Adium

Y-mAbs Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, February 29, 2024
Acquisition, Research, Reiterate, Neoplasm, FDA, Cancer, Adium, Disassembler, International Society, NASDAQ Biotechnology Index, Interim, GM-CSF, Self-assembly, NBI, Therapy, Interest, Patient, HITS, Clinical trial, Congress, IND, Human, Cryptocurrency

On October 18, 2023, Y-mAbs announced that its Board of Directors appointed radiopharmaceutical industry veteran Mr. Rossi as President and Chief Executive Officer, effective November 6, 2023.

Key Points: 
  • On October 18, 2023, Y-mAbs announced that its Board of Directors appointed radiopharmaceutical industry veteran Mr. Rossi as President and Chief Executive Officer, effective November 6, 2023.
  • The DANYELZA net product revenues of $23.4 million in the fourth quarter of 2023, represented a favorable 17% increase compared to the third quarter of 2023, primarily driven by increased U.S. sales.
  • The Company did not have license revenues in the quarter ended December 31, 2023 and had license revenues of $0.5 million for the year ended December 31, 2023.
  • The net income for the quarter ended December 31, 2022, was after $15.0 million of license revenue recognized in the fourth quarter of 2022.

Y-mAbs Reports Third Quarter 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Monday, November 13, 2023
International Society, Acquisition, Research, Cancer, Therapy, Interim, IND, Traction, Net, Patient, Investigational New Drug, HITS, COFEPRIS, Growth, Congress, GM-CSF, Adium, Physician, Radioimmunotherapy, Cryptocurrency, Pharmaceutical industry, Video game, Rare-earth element, Temozolomide, Irinotecan

During the third quarter ended September 30, 2023, approximately 63% of the vials sold in the U.S. were sold outside of Memorial Sloan Kettering Cancer Center (“MSK”), compared to 61% in the second quarter ended June 30, 2023.

Key Points: 
  • During the third quarter ended September 30, 2023, approximately 63% of the vials sold in the U.S. were sold outside of Memorial Sloan Kettering Cancer Center (“MSK”), compared to 61% in the second quarter ended June 30, 2023.
  • Cost of goods sold was $2.6 million and $2.5 million for the third quarter ended September 30, 2023 and 2022, respectively.
  • Research and development expenses were $15.4 million for the third quarter ended September 30, 2023, a reduction of 32% compared to $22.5 million for the third quarter ended September 30, 2022.
  • Selling, general, and administrative expenses were $10.2 million for the third quarter ended September 30, 2023, a reduction of 25% compared to $13.6 million for the third quarter ended September 30, 2022.

Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the Treatment of High-Risk Neuroblastoma approved in Brazil

Retrieved on: 
Tuesday, May 23, 2023
Neuroblastoma, Interim, Adium, Sarcoma, Cancer, Patient, GD2, Memorial Sloan Kettering Cancer Center, MSK, Brazilian Health Regulatory Agency, Therapy, Pharmaceutical industry, Vaccine

DANYELZA will be marketed in Brazil by Y-mAbs’ partner Adium Pharma S.A. (“Adium”).

Key Points: 
  • DANYELZA will be marketed in Brazil by Y-mAbs’ partner Adium Pharma S.A. (“Adium”).
  • DANYELZA is administered to patients three times in a week and the treatment is repeated every four weeks.
  • “Today is an important day for children living with refractory/relapsed high-risk neuroblastoma in Brazil.
  • 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.

BeiGene Announces Brazil Approvals for BRUKINSA® As a Treatment for Rare Blood Cancers

Retrieved on: 
Thursday, November 10, 2022
Biotechnology, Medical Devices, Health, Health Technology, Oncology, Tislelizumab, Private Securities Litigation Reform Act, Bristol Myers Squibb, Marketing, Intellectual property, Adult, Mantle cell lymphoma, Research, PARP, Technology, SSE, Half-life, Adium, Global health, Urology, NASDAQ, Goal, Safety, U.S. Securities and Exchange Commission, Degenerative disease, BTK, Jazz Pharmaceuticals, Union, Pharmacokinetics, Company, Pharmacovigilance, Novartis, Patient, MCL, Therapy, Hematology, WM, Lymphoid leukemia, COVID-19, Pharmaceutical industry, Oncology, BeiGene

