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, 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.
Y-mAbs Therapeutics (Nasdaq: YMAB) will report its financial results for the quarter ending September 30, 2021, on November 4, 2021. A conference call is scheduled for November 5, 2021, at 9 a.m. ET, featuring key executives including Thomas Gad and Dr. Claus Moller. Y-mAbs focuses on developing antibody-based therapies for cancer treatment, with an FDA-approved product, DANYELZA®, and a pivotal-stage candidate, omburtamab. The company emphasizes its commitment to advancing its product pipeline during the upcoming financial disclosure.
FAQ
What is the current stock price of Y-mAbs Therapeutics (YMAB)?
What is the market cap of Y-mAbs Therapeutics (YMAB)?
What is Y-mAbs Therapeutics, Inc.?
What products does Y-mAbs offer?
What are Y-mAbs' key technologies?
What recent financial results has Y-mAbs reported?
How many centers are using DANYELZA?
What is Y-mAbs' mission?
Who are Y-mAbs' notable collaborators?
What is the SADA PRIT platform?
How is Y-mAbs financially positioned?
What future developments are expected from Y-mAbs?
