Cellectar Biosciences Expands Global Intellectual Property Estate
Rhea-AI Summary
Cellectar Biosciences (NASDAQ: CLRB) expanded its global intellectual property estate with newly issued patents across Europe, Asia-Pacific, the Middle East, and the Americas. The patents cover iopofosine I 131, CLR-125, imaging of cancer stem cells, and fractionated dosing regimens.
The company said this strengthens protection ahead of a planned 3Q26 filing for conditional marketing authorization of iopofosine I 131 with the European Medicines Agency.
Positive
- New patents issued across Europe, Asia‑Pacific, Middle East, Americas
- Covers iopofosine I 131 and CLR‑125 for therapy and imaging
- Planned EMA filing for conditional marketing authorization in 3Q26
Negative
- No financial, commercial-license, or revenue impact details disclosed
Market Reality Check
Peers on Argus
CLRB up 4.78% alongside 2 momentum peers (e.g., EDSA, BLRX) also moving up with median gains around 7.5%, pointing to broader biotech strength.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 09 | Strategic plans update | Positive | -7.0% | Outlined 2026 priorities and EMA/FDA paths for iopofosine I 131. |
| Dec 16 | Supply agreement | Positive | -0.6% | Signed multi-year Actinium-225 and Astatine-211 supply deal with Ionetix. |
| Nov 13 | Q3 2025 earnings | Neutral | -18.0% | Reported lower loss, clinical progress, but highlighted liquidity and funding risks. |
| Nov 06 | Earnings call notice | Neutral | +2.7% | Announced timing of Q3 2025 results and investor conference call. |
| Oct 27 | Pediatric designation | Positive | -10.3% | Received FDA Rare Pediatric Disease Designation and shared interim trial data. |
Stock has often traded down on prior positive or strategically important news, showing multiple divergences between news tone and price reaction.
Over the last few months, Cellectar reported clinical and regulatory progress for iopofosine I 131, including EMA scientific advice supporting a conditional marketing authorization filing in 2026 and FDA Breakthrough Therapy designation, plus rare pediatric disease designation in high-grade glioma. The company also raised capital through warrant transactions and underwritten offerings, while flagging going-concern risk. Despite these advances, several prior updates with positive elements saw negative next‑day price reactions, contrasting with today’s modest gain on IP expansion.
Market Pulse Summary
This announcement expands Cellectar’s global patent protection for iopofosine I 131 and CLR 125 across major regions, reinforcing its position ahead of a planned 3Q 2026 conditional marketing filing in Europe for Waldenström macroglobulinemia. Set against earlier EMA guidance, FDA Breakthrough designation, and recent financing activity, it underscores a strategy of shoring up exclusivity while advancing late‑stage assets. Investors may watch future regulatory filings, cash disclosures, and clinical updates to gauge execution risk.
Key Terms
conditional marketing approval regulatory
european medicines agency (ema) regulatory
waldenström macroglobulinemia medical
triple negative breast cancer medical
cancer stem cells medical
radiopharmaceutical medical
AI-generated analysis. Not financial advice.
Strengthens Protection Around Broad Portfolio of Cancer-Targeting Drug Conjugates and Enabling Technologies
Provides Key Coverage Across Europe Ahead of Planned 3Q26 Filing for Conditional Marketing Approval with the European Medicines Agency (EMA) for Iopofosine I 131 as a Treatment for Waldenström Macroglobulinemia
FLORHAM PARK, N.J., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced a broad expansion of its global intellectual property (IP) estate, including newly issued patents across Europe, Asia-Pacific, the Middle East, and the Americas. These additions strengthen the company’s protection around iopofosine I 131, its proprietary radiotherapeutic, as well as its broader portfolio, including CLR 125, the company’s Auger-emitting radiopharmaceutical in development as a treatment for triple negative breast cancer.
“We are seeing meaningful and timely momentum across our global IP estate at a truly pivotal moment for the company,” said James Caruso, president and CEO of Cellectar Biosciences. “Securing these patents in major international markets reinforces the uniqueness of our technology and provides critical intellectual property fortification. Following guidance from the EMA’s Scientific Advice Working Party (SAWP) we are advancing our planned filing for conditional marketing authorization of iopofosine I 131 for Waldenström macroglobulinemia in Europe. This strengthened global protection is essential to our long-term commercial strategy—and, more importantly, it supports our commitment to delivering new, desperately needed therapeutic options to patients who continue to face limited treatment choices.”
The expanded IP coverage spans multiple patent families critical to the company’s therapeutic and platform strategies:
- Ether and Alkyl Phospholipid Compounds for Treating Cancer and Imaging Cancer Stem Cells
- Covers iopofosine I 131 and CLR-125 for both therapeutic use and imaging/detection of primary tumors and cancer stem cells.
- Newly issued in Europe, China, Israel, Eurasia, and New Zealand.
- Fractionated Dosing of a Phospholipid Ether Analog for the Treatment of Cancer
- Covers proprietary iopofosine I 131 dosing regimens.
- Newly issued in Eurasia, Israel, Turkey, Mexico, and Canada.
About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects.
The company’s product pipeline includes: iopofosine I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope); CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors, such as triple negative breast (TNBC), lung, and colorectal, and is currently being evaluated in a Phase 1b study for TNBC; CLR 121225 (CLR 225), an actinium-225 based program being targeted to several solid tumors with significant unmet need, such as pancreatic cancer, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.
In addition, iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma, and the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has granted iopofosine I 131 Breakthrough, six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications, and the EMA has granted iopofosine I 131 PRIME.
For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: X, LinkedIn, and Facebook.
Forward Looking Statements Disclaimer
This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to identify suitable collaborators, partners, licensees or purchasers for our product candidates and, if we are able to do so, to enter into binding agreements with regard to any of the foregoing, or to raise additional capital to support our operations, or our ability to fund our operations if we are unsuccessful with any of the foregoing. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2024, and our Form 10-Q for the quarter ended September 30, 2025. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.
INVESTORS:
Anne Marie Fields
Precision AQ
212-362-1200
annemarie.fields@precisionaq.com
FAQ
What patents did Cellectar Biosciences (CLRB) announce on February 17, 2026?
How do the new CLRB patents affect the planned EMA filing for iopofosine I 131 in 3Q26?
Which therapeutic areas do Cellectar's new patents for CLRB cover?
What jurisdictions received newly issued patents from Cellectar Biosciences (CLRB)?
Does the announcement specify commercial deals or financial terms for CLRB's IP expansion?
What specific patent families did Cellectar (CLRB) expand on February 17, 2026?
