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) generates news that spans commercial oncology performance, clinical development milestones in radioimmunotherapy, and significant corporate transactions. Company announcements consistently describe Y-mAbs as a commercial-stage biopharmaceutical company focused on novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, with its lead commercial asset DANYELZA® (naxitamab-gqgk) for relapsed or refractory high-risk neuroblastoma.
News coverage for Y-mAbs frequently highlights financial results and segment updates, including quarterly revenue from DANYELZA, ex-U.S. distribution trends, and the allocation of resources between the DANYELZA and Radiopharmaceuticals business units. Earnings releases often discuss cost of goods sold, research and development spending, selling, general, and administrative expenses, and net loss, along with management commentary on operating strategy and capital efficiency.
Another major category of YMAB news involves clinical and R&D developments in the company’s SADA Pretargeted Radioimmunotherapy (PRIT) platform. Press releases describe progress in the GD2-SADA Phase 1 Trial 1001 in GD2-expressing solid tumors, including pharmacokinetic and dosimetry data, and the initiation of the CD38-SADA Phase 1 Trial 1201 in relapsed or refractory non-Hodgkin lymphoma. Y-mAbs also reports on preclinical pharmacokinetic modeling, optimization of radiohaptens such as “Proteus,” and expansion of its radiopharmaceutical pipeline into additional oncology franchises.
Y-mAbs news also covers regulatory and guideline recognition, such as the inclusion of naxitamab-gqgk (DANYELZA) as a Category 2A treatment option in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Neuroblastoma. These updates provide context on how DANYELZA is positioned within clinical practice for high-risk neuroblastoma.
A key theme in recent YMAB headlines is corporate transformation and acquisition activity. In August 2025, Y-mAbs announced that SERB Pharmaceuticals, through an affiliate, agreed to acquire the company in an all-cash transaction at $8.60 per share, with an equity value of approximately $412 million, as described in joint press releases and Form 8-K filings. Subsequent news and SEC filings report the commencement and completion of the tender offer, the closing of the merger, and the resulting delisting of Y-mAbs common stock from the Nasdaq Global Select Market.
Investors and observers following YMAB-related news can expect updates on quarterly financial performance, DANYELZA commercial metrics, clinical trial progress for SADA-based programs, radiopharmaceutical R&D strategy, and the implications of the company’s acquisition by an affiliate of SERB Pharmaceuticals. This news flow provides insight into both the historical public-company phase of Y-mAbs and its transition into a privately held subsidiary within a larger specialty pharmaceutical group.
Y-mAbs Therapeutics announced it received a Refusal to File letter from the FDA for its Biologics License Application (BLA) of omburtamab, aimed at treating pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The FDA cited the need for additional details in the Chemistry, Manufacturing and Control module and the Clinical module of the BLA. Y-mAbs plans to address these concerns and resubmit the BLA by year-end 2020, following a Type A meeting with the FDA. An investor call is set for October 6, 2020, to discuss this update.
Y-mAbs Therapeutics reported its second quarter 2020 financial results, highlighting a net loss of $40.4 million, or $1.01 per share, compared to a loss of $18.0 million in Q2 2019. The company completed its omburtamab BLA submission and received FDA priority review for naxitamab. R&D expenses surged to $30.1 million due to increased milestones and personnel costs. General and administrative costs also rose to $10.4 million. As of June 30, 2020, Y-mAbs had $158.1 million in cash, down from $207.1 million at year-end 2019.
Y-mAbs Therapeutics (Nasdaq: YMAB) announced the submission of its Biologics License Application for omburtamab on August 5, 2020. This investigational monoclonal antibody targets B7-H3 to treat pediatric CNS/leptomeningeal metastasis from neuroblastoma. The submission is based on pivotal Phase 2 study results. The company aims to address an unmet medical need as no standard therapies are available for these patients. Y-mAbs has additional studies planned for omburtamab in other cancer types.
Y-mAbs Therapeutics (YMAB) announced acceptance of five oral presentations for its lead product naxitamab at the SIOP Virtual Annual Congress, scheduled for October 14-17, 2020. Naxitamab is under priority review by the FDA for relapsed/refractory high-risk neuroblastoma, with an action date of November 30, 2020. The company also reported on omburtamab and its GD2-GD3 vaccine candidates, indicating progress in clinical trials. Y-mAbs continues to focus on developing antibody-based therapies for pediatric cancers.
Y-mAbs Therapeutics (Nasdaq: YMAB) announced that Dr. Brian H. Santich will present an update on the SADA technology at the SNMMI Virtual Annual Meeting on July 14, 2020. SADA technology demonstrates effective 2-step payload delivery, showcasing tumor shrinkage without harming other tissues. Four targets are in pre-clinical development, including B7-H3 SADA for prostate cancer. The company plans to submit its first IND for a SADA construct in 2021, aiming to innovate cancer treatment with Liquid Radiation™.
Y-mAbs Therapeutics (YMAB) announced the initiation of its Biologics License Application for omburtamab under the FDA's Rolling Review process. This investigational monoclonal antibody targets B7-H3 in pediatric patients with CNS/leptomeningeal metastases from neuroblastoma. The non-clinical and part of the CMC portions of the BLA were submitted in June 2020, with completion expected in 4-6 weeks. Clinical submission will rely on pivotal Phase 2 studies 101 and 03-133. Omburtamab aims to address significant unmet medical needs for affected children, representing a key milestone for Y-mAbs.
Y-mAbs Therapeutics reported a net loss of $26.2 million for Q1 2020, an increase from $15.9 million in Q1 2019. R&D expenses rose to $18.6 million, reflecting increased costs for product development and manufacturing. General and administrative expenses also surged to $8.1 million. Y-mAbs successfully submitted its BLA for naxitamab and is progressing with the rolling BLA for omburtamab, expected to conclude in June 2020. The company entered an exclusive licensing agreement for SADA technology, potentially enhancing its therapeutic capabilities.
Summary not available.