Fate Therapeutics Inc FATE
Fate Therapeutics Inc (Nasdaq: FATE) is an immunology/inflammation drug developer. Its lead program, FT819 (iPSC-derived CAR T-cell), is in Phase 1 for systemic lupus erythematosus (with and without lupus nephritis).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| FT819 (iPSC-derived CD19 CAR T-cell) | systemic lupus erythematosus | cell therapy | Phase 1 |
| Ono Candidate 2 (iPSC-derived CAR T, solid tumors; co-development with Ono) | solid tumors | cell therapy | Phase 1 |
| FT836 (iPSC-derived CAR T-cell) | not stated in extract (CIRM-funded preclinical/IND-enabling) | cell therapy | Pre-clinical |
| Ono Candidate 3 (iPSC-derived CAR, solid tumors) | solid tumors | cell therapy | Pre-clinical |
Recent results and decisions
- Sep 25, 2026n/a Fate Therapeutics received a $15 million grant from CIRM to support the Phase 2 RECLAIM-LN trial of FT819 in lupus nephritis.
CIRM has awarded the Company a $15.0 million grant, through its CLIN2 program, to support the clinical development of RECLAIM-LN, the Company's Phase 2, potentially registrational trial of FT819 off-the-shelf CAR T cell.
Filing - Aug 13, 2026started First patient dosed in RECLAIM-LN, a single-arm Phase 2 potentially registrational trial of FT819 (~53 patients, CRR at Week 26 primary endpoint); treated as outpatient with same-day discharge.
Dosing of the first patient in RECLAIM-LN, our Phase 2 potentially registrational trial, is an exciting milestone as we work to address significant unmet medical needs in patients with lupus nephritis using our FT819 off-the-shelf CAR T-cell treatment
Filing - Aug 13, 2026n/a FDA cleared the FT839 (CD19/CD38 dual-targeting CAR T) IND, enabling a Phase 1/2 basket trial in autoimmune disease.
Also in July, the FDA cleared the Company’s IND application for FT839, a next-generation, off-the-shelf CAR T-cell product candidate uniquely engineered to co-target CD19 and CD38.
Filing
2 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
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- Phase 2 evidence behind each Phase 3 readout
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Other phase 1 immunology/inflammation companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.