Monitor enrollment updates and interim data readouts from RECLAIM-LN. The RMAT designation and FDA CMC pilot program support accelerated pathway, but no efficacy data expected for 12-18 months. Stock movement likely driven by enrollment pace and any early safety signals.
Price Chart
Executive Summary
Fate Therapeutics announced first patient dosed in the Phase 2 potentially registrational RECLAIM-LN trial of FT819 for lupus nephritis. The trial targets ~53 patients with enrollment expected to complete by 1H2028, supported by RMAT designation and FDA CMC pilot program. This is a positive clinical milestone but no efficacy data is expected for 12-18 months.
Key Facts
- First patient dosed in Phase 2 RECLAIM-LN trial (FT819) for refractory lupus nephritis
- Trial expected to enroll ~53 patients; enrollment completion anticipated by 1H2028
- Primary endpoint: complete renal response at Week 26
- FT819 has RMAT designation and is in FDA CMC Development and Readiness Pilot program
- Patients receive single 900M-cell dose of off-the-shelf FT819 with bendamustine conditioning
Financial Impact
Clinical milestone with no immediate revenue impact; trial enrollment expected to complete by 1H2028. Cash runway into 2028 per prior Q2 filing.
Risk Factors
- Trial enrollment delays or slower-than-expected site activation
- Negative efficacy or safety data from Phase 2
- Dilution risk given cash burn and no revenue
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3345223 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 14, 2026 7w ago | Press Release | $2.57 $2.34 | ▼ −8.95% | ▼ −6.96% | $2.30 (−10.70%) |
Aug 13, 2026 7w ago | 8-K | $2.52 $2.31 | ▼ −8.33% | ▼ −6.59% | $2.30 (−8.93%) |
Aug 5, 2026 8w ago | Insider Cluster | $2.49 $2.42 | ▲ +2.81% | ▲ +3.41% | $2.30 (+7.83%) |
Jun 11, 2026 16w ago | Institutional Cluster | $1.97 $3.11 | ▼ −57.87% | ▼ −55.98% | $2.30 (−16.50%) |
Jun 4, 2026 17w ago | 8-K | $1.98 $2.99 | ▲ +51.01% | ▲ +49.15% | $2.30 (+15.91%) |
Jun 1, 2026 17w ago | Press Release | $2.74 $2.70 | ▼ −1.46% | ▼ −0.16% | $2.30 (−16.24%) |
May 13, 2026 20w ago | 8-K | $2.14 $1.97 | ▼ −7.94% | ▼ −7.33% | $2.30 (+7.24%) |
May 11, 2026 20w ago | Press Release | $2.18 $1.90 | ▼ −12.84% | ▼ −12.54% | $2.30 (+5.28%) |
Apr 24, 2026 22w ago | DEFA14A | $1.31 $2.15 | ▲ +64.12% | ▲ +59.17% | $2.30 (+75.19%) |
US Market Status
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