LEGN Legend Biotech Corp
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Executive Summary
Legend Biotech announced initial Phase 1 data for LB2501, a first-in-class in vivo CD19/CD20 dual-targeting CAR-T therapy, showing a 100% ORR and 83.3% CR at dose level 2 in relapsed/refractory B-cell NHL, with no DLTs, SAEs, or ICANS. The data will be presented at EHA 2026 on June 14, 2026. This is an early-stage, small-sample (n=12) readout that validates the in vivo CAR-T platform but requires longer follow-up and larger cohorts to confirm durability and scalability.
Actionable Insight
The 100% ORR and 83.3% CR at DL2 in heavily pretreated R/R NHL patients is a strong early signal for the in vivo CAR-T platform, but the tiny sample (n=6 at DL2) and short median follow-up (2.2 months) mean durability is unproven. The EHA presentation on June 14 may provide additional detail. Monitor for longer-term follow-up data and expansion cohorts before assigning full value to the platform.
Key Facts
- LB2501 is a potential first-in-class in vivo CD19/CD20 dual-targeting CAR-T therapy administered as a single IV infusion without lymphodepletion
- At DL2 (n=6), ORR was 100% (6/6) and CR was 83.3% (5/6) in relapsed/refractory B-cell NHL patients with median 3 prior therapy lines
- No dose-limiting toxicities, serious adverse events, or deaths were observed; CRS was all Grade ≤2; no ICANS reported
- Dose-dependent in vivo CAR-T expansion confirmed; CAR-T cells detectable in peripheral blood for up to 116 days
- Median follow-up for DL2 was only 2.2 months (range 2.0–3.8); all responses were ongoing at data cutoff
- Data to be presented as a late-breaking oral at EHA 2026 on June 14, 2026
Financial Impact
No financial figures reported; early clinical data with no revenue or cost disclosures
Risk Factors
- Very small sample size (n=12 total, n=6 at DL2) — efficacy and safety may not replicate in larger cohorts
- Median follow-up of only 2.2 months at DL2 — response durability is unknown
- In vivo CAR-T is a novel modality with no approved precedent; regulatory and manufacturing scalability are unproven
- All responses were ongoing at cutoff, but waning or relapse could occur with longer follow-up
Market Snapshot
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001171843-26-003866 |
| Exhibit: exh_992.htm | 0001171843-26-003866 |
| Document: f6k_060126.htm | 0001171843-26-003866 |
| Document: 0001171843-26-003866-index-headers.html | 0001171843-26-003866 |
| Document: 0001171843-26-003866-index.html | 0001171843-26-003866 |
| Document: 0001171843-26-003866.txt | 0001171843-26-003866 |
Filters
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Jun 2, 2026
10d ago
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6-K
| $36.28 $35.98 | ▼ −0.83% | ▼ −0.13% | $35.87 (−1.13%) |
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Jun 2, 2026
10d ago
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Press Release
| $36.28 $35.98 | ▼ −0.83% | ▼ −0.13% | $35.87 (−1.13%) |
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Jun 1, 2026
11d ago
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6-K
| $25.51 $36.28 | ▲ +42.22% | ▲ +42.07% | $35.87 (+40.61%) |
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Jun 1, 2026
11d ago
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Press Release
| $25.51 $36.28 | ▲ +42.22% | ▲ +42.07% | $35.87 (+40.61%) |
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May 21, 2026
22d ago
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6-K
| $29.37 $29.53 | ▲ +0.54% | ▼ −0.04% | $35.87 (+22.13%) |
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May 21, 2026
22d ago
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Press Release
| $29.37 $29.53 | ▲ +0.54% | ▼ −0.04% | $35.87 (+22.13%) |
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May 12, 2026
4w ago
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6-K
| $28.26 $28.67 | ▲ +1.45% | ▲ +0.88% | $35.87 (+26.93%) |
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May 12, 2026
4w ago
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Press Release
| $28.26 $28.67 | ▲ +1.45% | ▲ +0.88% | $35.87 (+26.93%) |
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Apr 28, 2026
6w ago
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Press Release
| $23.56 $22.77 | ▼ −3.35% | ▼ −3.34% | $35.87 (+52.25%) |
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Apr 14, 2026
8w ago
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6-K
| $18.69 $20.52 | ▲ +9.79% | ▲ +9.02% | $35.87 (+91.92%) |
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