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. 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, OMBLASTYS® (omburtamab), which targets tumors that express B7-H3. 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.
#Adium pharma s.a full#
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.
#Adium pharma s.a verification#
Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. This indication was approved by the US Food and Drug Administration (“FDA”) under accelerated approval based on overall response rate and duration of response. 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. MSK has institutional financial interests related to the compound and Y-mAbs. Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. We continue to focus on expansion of DANYELZA in other jurisdictions, working to provide access to children living with refractory or relapsed neuroblastoma,” said Thomas Gad, founder, President and Interim CEO. It’s very exciting to see this treatment approved, creating access to DANYELZA in Brazil from the joint efforts by our partner Adium and the development team at Y-mAbs.
“Today is an important day for children living with refractory/relapsed high-risk neuroblastoma in Brazil. DANYELZA is administered to patients three times in a week and the treatment is repeated every four weeks. (“Adium”).ĭANYELZA is a recombinant humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas.
DANYELZA will be marketed in Brazil by Y-mAbs’ partner Adium Pharma S.A. (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 the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (“Anvisa”) has granted marketing authorization for DANYELZA (naxitamab-gqgk) 40mg/10mL injection. NEW YORK, (GLOBE NEWSWIRE) - Y-mAbs Therapeutics, Inc.
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