News

  • 1 August 2019

    Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing a novel implantable Sacral Neuromodulation (“SNM”) device for the treatment of urinary and bowel dysfunction, today announced completion of 1-year follow-ups and top-line clinical results from its ARTISAN-SNM pivotal clinical study conducted under an U.S. Food & Drug Administration (“FDA”) Investigational Device Exemption (“IDE”) designed to evaluate the safety and efficacy of the Axonics r-SNM® System.

  • 30 July 2019

    X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of rare diseases, today announced that the European Commission (EC), based on a favorable recommendation from the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP), has granted orphan drug designation (ODD) to mavorixafor (X4P-001) for the treatment of WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. In October 2018, mavorixafor was granted ODD for the treatment of WHIM syndrome by the U.S. Food and Drug Administration. The exact prevalence of WHIM syndrome is unknown, however, in the United Statesalone there are between 15,000 and 100,000 patients classified as having a primary immunodeficiency disease of unknown origin – of which WHIM syndrome is one.

  • 29 July 2019

    Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, today announced the results from its ARTISAN-SNM study were published online in the peer-reviewed Journal of Urology (https://doi.org/10.1097/JU.0000000000000458).

  • 25 July 2019

    Genkyotex (Euronext Paris & Brussels: FR0013399474 – GKTX), a biopharmaceutical company and the leader in NOX therapies, announced today positive post-hoc analysis of PBC phase 2 trial. 

  • 22 July 2019

    Genkyotex (Euronext Paris & Brussels: FR0013399474 – GKTX) a biopharmaceutical company and the leader in NOX therapies, today announced that the World Health Organization (WHO) has recommended setanaxib as the international nonproprietary name (INN) for GKT831.