BRUKINSA was previously approved as a treatment in Brazil for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Key Points: 
  • BRUKINSA was previously approved as a treatment in Brazil for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
  • BeiGene is focused on developing innovative and affordable oncology medicines to improve treatment outcomes and access for patients worldwide.
  • These approvals demonstrate our commitment to accelerate development and broaden access to innovative medicines around the globe, said Alex Carvalho, Country General Manager, Brazil, at BeiGene.
  • BRUKINSA was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity.

BeiGene Expands Reach of its Innovative BTK Inhibitor with Recent Regulatory Approvals in Latin America

Retrieved on: 
Wednesday, October 26, 2022
Oncology, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, U.S. Securities and Exchange Commission, PARP, BTK, Therapy, CLL, Tislelizumab, Degenerative disease, Chronic lymphocytic leukemia, NASDAQ, Patient, Research, Twitter, Jazz Pharmaceuticals, Technology, Private Securities Litigation Reform Act, Goal, Pharmacovigilance, Company, Marketing, MCL, Novartis, Pharmacokinetics, SSE, Urology, Safety, Intellectual property, Department of Oncology, University of Cambridge, Bristol Myers Squibb, Lymphoid leukemia, COVID-19, Half-life, Global health, Pharmaceutical industry, Vaccine, Union, Oncology, Adium, Hematology, BeiGene

The announcement of regulatory approvals for BRUKINSA in Latin America follows a recent positive CHMP Opinion for BRUKINSA as a treatment for chronic lymphocytic leukemia (CLL) in the European Union.

Key Points: 
  • The announcement of regulatory approvals for BRUKINSA in Latin America follows a recent positive CHMP Opinion for BRUKINSA as a treatment for chronic lymphocytic leukemia (CLL) in the European Union.
  • BRUKINSA was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity.
  • BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs.
  • Adium provides its partners a full set of local capabilities including commercial, market access, regulatory and pharmacovigilance.

Y-mAbs Announces Regulatory Filing for DANYELZA® (naxitamab-gqgk) in Brazil

Retrieved on: 
Monday, September 26, 2022
Adult, Anaphylaxis, Risk, Cardiac arrest, Safety, COVID-19, Brazilian Health Regulatory Agency, FDA, Neoplasm, Neuropathic pain, Company, Growth, Neurotoxicity, Therapy, Industry, Government, Patient, Cancer, Interim, Adium, Bone marrow, Annual report, Memorial Sloan Kettering Cancer Center, Private Securities Litigation Reform Act, MSK, Â, NASDAQ, Research, GLOBE, Transverse myelitis, SEC, Marketing, Granulocyte-macrophage colony-stimulating factor, Failure, GD2, Pharmaceutical industry

We are very pleased with the regulatory capabilities of our partner Adium resulting in submission of DANYELZA for consideration of potential approval in Brazil.

Key Points: 
  • We are very pleased with the regulatory capabilities of our partner Adium resulting in submission of DANYELZA for consideration of potential approval 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.
  • 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.
  • Researchers at Memorial Sloan Kettering Cancer Center (MSK) developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs.

Y-mAbs Enters into Exclusive Distribution Agreement with Adium Pharma S.A. for DANYELZA® (naxitamab-gqgk) and Omburtamab in Latin America

Retrieved on: 
Wednesday, May 19, 2021
Instant messaging clients, Software, Clusters of differentiation, Immune system, CD276, Immune checkpoint, B7, Adium

B7-H3 is an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types.

Key Points: 
  • B7-H3 is an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types.
  • Under the terms of the agreement, Adium will employ its sales and marketing expertise to distribute DANYELZA and omburtamab, if approved, in the territory.
  • In addition, Adium will submit registration files on behalf of the Company in certain parts of the territory.
  • Adium distributes its products in 18 Latin American & Caribbean countries including Brazil, Mexico and Colombia.