NIJMEGEN, Netherlands, May 15, 2023 /PRNewswire/ -- Byondis B.V., an independent, Dutch clinical-stage biopharmaceutical company creating precision medicines, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biological License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985). With this BLA, Byondis sought approval for its anti-HER2 antibody-drug conjugate (ADC) in HER2-positive unresectable locally advanced or metastatic breast cancer (MBC), a disease with a high unmet medical need.
Byondis B.V., an independent, clinical stage Dutch biopharmaceutical company creating precision medicines, today announced that the first cancer...
Byondis B.V., an independent, Dutch clinical stage biopharmaceutical company creating precision medicines, announced today that the European...
Byondis B.V., an independent, Dutch clinical stage biopharmaceutical company creating precision medicines, announced today that the U.S. Food & Drug...
Byondis and Medac have announced that they will enter into a license and collaboration agreement to commercialise Byondis’ lead programme anti-HER2 antibody-drug conjugate (ADC), trastuzumab duocarmazine (also known as SYD985).
Byondis B.V., an independent, Dutch clinical stage biopharmaceutical company, has entered into a License and Collaboration Agreement and a Supply Agreement with medac GmbH, a privately owned pharmaceutical company based in Germany.
NIJMEGEN, Netherlands, Sept. 19, 2021 /PRNewswire/ -- At a late-breaking oral presentation (LBA15) at the virtual 2021 ESMO Congress today, Byondis B.V., an independent, clinical stage biopharmaceutical company creating precision medicines, reported positive results from its pivotal Phase III TULIP® study. The multi-center, open-label, randomized clinical trial compared the efficacy and safety of the company's antibody-drug conjugate (ADC) [vic-]trastuzumab duocarmazine (SYD985) to physician's choice (PC) treatment in patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).
Nijmegen, The Netherlands – 16 September 2021 – Byondis BV, an independent, clinical stage biopharmaceutical company creating precision medicines, announced that the results of the TULIP® study will be presented as a late-breaking oral presentation at the virtual ESMO 2021 Congress on 19 September.
Byondis B.V. today announced the appointment of Timo K. van den Berg, Ph.D., as senior director, Immuno-Oncology (IO) Research and Development. Van den Berg will assume this role on September 1, operating out of Byondis' headquarters in Nijmegen.
Byondis has revealed positive Phase III results for (ADC) [vic-]trastuzumab duocarmazine (SYD985) in patients with HER2-positive unresectable locally advanced or metastatic breast cancer.