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 announced it will report its financial results for Q1 2022 on May 9, 2022, after U.S. market close. A conference call is scheduled for May 10, 2022, at 9 a.m. ET with executives including Thomas Gad, Bo Kruse, and Sue Smith. The company is involved in developing antibody-based cancer therapies, with one FDA-approved product, DANYELZA®, and another candidate, omburtamab, in the registration stage. For more information, investors can join the conference call using specific access numbers and a provided webcast link.
Y-mAbs Therapeutics announces significant management changes, with Dr. Claus Moller stepping down as CEO and Board Member. Thomas Gad, the Founder and Chairman, assumes the role of Interim CEO while Dr. Jim Healy is appointed as Chairman. The company reported first-quarter 2022 revenues of $10.5 million, a 9% increase sequentially, and provided revenue guidance of $45-$50 million for the year. As of March 31, 2022, Y-mAbs has $156.7 million in cash, ensuring funding until mid-2024, amidst ongoing regulatory review of their product omburtamab.
Y-mAbs Therapeutics (Nasdaq: YMAB) announced a poster presentation at the AACR Annual Meeting 2022 in New Orleans, showcasing preclinical data on its GD2 SADA construct. The SADA technology, licensed from Memorial Sloan Kettering and MIT, enhances tumor antigen binding and anti-tumor responses. Y-mAbs is focused on antibody-based cancer therapies and has one FDA-approved product, DANYELZA, aimed at GD2-expressing tumors, and another candidate, omburtamab, targeting B7-H3-expressing tumors.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) has resubmitted its Biologics License Application (BLA) for 131I-omburtamab to the FDA as of March 31, 2022. This investigational monoclonal antibody targets B7-H3 in pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The submission is informed by pivotal Phase 2 study results, expected to be published later this year. Y-mAbs aims to meet a critical medical need, as there are currently no effective treatments beyond surgery and radiotherapy for these patients.
Y-mAbs Therapeutics, Inc. (YMAB) announced significant business updates in its recent press release. The company completed a pre-BLA meeting with the FDA and plans to resubmit the BLA for omburtamab by Q1 2022. DANYELZA revenue reached $32.9 million in its first year, reflecting successful market adoption. Y-mAbs reported $34.9 million in net revenue for 2021, with a gross margin of 93%. However, the company incurred a net loss of $55.3 million for the year. Y-mAbs maintains a solid cash position of $181.6 million, ensuring operational runway through 2023.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) will report its financial results for the year ending December 31, 2021, on February 24, 2022, after market close. Following this, a conference call will occur on February 25, 2022, at 9 a.m. ET featuring key executives including Thomas Gad and Dr. Claus Moller. Y-mAbs focuses on antibody-based cancer treatments, with FDA-approved DANYELZA® and its registration-stage candidate omburtamab targeting specific tumor markers. The company utilizes advanced platforms for its product pipeline.
Y-mAbs Therapeutics (YMAB) announced a successful pre-BLA meeting with the FDA for omburtamab, aimed at treating CNS/leptomeningeal metastases from neuroblastoma. The company plans to resubmit the Biologics License Application by Q1 2022. A study at Memorial Sloan Kettering showed patients had a median survival of 50 months, with complete clinical data to be included in the BLA. Y-mAbs emphasizes the drug's potential to fulfill a critical medical need in pediatric oncology.
Y-mAbs Therapeutics (Nasdaq: YMAB) announced that CEO Dr. Claus Moller will present an overview of the company's business at the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022, at 9:00 AM EST. The presentation will be available via a live audio webcast. Y-mAbs focuses on developing antibody-based therapeutics for cancer treatment, including the FDA-approved DANYELZA®.
Y-mAbs Therapeutics (Nasdaq: YMAB) has announced a virtual R&D event to showcase clinical experiences with naxitamab and updates on their SADA technology. Notable presentations will include Dr. Jaume Mora discussing new infusion protocols for naxitamab, potentially improving safety for patients. The company also plans to file an Investigational New Drug Application for GD2-SADA by year-end. CEO Claus Moller expressed optimism about the potential of SADA to revolutionize cancer treatments.
Y-mAbs Therapeutics (Nasdaq: YMAB) recently held a virtual R&D event, presenting significant updates on its SADA technology and the clinical use of naxitamab. Highlights include plans to file an Investigational New Drug Application for GD2-SADA by year-end and new compassionate use data for naxitamab, demonstrating potential to manage severe adverse events. Key opinion leaders discussed advancements in treating GD2-positive indications, expanding naxitamab's potential applications. The company also expressed optimism about the commercialization of its innovative therapeutic products in the oncology landscape.
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