Welcome to our dedicated page for Y-Mabs Therapeutics news (Ticker: YMAB), a resource for investors and traders seeking the latest updates and insights on Y-Mabs Therapeutics stock.
Overview
Y-mAbs Therapeutics is a commercial-stage biopharmaceutical company focused on developing and commercializing antibody-based therapies and innovative radioimmunotherapy platforms for the treatment of cancer. With a mission centered on addressing unmet needs in oncology, particularly in the treatment of high-risk and pediatric cancers, the company leverages cutting-edge science to improve patient outcomes.
Core Technologies and Therapeutic Areas
The company’s portfolio exemplifies advanced therapeutic innovation in the biopharmaceutical sector. Its flagship product, DANYELZA, an FDA-approved therapy, targets ganglioside GD2, a biomarker expressed in various neuroectoderm-derived tumors and sarcomas. In addition to DANYELZA, Y-mAbs is actively developing novel product candidates such as naxitamab and omburtamab, which target specific tumor antigens and address relapsed or refractory indications in high-risk neuroblastoma and beyond.
Innovative Platforms and Research Initiatives
The company enhances its therapeutic potential through its proprietary Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy (PRIT) platform, which is designed to deliver targeted radiopharmaceutical treatments with precision. Complemented by the Y-BiClone platform for generating bispecific antibodies, these technologies exemplify the company’s commitment to transformative cancer treatments. The innovative approaches allow for the combination of antibody specificity with advanced radiotherapy methods, positioning Y-mAbs as a significant player in the field of immuno-oncology.
Commercial and Pipeline Strategy
Y-mAbs Therapeutics operates at the commercial stage with a proven record of introducing its products into specialty clinical markets. The commercialization of DANYELZA across multiple centers underscores its commitment to expanding access to targeted cancer therapies. Alongside commercial operations, the company sustains a robust pipeline of product candidates in various stages of clinical development, with pivotal studies designed to validate extended treatment protocols and improved response rates. This dual focus on current product success and future therapeutic innovation enhances its role in addressing oncological challenges.
Market Position and Competitive Edge
Within a competitive landscape characterized by rapid scientific advancements, Y-mAbs distinguishes itself not merely by its portfolio but through its technological differentiation and expertise in the field. By integrating targeted antibody-based mechanisms with radioimmunotherapy, the company provides an alternative therapeutic approach that complements existing treatment modalities in oncology. Its data-driven strategies in clinical development and commercialization continue to solidify its reputation among stakeholders and healthcare providers.
Clinical Impact and Scientific Rationale
Clinical studies and independent analyses lend authority to the company’s methodical approach towards prolonging patient survival and enhancing treatment tolerability. The ability of extended treatment cycles with agents like naxitamab to yield further clinical improvements underscores the scientific rationale behind sustained therapeutic engagement. These insights not only illustrate the complex interplay between dosage, response, and safety but also reinforce the commitment to evidence-based innovation in cancer treatment.
Strategic Collaborations and Future Readiness
Y-mAbs actively partners with academic institutions and global distribution channels to bolster its market presence and clinical outreach. The company’s licensing arrangements and collaborative initiatives with esteemed research centers fortify its scientific credibility and widen the impact of its therapeutic innovations. Such collaborations ensure a continual evolution of its therapeutic pipeline while maintaining stringent standards of efficacy and safety.
Conclusion
Overall, Y-mAbs Therapeutics stands as a prominent entity in the evolving biopharmaceutical arena. Its dedication to pioneering antibody-based and radioimmunotherapy solutions reflects a comprehensive strategy that interweaves clinical expertise, technological innovation, and strategic partnerships. This integrated approach not only addresses the existing challenges in cancer treatment but also sets a foundation for ongoing advancements in immuno-oncology.
Y-mAbs Therapeutics (YMAB) reported Q4 2024 financial results with total revenues of $26.5 million, up 13% year-over-year, and full-year 2024 revenues of $87.7 million, a 3% increase from 2023.
Key highlights include:
- U.S. DANYELZA revenues declined 12% in Q4 and 3% for full-year 2024
- International DANYELZA revenues grew 78% in Q4 and 16% for full-year 2024
- Cash position of $67.2 million as of December 31, 2024
- Net loss of $6.8 million in Q4 2024 ($0.15 per share)
The company established two business units in January 2025 for Radiopharmaceuticals Platform and DANYELZA commercialization. 2025 guidance projects total revenues between $75-90 million and operating expenses between $116-121 million. Cash runway expected into 2027.
Y-mAbs Therapeutics (YMAB) has published interim results from a Phase 2 clinical trial of naxitamab with GM-CSF in Nature Communications. The trial evaluated patients with relapsed/refractory high-risk neuroblastoma and residual disease in bone/bone marrow.
Key findings include:
- Overall response rate (ORR) of 50% (95% CI: 36-64%, N=52)
- Complete response in 38% and partial response in 12% of patients
- Bone compartment response of 58% (29/50)
- Bone marrow compartment response of 74% (17/23)
- One-year overall survival of 93% and progression-free survival of 35%
The treatment showed manageable safety with primarily infusion-related adverse events (90%), including hypotension and bronchospasm. The study met its primary endpoint with the ORR's lower confidence interval exceeding 20%.
Y-mAbs Therapeutics (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on developing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment, has announced it will release its fourth quarter and full year 2024 financial results before market open on Tuesday, March 4, 2025.
