Y-mAbs Therapeutics, Inc. - YMAB STOCK NEWS

Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) will announce its financial results for the fiscal year ended December 31, 2020, on February 25, 2021, after U.S. market close. A conference call and webcast will follow on February 26, 2021, at 9 a.m. ET, featuring company executives. Y-mAbs is focused on developing antibody-based cancer therapies, boasting one FDA-approved product, DANYELZA® (naxitamab-gqgk), and a pivotal-stage candidate, omburtamab. The press release includes forward-looking statements on business strategies and financial expectations, emphasizing the need for future funding.

Y-mAbs Therapeutics (Nasdaq: YMAB) announced a public offering of 2,439,025 shares at $41.00 each, expected to generate approximately $100 million in gross proceeds. All shares are offered by Y-mAbs, with an additional 365,853 shares available for underwriters to purchase within 30 days. The offering is set to close on February 22, 2021, pending customary conditions. J.P. Morgan, Morgan Stanley, and BofA Securities are the joint book-running managers. Proceeds will support Y-mAbs' advanced product pipeline for cancer therapies, including FDA-approved DANYELZA® and pivotal-stage omburtamab.

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.