![]() Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts,constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. ![]() The Company’s broad and advanced product pipeline includes one FDA-approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one product candidate at the registration-stage, omburtamab, which targets tumors that express B7-3. In addition to conventional antibodies, the Company’s technologies include bispecific antibodies generated using the Y-BiClone platform and the SADA platform. Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic cancer products. See full Prescribing Information for complete Boxed Warning and other important safety information. 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. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. Federal Drug Administration based on overall response rate and duration of response. This indication was approved under accelerated approval by the U.S. In the United States, 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. As a result of this licensing arrangement, MSK has institutional financial interests in the compound. Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. “If approved by Anvisa, we look forward to working closely with Adium on the production and logistic planning for DANYELZA to help ensure timely availability to patients in Brazil.” We believe this submission marks another important milestone in our aim to make DANYELZA globally available and address an unmet medical need for families in Brazil,” said Thomas Gad, President, and Interim Chief Executive Officer. “We are very pleased with the regulatory capabilities of our partner Adium resulting in submission of DANYELZA® for consideration of potential approval in Brazil. (“Adium”) has submitted a regulatory filing for DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma to the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (“Anvisa”). (“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 Adium Pharma S.A. 26, 2022 (GLOBE NEWSWIRE) - Y-mAbs Therapeutics, Inc.
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