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) has announced a registered underwritten public offering of up to $100 million in shares of its common stock, with a potential additional purchase option of $15 million for the underwriters. The offering will be managed by J.P. Morgan, Morgan Stanley, and BofA Securities, and is subject to market conditions. A shelf registration statement for the shares has been effective since October 15, 2019. Y-mAbs focuses on developing antibody-based therapies for cancer, including its FDA-approved product, DANYELZA®.
Y-mAbs Therapeutics (Nasdaq: YMAB) will present an overview of its business at the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021, at 10:00 AM EST. The presentation, led by CEO Dr. Claus Møller, will be accessible via a live webcast. Y-mAbs focuses on developing antibody-based therapies for cancer, featuring an extensive pipeline, including the FDA-approved product DANYELZA® for GD2-expressing tumors and omburtamab, a pivotal-stage candidate targeting B7-H3 tumors.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) has agreed to sell its Priority Review Voucher (PRV) to United Therapeutics Corporation for $105 million. The PRV was awarded alongside the FDA approval of DANYELZA® for treating high-risk neuroblastoma. Y-mAbs will retain 60% of the proceeds, with the remaining 40% going to Memorial Sloan Kettering Cancer Center. This non-dilutive capital is crucial for funding additional research and development. The transaction is subject to customary closing conditions, including anti-trust review.
Y-mAbs Therapeutics (YMAB) has signed a license agreement with SciClone Pharmaceuticals for the co-development and commercialization of its antibodies, DANYELZA® and omburtamab, in Greater China. DANYELZA, FDA approved for treating high-risk neuroblastoma, will now leverage SciClone's expertise in the region. Y-mAbs will receive a $20 million upfront payment, with potential additional milestone payments totaling up to $100 million, plus royalties on sales. The partnership aims to address unmet medical needs in pediatric cancer treatment in China.
Y-mAbs Therapeutics (NASDAQ: YMAB) has signed a distribution agreement with Swixx BioPharma AG to exclusively distribute its antibody DANYELZA® in Eastern Europe, including Russia. DANYELZA, approved by the FDA on Nov 25, 2020, is used for treating relapsed/refractory high-risk neuroblastoma. The agreement covers several countries and allows Swixx to submit registration files on Y-mAbs’ behalf. The company plans to resubmit its Biologics License Application for omburtamab by early 2021. Financial terms of the deal were not disclosed.
Y-mAbs Therapeutics announced a virtual R&D event on December 16, 2020, to present data on DANYELZA, omburtamab, and nivatrotamab. Key opinion leaders discussed advancements in treating high-risk neuroblastoma and osteosarcoma. Notably, DANYELZA showed a 74.3% event-free survival rate at 24 months in first complete remission patients. The company confirmed plans to resubmit omburtamab's BLA to the FDA in early 2021, showcasing supportive survival data. However, initial results for nivatrotamab were less favorable, lacking complete or partial responses.
Y-mAbs Therapeutics (YMAB) announced a compelling clinical update on DANYELZA® (naxitamab-gqgk) for refractory/relapsed high-risk neuroblastoma at the ESMO Immuno-Oncology Virtual Congress 2020. Study 201 showed an overall response rate (ORR) of 68%, with 59% complete responses. The treatment was primarily outpatient, demonstrating a 98% adherence rate and median infusion time of 37 minutes. DANYELZA, recently approved by the FDA, indicates significant potential in addressing unmet medical needs among difficult-to-treat patients.
Y-mAbs Therapeutics (Nasdaq: YMAB) will host a virtual R&D day on December 16, 2020, from 12 PM to 2 PM ET. Key Opinion Leaders, including Dr. Shakeel Modak from Memorial Sloan Kettering, will present topics on DANYELZA® (naxitamab-gqgk) and its combination with chemotherapy, along with updates on other studies related to osteosarcoma and DIPG. Management will detail advancements regarding their bispecific antibody, nivatrotamab, and additional products. Participants can register for the event online.
Y-mAbs Therapeutics (Nasdaq: YMAB) has partnered with Takeda Israel to establish an exclusive license and distribution agreement for DANYELZA and omburtamab in Israel. DANYELZA, which received FDA approval on November 25, 2020, treats relapsed/refractory high-risk neuroblastoma. Meanwhile, Y-mAbs plans to resubmit the BLA for omburtamab by early 2021. This agreement will facilitate access to these critical treatments for pediatric patients in Israel and surrounding regions, addressing unmet medical needs.
Y-mAbs Therapeutics announced FDA approval for DANYELZA (naxitamab-gqgk) 40mg/10ml, indicated for treating high-risk neuroblastoma in patients aged one and older. DANYELZA, combined with granulocyte-macrophage colony-stimulating factor (GM-CSF), targets GD2, a ganglioside in neuroectoderm-derived tumors. This accelerated approval requires further clinical trials to confirm benefits. DANYELZA is expected in U.S. markets soon, supported by two pivotal studies showing manageable adverse events, enhancing Y-mAbs' oncology product pipeline.
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