Y-Mabs Therapeutics ((YMAB)) announced an update on their ongoing clinical study.
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Y-Mabs Therapeutics is conducting a pivotal Phase 2 trial titled ‘A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow.’ The study aims to evaluate the effectiveness of naxitamab combined with GM-CSF in treating high-risk neuroblastoma patients who have not responded to previous treatments. This trial is significant as it targets a challenging patient group with limited treatment options.
The intervention being tested is a combination of two biological agents: GM-CSF and naxitamab. Naxitamab is a humanized monoclonal antibody targeting GD2, while GM-CSF is used to stimulate the immune system. Together, they are intended to improve treatment outcomes for neuroblastoma patients.
The study follows a single-group, open-label design, meaning all participants receive the same treatment without a placebo group. The primary purpose is treatment, focusing on safety and efficacy over a period of up to 101 weeks, with follow-up extending up to five years.
The trial began on November 6, 2017, and is currently recruiting participants. The last update was submitted on August 12, 2025. These dates are crucial for tracking the study’s progress and potential upcoming results.
The ongoing study could influence Y-Mabs Therapeutics’ stock performance positively if results show significant efficacy, potentially increasing investor confidence. In the competitive landscape of neuroblastoma treatments, successful outcomes could position Y-Mabs as a leader, impacting market dynamics.
The study is ongoing, and further details are available on the ClinicalTrials portal.