headwind for the stock price itself.
Accomplished global commercial operations leader brings deep experience launching and scaling biopharmaceutical products as Fate advances its pipeline toward commercialization Accomplished global commercial operations leader brings deep experience launching and scaling biopharmaceutical products as Fate advances its pipeline toward commercialization
SAN DIEGO, June 15, 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, today announced the appointment of Laura Hamill to its Board of Directors.
FT819 off-the-shelf CAR T-cell therapy product candidate continues to broaden patient access with 21 SLE patients now treated, including as outpatient administration in community hospitals Continued demonstration of rapid and sustained clinical improvement with favorable tolerability profile observed following treatment of systemic lupus erythematosus (SLE) patients with FT819 and less-intensive conditioning chemotherapy; a majority of evaluable patients on background glucocorticoids achieved either complete glucocorticoid discontinuation or guideline-based tapering targets FT819 demonstrated deep B-cell depletion with reconstitution of preferred less-differentiated state associated with a healthier repertoire of B cells; elimination of dominant B-cell clones in dose-dependent manner was seen while vaccination titers were maintained In preclinical studies, FT839 exhibited comprehensive elimination of activated immune cells in rheumatoid arthritis patient samples; activity accomplished while in allogeneic setting without the need for conditioning chemotherapy SAN DIEGO, June 04, 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 disease, presented data today featuring its off-the-shelf CAR T-cell programs FT819 and FT839 at the European Congress of Rheumatology (EULAR) annual meeting being held in London, UK, June 3-6, 2026. “The data presented for FT819 with less-intensive conditioning and off-the-shelf CAR T-cell therapy product candidate in SLE is truly exciting, and we are very pleased that our highly-differentiated therapeutic approach has the potential to transform autoimmune disease outcomes by supporting persistent reductions in cSLEDAI, PGA, FACIT-fatigue, and UPCr scores and promoting effective B-cell depletion with preferred subtype reconstitution while maintaining a distinctly favorable tolerability profile,” said Bob Valamehr, Ph.D.
SAN DIEGO, June 02, 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, today announced that on June 1, 2026, the Company granted restricted stock units (RSUs) representing 67,300 shares of its common stock to two newly-hired non-executive employees. The grants were approved by the Compensation Committee of the Company's Board of Directors and granted under the Company's Amended and Restated Inducement Equity Plan as an inducement material to the new employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The RSUs will vest over four years, with 25% of the shares underlying each RSU award vesting on each anniversary of the grant date, subject to the employees being continuously employed by the Company through each vesting date.
FT836 demonstrates meaningful reduction in target lesions without the use of conditioning chemotherapy in metastatic colorectal cancer Detection of FT836 in the peripheral blood and tumor tissue illustrates the unique ability to traffic to tumor site and functionally persist without the reliance on conditioning chemotherapy in allogeneic patient setting SAN DIEGO, June 01, 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, presented clinical data this weekend featuring its off-the-shelf CAR T-cell program FT836 at the American Society of Cancer Oncology (ASCO) Annual Meeting being held in Chicago, IL, May 29 – June 2, 2026. "Early Phase 1 data for FT836 represents a truly exciting moment for patients with certain advanced solid tumors who have exhausted their treatment options” said Bob Valamehr, Ph.D.
/PRNewswire/ -- USA News Group Market Commentary - Start with the number that makes everyone do a double take. As of mid-May 2026, GT Biopharma (NASDAQ: GTBP)
SAN DIEGO, May 21, 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 that data from its off-the-shelf CAR T-cell programs will be featured at the American Society of Cancer Oncology Annual Meeting to be held in Chicago, IL, May 29 – June 2, 2026 and at the European Congress of Rheumatology being held in London, UK, June 3-6, 2026.
Fate Therapeutics (FATE) came out with a quarterly loss of $0.26 per share versus the Zacks Consensus Estimate of a loss of $0.29. This compares to a loss of $0.32 per share a year ago.
RECLAIM – LN, a Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis, on schedule to initiate in the 2 nd half of 2026
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
FDA Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program supports the acceleration of manufacturing readiness for therapies with expedited clinical development timelines Current Regenerative Medicine Advanced Therapy (RMAT) designation and CDRP participation provide opportunity for expedited regulatory pathway and advancement of FT819 Phase 2 potentially registrational clinical trial in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis SAN DIEGO, May 05, 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, today announced that the U.S. Food and Drug Administration (FDA) has selected FT819 for participation in the Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) Program for treatment of moderate to severe systemic lupus erythematosus (SLE). The FDA CDRP Program is a highly selective initiative, with no more than nine proposals accepted annually across the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).
SAN DIEGO, May 04, 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 that data from its off-the-shelf CAR T-cell programs FT819, FT839, and FT836, will be featured at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting to be held in Boston, MA, May 11–15, 2026. Fate Therapeutics will present clinical and translational data from the systemic lupus erythematosus (SLE) arm of its ongoing Phase 1 trial evaluating FT819 in Regimen B, where FT819 is added to background maintenance therapy without the use of conditioning chemotherapy to drive B cell depletion and improve patient outcome.
SAN DIEGO, May 01, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today announced that on May 1, 2026, the Company granted restricted stock units (RSUs) representing 30,200 shares of its common stock to one newly-hired non-executive employee.
SAN DIEGO, May 01, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today announced that on May 1, 2026, the Company granted restricted stock units (RSUs) representing 30,200 shares of its common stock to one newly-hired non-executive employee. The grant was approved by the Compensation Committee of the Company's Board of Directors and granted under the Company's Amended and Restated Inducement Equity Plan as an inducement material to the new employee entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The RSUs will vest over four years, with 25% of the shares underlying each RSU award vesting on each anniversary of the grant date, subject to the employee being continuously employed by the Company through each vesting date.
SAN DIEGO, April 30, 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 that clinical data from the Company's off-the-shelf CAR T-cell product candidate, FT819, will be featured at the Congress of Clinical Rheumatology – East meeting, being held in Destin, FL on April 30 - May 3, 2026. The Company is participating in a Poster Rounding Session and will present an encore of its clinical data from the systemic lupus erythematosus (SLE) study arm of its ongoing Phase 1 trial evaluating FT819 in various autoimmune diseases.