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NEW YORK - Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB), a biopharmaceutical company specializing in cancer treatments, has announced interim Phase 2 clinical trial results for naxitamab in combination with GM-CSF in patients with high-risk neuroblastoma. The study, published in Nature Communications, demonstrated statistically significant efficacy and a manageable safety profile for the treatment. With a market capitalization of $249 million and impressive gross profit margins of 89%, Y-mAbs maintains a strong financial foundation for its clinical developments, according to InvestingPro data.
The trial focused on patients with relapsed or refractory high-risk neuroblastoma with residual disease in the bone or bone marrow. Naxitamab, an anti-GD2 monoclonal antibody, was administered alongside GM-CSF, showing a 50% overall response rate (ORR) among the 52 participants evaluated. The treatment led to complete responses (CR) in 38% of patients and partial responses (PR) in 12%. Despite these promising clinical results, Y-mAbs’ stock currently trades near its 52-week low of $5.28, significantly below its high of $20.90, presenting what InvestingPro analysis suggests is an undervalued opportunity. Get access to 10+ additional ProTips and comprehensive financial analysis with an InvestingPro subscription.
Patients with evaluable bone disease had a 58% response in the bone compartment, while the bone marrow compartment response was 74%. The study reported one-year overall survival at 93% and progression-free survival at 35%. Notably, patients previously treated with anti-GD2 monoclonal antibodies also responded to naxitamab, with a 31% response rate among this subgroup.
The safety profile of naxitamab was characterized by primarily infusion-related adverse events (AEs), with hypotension being the most significant. Grade 3 pain was frequently observed but typically resolved shortly after infusion.
Dr. Jaume Mora, the lead author from the Pediatric Cancer Center Barcelona, highlighted the study’s robust evidence for targeting residual disease in the bone and bone marrow, which is a common site for chemoresistant cells in this patient population.
Y-mAbs Therapeutics believes that the results support naxitamab as an important treatment option for patients with relapsed and refractory high-risk neuroblastoma. The treatment was developed by researchers at Memorial Sloan Kettering Cancer Center and is exclusively licensed to Y-mAbs. The company maintains a healthy balance sheet with a current ratio of 3.92, indicating strong liquidity to support its ongoing research and development efforts.
The company’s pipeline includes other novel cancer therapies, such as the investigational Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy Platform (PRIT) and bispecific antibodies generated using the Y-BiClone platform. DANYELZA® (naxitamab-gqgk), part of the company’s product pipeline, is the first FDA-approved treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow after prior therapy.
This news article is based on a press release statement from Y-mAbs Therapeutics, Inc. With analyst price targets ranging from $11 to $26, significantly above current trading levels, investors seeking detailed insights can access the comprehensive Pro Research Report available exclusively on InvestingPro, covering all crucial aspects of Y-mAbs’ financial health and market position.
In other recent news, Y-mAbs Therapeutics has been the focus of analyst attention and strategic developments. Oppenheimer reaffirmed its Outperform rating on the company with a price target of $23.00, following an investor dinner that highlighted a strategic realignment. The company’s plan to separate its Danyelza and radiopharmaceutical businesses aims to optimize resource allocation and operational efficiency. This move is expected to lead to significant updates in the second quarter, particularly in the radiopharmaceuticals division.
Meanwhile, Clear Street initiated coverage on Y-mAbs Therapeutics with a Buy rating and a $21.00 price target. The firm emphasized the importance of the company’s commercial product, Danyelza, and the SADA platform, which is seen as a key driver for future growth in the radiotherapy sector. Clear Street’s positive outlook is based on the company’s current financial stability and the potential advancements offered by the SADA platform. These recent developments have drawn increased attention from investors, who are keenly observing the company’s progress in maintaining profitability and advancing new technologies.
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