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 (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.
Y-mAbs Therapeutics announced that the FDA granted Rare Pediatric Disease Designation for its 177Lu-omburtamab-DTPA antibody program aimed at treating medulloblastoma. This designation allows eligibility for a Priority Review Voucher upon potential approval of the biologics license application. The company is advancing this program through Phase 1 clinical trials for both pediatric and adult patients with B7-H3 positive tumors. Y-mAbs now has four compounds with RPDD, highlighting its commitment to addressing unmet medical needs in rare pediatric cancers.
Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) announced the acceptance of two presentations at the International Society of Pediatric Oncology Virtual Annual Congress from October 21-24, 2021. The oral presentation will focus on DANYELZA® for treating high-risk neuroblastoma, while a poster will detail omburtamab for CNS metastasis treatment. Both products are licensed from Memorial Sloan Kettering. DANYELZA is approved for pediatric patients and carries a Boxed Warning for serious side effects. Y-mAbs is advancing its pipeline targeting GD2 and B7-H3 tumor-associated markers.
Y-mAbs Therapeutics announced that its partner SciClone Pharmaceuticals received priority review for the Biologics License Application (BLA) of DANYELZA® (naxitamab-gqgk) for treating high-risk neuroblastoma in China. This priority review aims to expedite the approval process, with potential launch expected by Q1 2022. DANYELZA was recently administered to its first patient in China, marking a significant milestone for the company.
Y-mAbs Therapeutics announced a key opinion leader webinar on DANYELZA data for high-risk neuroblastoma on September 23, 2021. The event will feature experts Jaume Mora and Shakeel Modak presenting frontline and HITS data, respectively. Company leaders Thomas Gad, Steen Lisby, and Claus J. Moller will offer updates on the pipeline and corporate strategy. DANYELZA is FDA-approved for treating high-risk neuroblastoma in pediatric and adult patients. Registration is available here.
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