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. (YMAB) is a commercial-stage biopharmaceutical leader pioneering antibody-based therapies and radioimmunotherapy for pediatric and adult cancers. This page provides investors and medical professionals with comprehensive access to Y-mAbs' official news, including FDA regulatory updates, clinical trial results, and strategic partnership announcements.
As the developer of DANYELZA – an FDA-approved treatment for high-risk neuroblastoma – Y-mAbs demonstrates ongoing innovation through its SADA PRIT platform and bispecific antibody research. Our curated news collection enables stakeholders to track the company's progress in advancing precision oncology treatments while maintaining compliance with rigorous clinical standards.
Key updates include press releases on product commercialization milestones, peer-reviewed study publications, and developments in the company's pipeline targeting GD2-expressing tumors. All content is sourced directly from Y-mAbs Therapeutics and verified financial disclosures to ensure reliability.
Bookmark this page for real-time updates on YMAB's scientific advancements and market-moving developments. Investors can leverage this resource to monitor the company's progress in bringing novel radioimmunotherapies through clinical trials to commercialization.
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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