FDA grants breakthrough status to Cellectar’s cancer drug

Published 04/06/2025, 13:24
FDA grants breakthrough status to Cellectar’s cancer drug

This news is based on a press release statement and contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Analysts following the company have set price targets ranging from $3 to $13, though InvestingPro indicates the company is currently trading near its Fair Value. For deeper insights into Cellectar’s financial health, growth prospects, and 12 additional ProTips, investors can access the comprehensive Pro Research Report available on InvestingPro. Analysts following the company have set price targets ranging from $3 to $13, though InvestingPro indicates the company is currently trading near its Fair Value. For deeper insights into Cellectar’s financial health, growth prospects, and 12 additional ProTips, investors can access the comprehensive Pro Research Report available on InvestingPro. WM is a primary subtype of lymphoplasmacytic lymphoma, for which there is currently no cure, and treatment options are limited.

The designation was supported by data from the Phase 2 CLOVER WaM study, which showed an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2%. These results surpassed the primary endpoint target of a 20% MRR. The findings were presented at the 66th Annual American Society of Hematology Conference in December 2024. InvestingPro analysis reveals that while the company maintains a healthy current ratio of 2.47 and holds more cash than debt, it is rapidly burning through its cash reserves.

The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of medicines targeting serious or life-threatening diseases and is based on preliminary clinical evidence that suggests the treatment may provide significant improvement over existing therapies.

Cellectar has also been granted Fast Track and Orphan Drug Designations by the FDA and the European Medicines Agency (EMA) for iopofosine I 131. Additionally, the EMA has granted PRIME Designation for the treatment of r/r WM.

In a separate announcement, Cellectar revealed that it has submitted a data package to the EMA, including preclinical, regulatory, and manufacturing data, along with safety and efficacy results from the CLOVER WaM Phase 2b clinical trial. The EMA will review this information to determine if Cellectar can apply for a fast-track conditional marketing authorization. A decision from the EMA is anticipated by late July 2025.

Cellectar Biosciences focuses on leveraging its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop cancer cell-targeting treatments. The company’s pipeline includes other targeted radiotherapeutic agents and partnered PDC assets.

This news is based on a press release statement and contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected.

In other recent news, SelectR Biosciences reported a significant improvement in its financial performance for the first quarter of 2025. The company reduced its net loss to $6.6 million, or $0.14 per share, compared to a $26.6 million loss, or $0.91 per share, in the same period the previous year. This improvement highlights SelectR’s efforts to streamline operations, with reductions in both research and development expenses and general and administrative costs. The company ended the quarter with $13.9 million in cash and cash equivalents, down from $23.3 million at the end of 2024. SelectR is actively pursuing accelerated approval for its iapoficine I-131 program, with plans for a Phase III trial. The company has engaged Oppenheimer as an exclusive financial advisor to explore strategic alternatives, including potential mergers and acquisitions. Additionally, SelectR is seeking conditional approval from the European Medicines Agency for its iapoficine I-131 program, with a decision expected by the third quarter of 2025.

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