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, 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.
Y-mAbs Therapeutics (Nasdaq: YMAB) announced a virtual research and development day on December 15, 2021, featuring key presentations from oncology leaders about the treatment landscape for DANYELZA® (naxitamab-gqgk) and its application in pediatric patients. Dr. Oesterheld will discuss the U.S. treatment landscape, while Dr. Mora will share dosing experiences for neuroblastoma patients. The event will also provide an update on Y-mAbs' product pipeline, including SADA technology. Attendees can register for the event through the company’s website.
Y-mAbs Therapeutics (Nasdaq: YMAB) reported its Q3 2021 financial results, highlighting a net loss of $28.9 million ($0.66 per share), down from $32.8 million ($0.82 per share) a year prior. DANYELZA sales surged by 49% quarter-over-quarter, totaling $9.0 million for Q3. The company anticipates submitting its omburtamab BLA resubmission soon after a pre-BLA meeting planned for January 2022. Cash reserves increased to $215.7 million due to a $62.0 million priority review voucher sale and a $107.7 million public offering. R&D expenses rose to $23.1 million, driven by clinical trials.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) has announced its request for a pre-BLA meeting with the FDA regarding omburtamab for treating pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The meeting is expected in January 2022, aiming for resubmission of the BLA shortly after. If successful, the FDA approval could occur by Q4 2022. The company, which has DANYELZA® approved, emphasizes the significant unmet medical need for the targeted treatment. The announcement follows a Type B meeting with the FDA.
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