Press Releases

Press Releases

Y-mAbs to Host Key Opinion Leader Webinar on DANYELZA® (naxitamab-gqgk) Frontline and HITS Data in High-Risk Neuroblastoma

Sep 10, 2021

NEW YORK, Sept. 10, 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 key opinion leader ("KOL") webinar on DANYELZA frontline and HITS data in high-risk neuroblastoma on Thursday, September 23, 2021 at 12 p.m. ET.

This webinar will feature presentations from KOLs Jaume Mora, M.D., Ph.D., SJD Barcelona Children's Hospital, and Shakeel Modak, M.D., MRCP, Memorial Sloan Kettering. Additionally, Thomas Gad, Chairman, Founder, and President at Y-mAbs, will provide a brief introduction followed by presentations from Steen Lisby, M.D., DMSc, SVP, Chief Scientific Officer at Y-mAbs, and Claus J. Moller San-Pedro, M.D., Ph.D., Chief Executive Officer at Y-mAbs.

  • Dr. Mora will present frontline data for DANYELZA in High-Risk Neuroblastoma
  • Dr. Modak will present HITS data for DANYELZA in High-Risk Neuroblastoma
  • Dr. Lisby will review Y-mAbs’ preclinical and research pipeline including its SADA technology
  • Dr. Moller will provide a corporate update

Thomas Gad as well as Drs. Modak, Mora, Lisby, and Moller will be available for questions following the presentations.

To register for the event, please click here.

Shakeel Modak, M.D., MRCP is a pediatric hematology-oncology doctor at Memorial Sloan Kettering Cancer Center, Department of Pediatrics in New York. He received his MBBS and M.D. degrees from TN Medical College, Bombay, as well as his MRCP degree from Royal College of Physicians, London. Dr. Modak specializes in the treatment of children and young adults with neuroblastoma and other solid tumors, such as DSRCT. He has been named to Best Doctors, New York City by Castle Connolly for the past six years in a row and in 2014. Dr. Modak has been the principal investigator on more than 12 studies in neuroblastoma and DSRCT. He has also been the co-investigator on over 50 trial protocols.

Jaume Mora, M.D., Ph.D. is the scientific director of the Oncology and Hematology area at SJD Barcelona Children's Hospital, as well as the director of the Developmental Tumors Laboratory at SJD Barcelona Children's Hospital. Dr. Mora is a member of several; national and international scientific societies, including the International Pediatric Oncology Society, which has awarded him the Schweisguth Prize, and the American Society of Clinical Oncology ("ASCO"), which honored him with the young investigator award ("YIA") in 2000, as well as the Career Development Award ("CDA"). In 2011, Dr. Mora was the recipient of the annual BBVA Foundation Award and, in 2006, of the First Prize of the Spanish Association Against Cancer ("AECC") award for the study of childhood cancer.

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 one 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 by the FDA 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, 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: 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 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 for the year ended December 31, 2020, 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.


Y-mAbs Therapeutics, Inc.
230 Park Avenue, Suite 3350
New York, NY 10169

+1 646 885 8505

E-mail: [email protected]

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Source: Y-mAbs Therapeutics, Inc