Y-mAbs Therapeutics
Clinical-stage biopharmaceutical company focused on development and commercialization of antibody-based therapies and radiopharmaceuticals for pediatric and adult oncology. Core activities include development of monoclonal antibody therapies, a modular pre-targeted radioimmunotherapy (SADA PRIT) platform, clinical trial execution, GMP/CMC process development, and partnerships for global expansion and investigator-sponsored research.
Industries
Nr. of Employees
medium (51-250)
Products
DANYELZA (naxitamab‑gqgk) 40 mg/10 mL injection
Commercially approved humanized monoclonal antibody targeting GD2 for certain oncology indications; prescribing information and boxed warnings available in product labeling.
SADA PRIT Technology Platform (investigational)
Self‑assembling/disassembling modular platform for pre-targeted radioimmunotherapy designed to enable high-avidity tumor targeting and rapid clearance of unbound components; intended for theranostic imaging and therapeutic payload delivery.
DANYELZA (naxitamab‑gqgk) 40 mg/10 mL injection
Commercially approved humanized monoclonal antibody targeting GD2 for certain oncology indications; prescribing information and boxed warnings available in product labeling.
SADA PRIT Technology Platform (investigational)
Self‑assembling/disassembling modular platform for pre-targeted radioimmunotherapy designed to enable high-avidity tumor targeting and rapid clearance of unbound components; intended for theranostic imaging and therapeutic payload delivery.
Services
Review and potential provision of product and/or funding for external investigator‑initiated clinical or preclinical studies aligned to company scientific priorities; submission portal and proposal review process.
Country-specific evaluation process to consider providing investigational medicine to individual patients when clinical trial enrollment is not an option.
Telephone and email channels for medical information requests and adverse event/product complaint reporting; drug safety contact points for regulatory reporting.
Partner identification and collaboration for global expansion of commercial products and co-development of SADA PRIT targets; licensing and BD contact channels.
Review and potential provision of product and/or funding for external investigator‑initiated clinical or preclinical studies aligned to company scientific priorities; submission portal and proposal review process.
Country-specific evaluation process to consider providing investigational medicine to individual patients when clinical trial enrollment is not an option.
Telephone and email channels for medical information requests and adverse event/product complaint reporting; drug safety contact points for regulatory reporting.
Partner identification and collaboration for global expansion of commercial products and co-development of SADA PRIT targets; licensing and BD contact channels.
Expertise Areas
- Radioimmunotherapy and radiopharmaceutical development
- Monoclonal antibody therapeutics
- Pediatric oncology drug development
- Clinical trial management and site enrollment
Key Technologies
- Pre-targeted radioimmunotherapy (SADA PRIT)
- Monoclonal antibody engineering
- Radiolabeling with therapeutic and diagnostic isotopes (e.g., 177Lu, 225Ac, 89Zr)
- Theranostic imaging for patient selection
News & Updates
The company lists its monoclonal antibody product as U.S. FDA approved in pipeline and product pages.
The company lists its monoclonal antibody product as U.S. FDA approved in pipeline and product pages.