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Y-mAbs Hosting Virtual Research and Development Day
المصدر: Nasdaq GlobeNewswire / 06 ديسمبر 2021 16:05:00 America/New_York
NEW YORK, Dec. 06, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that it will host a virtual research and development day on Wednesday, December 15, 2021 at 12pm Eastern Time.
The Y-mAbs research and development day will feature presentations from oncology key opinion leaders (“KOLs”) Javier E. Oesterheld, M.D. (Atrium Health) and Jaume Mora, M.D., Ph.D. (SJD Barcelona Children's Hospital).
Dr. Oesterheld will present on the current treatment landscape in the U.S. with DANYELZA® (naxitamab-gqgk); and Dr. Mora will present dosing experience with naxitamab for patients with pediatric high-risk neuroblastoma and other solid tumors from compassionate use.
An update on Y-mAbs Therapeutics’ broad and advanced product pipeline, including the SADA technology, will follow from Vignesh Rajah, MBBS, DCH, MRCP(UK) MBA, (SVP, Chief Medical Officer at Y-mAbs) and Steen Lisby, M.D., DMSc, (SVP, Chief Scientific Officer at Y-mAbs).
A question and answer session will follow the formal presentations. To register for the event, please click here.
Featured KOLs:
Jaume Mora, M.D., Ph.D. is the scientific director of Oncology and Hematology at SJD Barcelona Children's Hospital, as well as the director of its Developmental Tumours Laboratory. He is a member of several national and international scientific societies, including the International Pediatric Oncology Society, which awarded him the Schweisguth Prize, and the American Society of Clinical Oncology (ASCO), which in 2000 honored him with the young investigator award (YIA), as well as the Career Development Award (CDA). In 2011, Dr. Mora was the recipient of the annual BBVA Foundation Award and in 2006 he was awarded first prize of the Spanish Association Against Cancer (AECC) award for the study of child cancer.
Javier E. Oesterheld, M.D., is board certified in pediatric hematology-oncology and is helping to lead the ongoing pursuit of better treatments for childhood cancer. In 2017, he was named the first Jeff Gordon Children’s Foundation Endowment Chair - Levine Children’s Cancer and Blood Disorders Program, a role that supports his mission to improve lives and outcomes of pediatric cancer patients. He’s also the principal investigator for Carolinas Kids Cancer Research Coalition, in conjunction with the developmental therapeutics program at Levine Children’s Hospital. Additionally, Dr. Oesterheld is the study chair and/or site principal investigator for multiple clinical research studies into acute leukemia, refractory pediatric acute lymphoblastic leukemia, relapsed and refractory Neuroblastoma, and relapsed sarcomas. His research has been published in top journals and has led to numerous lecture invitations.
About DANYELZA® (naxitamab-gqgk)
DANYELZA® (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA® includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The Company has a broad and advanced product pipeline, including one FDA approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one pivotal-stage product candidate, omburtamab, which targets tumors that express B7-H3.
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about our business model and development, commercialization and product distribution plans; current and future clinical and pre-clinical studies and our research and development programs; expectations related to the timing of the initiation and completion of regulatory submissions; regulatory, marketing and reimbursement approvals; rate and degree of market acceptance and clinical utility as well as pricing and reimbursement levels; retaining and hiring key employees; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property position and strategy; additional product candidates and technologies; collaborations or strategic partnerships and the potential benefits thereof; expectations related to the use of our cash and cash equivalents, and the need for, timing and amount of any future financing transaction; our financial performance, including our estimates regarding revenues, expenses, capital expenditure requirements; developments relating to our competitors and our industry; and other statements that are not historical facts. Words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “hope,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: the risk that we may not close the transaction for the sale of our PRV voucher and would not have the additional funds provided by such sale to reinvest into our research and development programs; risks associated with our financial condition and need for additional capital; risks associated with our development work; cost and success of our product development activities and clinical trials; the risks of delay in the timing of our regulatory submissions or failure to receive approval of our drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of our product candidates; development of our sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for our products; the risks related to our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; the risks related to government regulation; risks related to market approval, risks associated with protection of our intellectual property rights; risks related to employee matters and managing growth; risks related to our common stock, risks associated with the pandemic caused by the novel coronavirus known as COVID-19 and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in our Annual Report on Form 10-K and in our other SEC filings. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
“DANYELZA” and “Y-mAbs” are registered trademarks of Y-mAbs Therapeutics, Inc.
Contact:
Y-mAbs Therapeutics, Inc.
230 Park Avenue, Suite 3350
New York, NY 10169
USA+1 646 885 8505
E-mail: info@ymabs.com