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. (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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