Y-mAbs Therapeutics
Y-mAbs Therapeutics is a commercial-stage biopharmaceutical company focused on developing and commercializing antibody-based therapeutic products for cancer treatment, including the FDA-approved DANYELZA® for neuroblastoma.
Company Overview
Y-mAbs Therapeutics is a commercial-stage biopharmaceutical company dedicated to developing and commercializing novel, antibody-based therapeutic products for cancer treatment. The company aims to be a leader in producing safer oncology products targeting unmet pediatric and adult medical needs. Its broad product pipeline includes pivotal-stage candidates targeting various cancers, including neuroblastoma, CNS/LM, osteosarcoma, DIPG, medulloblastoma, and DSRCT.
Antibody-Based Therapeutic Products
Y-mAbs Therapeutics' product portfolio features advanced antibody-based treatments. Among these is DANYELZA® (naxitamab-gqgk), designed to treat pediatric patients aged 1 and older, as well as adults, with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow. DANYELZA® has received accelerated approval based on response rates and duration. The company also uses pioneering technology platforms like Y-BiClone for bispecific antibodies and the SADA Pretargeted Radioimmunotherapy Platform (PRIT) for targeted therapies.
Collaborations and Partnerships
Y-mAbs Therapeutics has strategic partnerships with notable institutions such as Memorial Sloan Kettering Cancer Center (MSKCC) and the Massachusetts Institute of Technology. These collaborations enhance the company's technological capabilities, particularly in developing the SADA PRIT technology platform. The company's use of licensed technologies from MSKCC exemplifies its commitment to advancing innovative immunotherapies to combat cancer.
Financial Performance
As of the first quarter of 2024, Y-mAbs Therapeutics reported U.S. DANYELZA® net product revenues of $18.6 million and worldwide revenues of $19.4 million. With cash and cash equivalents amounting to $75.7 million as of March 31, 2024, the company projects its financial resources will support operations into 2027. The total anticipated DANYELZA® net product revenues for the full year 2024 are between $95 million and $100 million, with operating expenses expected to be between $115 million and $120 million.
Clinical Trials and Regulatory Approvals
Y-mAbs Therapeutics is actively conducting clinical trials for several of its products, having received FDA breakthrough therapy designation for some. The company’s Named Patient Program (NPP) for DANYELZA® in Europe demonstrates its efforts towards global accessibility of its therapies. Y-mAbs' SADA technology platform is being developed for diverse tumor targets, intending to deliver various payloads for targeted cancer treatment.