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FLORHAM PARK, N.J. - Cellectar Biosciences, Inc. (NASDAQ:CLRB), a clinical-stage biotech company with a market capitalization of $12.77 million and strong liquidity position according to InvestingPro data, announced Monday that the U.S. Food and Drug Administration has granted rare pediatric drug designation for iopofosine I 131 in treating inoperable relapsed or refractory pediatric high-grade glioma.
The designation complements the FDA’s previous orphan drug designation for the treatment. If approved, Cellectar may be eligible to receive a Priority Review Voucher upon reauthorization of the program. While the company maintains a healthy current ratio of 2.15, InvestingPro analysis indicates rapid cash burn, a crucial factor for investors monitoring clinical-stage biotechs.
Iopofosine I 131 is described as a potential first-in-class cancer targeting agent that uses a phospholipid ether as a radioconjugate monotherapy.
Interim data from the company’s ongoing CLOVER-2 Phase 1b trial showed patients receiving a minimum 55 mCi total administered dose experienced an average of 5.4 months of progression-free survival and 8.6 months of overall survival. According to literature cited in the press release, median progression-free survival and overall survival for patients with relapsed pediatric high-grade glioma is typically around 2.25 months and 5.6 months, respectively.
Three patients who received additional dosing cycles had an average progression-free survival of 8.1 months and overall survival of 11.5 months, with two achieving an objective response.
The most frequently reported treatment-related adverse events were hematologic in nature, including thrombocytopenia, neutropenia and anemia. No treatment-related deaths were reported, according to the company statement.
Pediatric high-grade gliomas are aggressive tumors affecting the brain and central nervous system. The CLOVER-2 trial is being conducted at multiple sites in the United States and Canada to evaluate the safety and tolerability of the treatment in children, adolescents and young adults. With analyst price targets ranging from $18 to $76 and the company’s next earnings report due in 4 days, investors seeking deeper insights can access comprehensive analysis through InvestingPro’s detailed research reports, which cover over 1,400 US stocks including Cellectar Biosciences.
In other recent news, Cellectar Biosciences has reported promising results from preclinical studies of its experimental cancer drug, CLR 225, which demonstrated tumor growth inhibition in pancreatic cancer models. The company shared these findings at a cancer research conference in Boston. Additionally, Cellectar Biosciences has raised approximately $5.8 million through the exercise of existing warrants and the issuance of new inducement warrants. This financial move involved agreements with institutional investors and covered warrants initially issued between October 2022 and July 2025.
Furthermore, Cellectar announced that its cancer treatment, iopofosine I 131, may soon be eligible for Conditional Marketing Authorization in Europe for patients with Waldenstrom macroglobulinemia who have not responded to Bruton Tyrosine Kinase inhibitor therapy. The European Medicines Agency’s Scientific Advice Working Party has suggested that filing for this authorization could be acceptable. If approved, the treatment could be available across 30 European countries by 2027. Meanwhile, SelectR Biosciences reported a net loss of $5.4 million for the second quarter of 2025, missing earnings per share forecasts significantly. Despite the earnings miss, the company’s stock showed resilience in premarket trading.
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