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.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) is a commercial-stage biopharmaceutical company dedicated to the development and commercialization of novel, antibody-based therapeutic products for cancer treatment. The company focuses on addressing unmet medical needs, particularly in pediatric oncology, and aims to become a leader in this field.
The company's advanced product pipeline includes two pivotal-stage product candidates: naxitamab and omburtamab. Naxitamab targets tumors expressing GD2, while omburtamab targets those expressing B7-H3. Y-mAbs' flagship FDA-approved product, DANYELZA® (naxitamab-gqgk), is a recombinant humanized immunoglobulin G subtype 1k monoclonal antibody designed to treat relapsed or refractory high-risk neuroblastoma in bone or bone marrow.
Y-mAbs is also pioneering novel technologies such as the investigational Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy (PRIT) platform and bispecific antibodies generated via the Y-BiClone platform. These innovative approaches aim to deliver optimal cancer therapy with minimal toxicity, leveraging existing infrastructure and enhancing patient care.
Financially, Y-mAbs has shown robust performance with increasing revenues from DANYELZA. For the fourth quarter of 2023, the company reported DANYELZA net product revenues of $23.4 million, up 42% year-over-year. The annual revenue reached $84.3 million, marking a 71% increase over the previous year. As of December 31, 2023, the company has delivered DANYELZA to 58 centers across the U.S.
In the first quarter of 2024, Y-mAbs continued its upward trajectory with U.S. DANYELZA net product revenues amounting to $18.6 million. The company maintains a strong financial foundation with approximately $75.7 million in cash and cash equivalents as of March 31, 2024, expected to support operations into 2027.
Y-mAbs collaborates with renowned institutions like Memorial Sloan Kettering Cancer Center (MSK), with exclusive licenses for technologies developed by MSK researchers. This ongoing partnership enhances Y-mAbs' capabilities in advancing their innovative therapeutic platforms.
The company's mission is clear: to transform cancer treatment outcomes by providing better and safer therapies for both children and adults. With continued advancements and strategic partnerships, Y-mAbs remains at the forefront of biopharmaceutical innovation.
Y-mAbs Therapeutics has announced the appointment of Dr. Norman LaFrance as Chief Development Officer. Dr. LaFrance brings over 40 years of experience in radiopharmaceuticals, having previously served in senior roles at PLUS Therapeutics, Jubilant Pharma, and IBA Molecular. He is expected to advance Y-mAbs' novel SADA-PRIT technology platform aimed at treating cancer and other serious diseases. Dr. LaFrance holds degrees in nuclear engineering and science from Rensselaer Polytechnic Institute and an M.D. from the University of Arizona, with board certifications in internal medicine and nuclear medicine.
His extensive background includes significant roles in the development and commercialization of radiotherapeutics and molecular imaging products. Y-mAbs aims to leverage his expertise to further their mission of improving patient outcomes through innovative cancer treatments.
Y-mAbs Therapeutics, a commercial-stage biopharmaceutical company, announced the publication of preclinical data on GD2-SADA at the 2024 ASCO Annual Meeting. The study details the binding properties of GD2-SADA, a bispecific fusion protein, to GD2-expressing cell lines and its anti-tumor efficacy when paired with Lutetium 177 (Lu177)-DOTA in pretargeted radioimmunotherapy (PRIT). The GD2-SADA protein showed high-affinity binding to lanthanide metal-DOTA complexes and negligible binding to trace metal-DOTA complexes, supporting its potential for targeted cancer treatment. These promising results pave the way for further clinical development in treating GD2-positive tumors in adults and adolescents.
Y-mAbs Therapeutics announced interim Phase 2 data for naxitamab at the 2024 ASCO Annual Meeting. The data from Trial 201 show a 50% overall response rate (ORR) in patients with relapsed/refractory high-risk neuroblastoma. Continued naxitamab treatment led to further disease reduction, with 25% achieving complete or partial response after three or more cycles.
Adverse events (AEs) were mostly mild to moderate, with 81% being Grade 1 or 2. Grade ≥3 AEs included hypotension (60%), pain (58%), and others. Notably, the frequency of severe pain and hypotension decreased over treatment cycles.
An independent study from Sant Joan de Déu Barcelona presented data on naxitamab combined with alternative chemotherapies, showing manageable safety profiles and better responses with prior chemo-immunotherapy sensitivity.
Y-mAbs reported U.S. DANYELZA® net product revenues of $18.6 million, an 11% YoY increase, while Worldwide DANYELZA net product revenues were $19.4 million, a 4% YoY decrease. Cash and cash equivalents stood at $75.7 million with a cash burn of $2.9 million. The Company reiterates full year 2024 financial guidance. First quarter marked highest U.S. demand for DANYELZA® since launch, with significant clinical advancements. Distribution partner initiated commercial launch in Latin America, abstracts to be presented at ASCO Annual Meeting. Financially, total net product revenues decreased by 4% YoY, with U.S. revenues increasing by 11%. Operating expenses and cash burn were within guidance, supporting operations into 2027.
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