The company will host a conference call and webcast to discuss the results on March 4, 2025, at 8:00 a.m. ET. Interested parties can register for the live conference call, and a webcast will be available on the company's Investor Relations website, remaining accessible for at least 30 days afterward.
Y-mAbs Therapeutics (Nasdaq: YMAB), a commercial-stage biopharmaceutical company specializing in radioimmunotherapy and antibody-based therapeutic products for cancer treatment, has announced its participation in the Oppenheimer 35th Annual Life Sciences Conference.
The company's President and CEO, Michael Rossi, will engage in a fireside chat scheduled for Tuesday, February 11, 2025, at 4:40 p.m. ET. Investors and interested parties can access a live webcast of the presentation through the Events section on Y-mAbs' investor relations website at ir.ymabs.com. The presentation recording will remain available for replay on the website for 30 days following the event.
Y-mAbs Therapeutics (YMAB) presented preclinical and translational pharmacokinetics data of GD2-SADA at the SNMMI Mid-Winter and ACNM Annual Meeting in Anaheim. The presentation focused on plasma levels of GD2-SADA in animal models across various doses and time periods, along with concentration-dependent equilibrium between GD2-SADA tetramers and monomers in vitro.
The research has provided important insights into GD2-SADA tumor exposure and plasma elimination, which are key parameters for minimizing systemic exposure to 177Lutetium-DOTA. According to Norman LaFrance, Chief Development Officer, the human PK model of GD2-SADA has informed the design and initial dosing regimen of their ongoing first-in-human Phase 1 Trial (Trial 1001).
The SADA technology for radioimmunotherapy was developed at Memorial Sloan Kettering Cancer Center and is exclusively licensed to Y-mAbs.
Y-mAbs Therapeutics (NASDAQ: YMAB) announced strategic updates and 2025 priorities, establishing two business units: Radiopharmaceuticals and DANYELZA. The company reported preliminary unaudited total net revenue of approximately $88 million for 2024, within guidance, and cash position of $67 million as of December 31, 2024, expected to support operations into 2027.
The company's GD2-SADA Phase 1 trial has dosed 21 patients across six sites, with preliminary data showing good tolerability and no dose-limiting toxicities. Y-mAbs plans to present Part A data in Q2 2025. The business restructuring includes a workforce reduction of up to 13% and relocation of some roles from Denmark to the US to optimize radiopharmaceutical platform advancement.
The company expects to dose its first patient in the CD38-SADA Phase 1 trial in Q1 2025 and anticipates potential marketing approval for DANYELZA in new ex-US markets in 2025.
Y-mAbs Therapeutics (Nasdaq: YMAB) has appointed Doug Gentilcore as Senior Vice President, Head of DANYELZA Business Unit. This appointment comes as part of the company's strategy to expand the commercial potential of DANYELZA beyond pediatric oncology. Gentilcore brings over 20 years of pharmaceutical industry experience, previously serving as CEO of ARTMS, Inc. and founding Implerem, His background includes leadership roles at Jubilant Radiopharma, General Electric Healthcare Division, and Pfizer Pharmaceuticals.
The appointment coincides with the departure of Chief Commercial Officer Sue Smith, who led the U.S. Commercial team and DANYELZA relaunch. The company believes Gentilcore's extensive experience in pharmaceutical commercialization and global operations will be important for DANYELZA's growth strategy.
Y-mAbs Therapeutics (YMAB) announces strategic reorganization into two business units: Radiopharmaceuticals and DANYELZA. The company reports preliminary unaudited total net revenue of approximately $88 million for 2024, within guidance, and cash position of $67 million as of December 31, 2024, expected to support operations into 2027.
The company's GD2-SADA Phase 1 trial has dosed 21 patients across six sites, showing promising tolerability with no dose-limiting toxicities. Part A data presentation is expected in Q2 2025. The reorganization includes a workforce reduction of up to 13% and relocation of some roles from Denmark to the U.S.
Key 2025 milestones include presenting GD2-SADA optimization data, dosing the first patient in CD38-SADA Phase 1 trial in Q1, and potential DANYELZA marketing approval in new ex-U.S. markets.
Y-mAbs Therapeutics (Nasdaq: YMAB), a commercial-stage biopharmaceutical company specializing in radioimmunotherapy and antibody-based cancer treatments, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Michael Rossi, President and CEO, will deliver a presentation on January 15, 2025, at 5:15 p.m. PT in San Francisco.
The presentation will be accessible via live webcast through the Events section of Y-mAbs' investor relations website at ir.ymabs.com. The recording will remain available for replay for 30 days following the event.
Y-mAbs Therapeutics (NASDAQ: YMAB) presented preclinical data and trial progress for its CD38-SADA platform at the 2024 ASH Annual Meeting. The preclinical data demonstrated selective binding and anti-tumor efficacy of CD38-SADA when used with Lutetium 177-DOTA in treating Non-Hodgkin Lymphoma (NHL).
The company also presented details of its ongoing Phase 1 Trial 1201, evaluating CD38-SADA PRIT with Lu177-DOTA in adults with relapsed or refractory NHL. The trial consists of two parts: Part A focuses on dose escalation of CD38-SADA protein, while Part B aims to establish the optimal therapeutic dose of Lu177-DOTA. Both parts follow a 3+3 trial design with 4 planned dose levels.
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