Fate Therapeutics, Inc. FATE
Fate Therapeutics, Inc. (Nasdaq: FATE) is an immunology/inflammation drug developer. Its lead program, FT819, is in Phase 2 for Systemic lupus erythematosus with Lupus Nephritis. Its next catalyst on record is FT819: Phase 1 study supported by CIRM award period (March 2028).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: FT819 — Phase 1 study supported by CIRM award period (March 2028). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| FT819 | Systemic lupus erythematosus (SLE) with Lupus Nephritis (LN) | cell therapy | Phase 2 |
| FT819 | Systemic lupus erythematosus (general) | cell therapy | Phase 1 |
| Candidate 2 | Solid tumors | cell therapy | Phase 1 |
| Candidate 3 | Solid tumors | cell therapy | Pre-clinical |
| FT836 | Undisclosed | cell therapy | Pre-clinical |
Recent results and decisions
- Nov 5, 2026positive Preliminary Phase 1 data for FT819 with bendamustine conditioning demonstrated 100% renal response in 29 autoimmune patients, with favorable safety profile continuing to support RECLAIM-LN Phase 2 trial.
Preliminary Phase 1 clinical data presented at ASN Kidney Week 2026 demonstrated 100% renal response in the bendamustine conditioning regimen selected for RECLAIM-LN
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, 2026positive Phase 1 SLE data (21 treated, EULAR 2026): well tolerated with no Grade >2 CRS, ICANS or GvHD in 16 patients on less-intensive conditioning; 5 of 10 evaluable patients on steroids stopped them entirely.
Among the 16 patients receiving FT819 with less-intensive conditioning (Regimen A), the therapy was well tolerated, with no dose-limiting toxicities, no Grade >2 cytokine release syndrome (CRS), no immune effector cell-associated neurotoxicity syndrome (ICANS), and no graft-versus-host disease (GvHD
Filing
3 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
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 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.