- Trial Phase
- Phase 2 (with Phase 3 confirmatory trial initiating)
- Time to Market
- NDA submission planned for mid-2027; potential accelerated approval decision could follow in late 2027 or early 2028 if accepted
- Why 7/10
- The next hard, dated catalyst is the NDA submission to the FDA planned for mid-2027 (~9 months from now). This is a major milestone for a single-asset company where iopofosine I 131 drives essentially the entire thesis. The company also has CLR 125 (Phase 1b) in its pipeline, so it's not purely single-asset, but iopofosine is clearly the dominant value driver.
Watch for the NDA submission to the FDA (planned mid-2027) and any early data from the Phase 3 confirmatory trial. The stock trades near its 52-week low with a ~$21M market cap — any positive regulatory milestone could drive significant upside, but the company will likely need additional financing before reaching profitability. Monitor cash burn and dilution risk closely.
Price Chart
Executive Summary
iopofosine I 131 (CLR 131) is Cellectar Biosciences' lead radiopharmaceutical candidate targeting Waldenström macroglobulinemia and other B-cell malignancies. Phase 2b CLOVER WaM data showed a 83.6% overall response rate and 61.8% major response rate with median duration of response of 17.8 months, supporting a planned accelerated approval NDA submission to the FDA in mid-2027. The company has initiated site activation for a Phase 3 confirmatory trial. With a ~$21M market cap, $34M cash runway into Q2 2027, and analyst price targets implying ~354% upside, the stock is a high-risk/high-reward binary play on regulatory success. However, significant dilution from the May 2026 offering and the need for additional capital before any revenue materializes are key risks.
How It Works
iopofosine I 131 is a radiopharmaceutical — a drug that combines a cancer-targeting molecule with a radioactive isotope (iodine-131). It works by hitching a ride on a phospholipid ether (a type of fat molecule) that cancer cells absorb more readily than normal cells. Once inside the cancer cell, the iodine-131 emits radiation that damages the cell's DNA and kills it, while largely sparing healthy tissue. Think of it as a guided radiation missile for cancer cells.
Trial Status
Phase 2b CLOVER WaM trial (NCT02952508) in Waldenström macroglobulinemia is active but no longer recruiting (primary completion estimated June 2026). Positive 12-month follow-up data reported in May 2026 showed 83.6% ORR and 61.8% MRR. Site activation for the Phase 3 confirmatory trial began in Q2 2026. The company also has a Phase 1b trial of CLR 125 (a related radioconjugate) in triple-negative breast cancer.
The Two-Sided Case
Upcoming Catalysts
- NDA submission to FDA for accelerated approval in Waldenström macroglobulinemia (planned mid-2027)
- Conditional Marketing Authorization submission in Europe (planned 2026)
- Phase 3 confirmatory trial enrollment updates
- Phase 1b CLR 125 TNBC safety/efficacy data (H2 2026)
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Cellectar Biosciences, Inc. 8-K CLRB ·Originating report