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PRINCETON - Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB), a commercial-stage biopharmaceutical company, announced today that its cancer treatment, naxitamab-gqgk (DANYELZA®), has been recommended by the National Comprehensive Cancer Network® (NCCN) as a Category 2A treatment option for patients with high-risk neuroblastoma. The NCCN is an alliance of 33 leading cancer centers that sets guidelines for patient care in oncology. According to InvestingPro data, Y-mAbs has maintained a strong gross profit margin of 83% despite its stock declining 77% over the past year.
The FDA granted accelerated approval to naxitamab-gqgk in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for certain pediatric and adult patients with high-risk neuroblastoma on November 25, 2020. This recommendation was based on response rates seen in patients enrolled in two single-arm, open-label trials.
Naxitamab-gqgk, developed by researchers at Memorial Sloan Kettering Cancer Center and licensed exclusively to Y-mAbs, is indicated for use in pediatric patients one year and older and adults with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have shown a partial response, minor response, or stable disease following prior therapy.
The therapy carries a Boxed Warning for serious infusion-related reactions and neurotoxicity, which includes severe neuropathic pain and transverse myelitis. The continued approval of naxitamab-gqgk may depend on the verification and description of clinical benefits in a confirmatory trial.
Y-mAbs Therapeutics specializes in the development and commercialization of novel radioimmunotherapy and antibody-based therapies for cancer treatment. The company’s product pipeline includes DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for its indicated patient population with neuroblastoma.
This news is based on a press release statement and provides a current update on the status of naxitamab-gqgk within the oncology treatment landscape. It should be noted that while naxitamab-gqgk is now included in the NCCN Guidelines, it is not approved for the treatment of osteosarcoma or any other condition beyond its current indications.
In other recent news, Y-mAbs Therapeutics has initiated a Phase 1 clinical trial for a new treatment targeting non-Hodgkin Lymphoma. The trial is focused on the company’s Self-Assembly and Disassembly Pre-targeted Radioimmunotherapy platform, which aims to deliver targeted radiation to lymphoma cells. Meanwhile, BofA Securities has downgraded Y-mAbs Therapeutics’ stock to Underperform, citing challenges with the company’s flagship product, Danyelza, and potential financial strains. In contrast, Jones Trading has maintained a Buy rating on the stock, although it lowered the price target to $18, reflecting revised revenue guidance for fiscal year 2025. Morgan Stanley also adjusted its price target to $7, maintaining an Underweight rating due to anticipated sales declines. Additionally, Y-mAbs Therapeutics has announced an Equity Distribution Agreement with Oppenheimer & Co. Inc., allowing the potential sale of up to $35 million in common stock. This agreement provides the company with flexibility in financing its operations. Investors will be closely monitoring these developments, particularly the ongoing trials and strategic financial maneuvers, as they may impact the company’s future performance.
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