CLRB Cellectar Biosciences, Inc.
Price Chart
Executive Summary
Cellectar Biosciences announced updated 12-month follow-up data from its Phase 2b CLOVER WaM trial of iopofosine I 131 in Waldenström macroglobulinemia, showing 83.6% ORR and 61.8% MRR with median DoR of 17.8 months. The FDA-requested dataset strengthens the case for accelerated approval, and the company plans to initiate a confirmatory study in Q4 2026, supported by a recently announced oversubscribed financing of up to $140M.
Key Financial Metrics
Actionable Insight
The mature 12-month data and strong financing remove key near-term funding and regulatory uncertainty. Watch for ASCO presentation (May 29-June 2) and confirmatory study initiation in Q4 2026 as the next catalysts. The stock's $12M market cap suggests significant upside if accelerated approval is granted, but binary regulatory risk remains.
Key Facts
- 83.6% overall response rate (ORR) and 61.8% major response rate (MRR) in 55-patient per-protocol population
- Median duration of response (DoR) of 17.8 months and median progression-free survival (PFS) of 13.5 months
- In BTKi-exposed patients (n=39): MRR 64.1%, median DoR 18.2 months, median PFS 15.9 months
- In BTKi-refractory patients (n=33): MRR 63.6%, median DoR 18.2 months, median PFS 14.8 months
- FDA-requested ≥12-month follow-up completed on all patients, meeting key regulatory expectation for accelerated approval
- Company plans to initiate confirmatory randomized study in Q4 2026 with PFS as primary endpoint
- Recently announced oversubscribed financing of up to $140M with healthcare institutional investors supports confirmatory study and NDA filing
- No significant bleeding events and low infection rates (<10%) reported; safety profile manageable
- Data accepted for presentation at ASCO 2026 (May 29-June 2)
Financial Impact
Up to $140M in new financing announced; total addressable market for third-line+ WM therapy estimated at ~5,700 patients with no FDA-approved BTKi post-progression options
Risk Factors
- Accelerated approval not guaranteed; FDA may require additional data or reject submission
- Confirmatory study may fail to meet PFS endpoint, risking withdrawal of any accelerated approval
- Heavily pretreated population (median 4 prior lines) may limit commercial adoption if real-world outcomes differ
- Dilution risk from up to $140M financing; exact terms not yet disclosed
- Small market cap ($12M) amplifies volatility on any news
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3287522 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
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Jun 1, 2026
8d ago
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Press Release
| $2.97 $2.59 | ▼ −12.79% | ▼ −10.04% | $2.51 (−15.49%) |
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May 29, 2026
11d ago
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S-1/A
| $3.14 $2.60 | ▲ +17.20% | ▲ +16.90% | $2.51 (+20.06%) |
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May 28, 2026
12d ago
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DEFA14A
| $3.14 $2.59 | ▼ −17.52% | ▼ −15.02% | $2.51 (−20.06%) |
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May 19, 2026
21d ago
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S-1
| $3.17 $3.14 | ▲ +0.95% | ▲ +2.18% | $2.51 (+20.82%) |
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May 14, 2026
26d ago
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8-K
| $3.20 $3.17 | ▼ −0.94% | ▼ −0.22% | $2.51 (−21.56%) |
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May 14, 2026
26d ago
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Press Release
| $3.20 $3.17 | ▼ −0.94% | ▼ −0.22% | $2.51 (−21.56%) |
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May 11, 2026
29d ago
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Press Release
| $3.06 $3.14 | ▲ +2.61% | ▲ +2.70% | $2.51 (−17.97%) |
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May 8, 2026
4w ago
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8-K
| $3.10 $3.20 | ▼ −3.23% | ▼ −1.76% | $2.51 (+19.03%) |
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May 7, 2026
4w ago
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Insider Cluster
| $3.30 $2.94 | ▲ +10.91% | ▲ +12.41% | $2.51 (+23.94%) |
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May 6, 2026
4w ago
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424B5
| $3.53 $2.92 | ▲ +17.28% | ▲ +18.41% | $2.51 (+28.90%) |
US Market Status
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