GlobeNewswire Press

  1. Genkyotex Announces FDA Approval Of Phase 2 Investigator-Initiated Trial With GKT831 In IPF 7/17/2019

    Genkyotex (Euronext Paris & Brussels: FR0013399474 – GKTX) a biopharmaceutical company and the leader in NOX therapies, announced today that the United States Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application allowing the initiation of a Phase 2 trial of the Company’s lead product candidate, GKT831, in patients with idiopathic pulmonary fibrosis (IPF).

  2. AC Immune Initiates Phase 1 Study Of ACI-3024 Small Molecule Tau Morphomer™, An Investigational Treatment For Alzheimer's Disease 7/17/2019

    AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company, today announced dosing of the first subject in a Phase 1 study of ACI-3024, a first-in-class investigational oral small molecule Tau Morphomer™ inhibitor that will be studied in neurodegenerative diseases that are characterized by the presence of pathological Tau aggregates.

  3. NuCana Announces First Patients Dosed In Phase I Study Of NUC-7738 7/17/2019

    NuCana plc (NASDAQ: NCNA), a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer, today announced that the first patients have been dosed in the Phase I study of NUC-7738.

  4. uniQure Announces 36 Weeks Of Follow-Up Data From Phase IIb Study Of AMT-061 And Long-Term Follow-Up Data For AMT-060 In Patients With Hemophilia B 7/6/2019

    uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced updated clinical data on the three patients treated in the Company’s ongoing Phase IIb study of AMT-061, an investigational AAV5-based gene therapy containing a patent-protected FIX-Padua variant for the treatment of patients with severe and moderately severe hemophilia B. In addition, the Company presented up to 3.5 years of follow-up data on the 10 patients in the Phase I/II trial of AMT-060, its first-generation gene therapy for the treatment of hemophilia B.

  5. Amicus Therapeutics And Catalent Biologics Enter Strategic Partnership For Gene Therapy Development And Manufacturing 7/2/2019

    Amicus Therapeutics, Inc. (NASDAQ:FOLD) has entered into a strategic manufacturing agreement with Paragon Gene Therapy, a unit of Catalent Biologics, for clinical manufacturing capabilities and capacity for multiple active preclinical lysosomal disorder programs that are currently in development in collaboration with the University of Pennsylvania (Penn).

  6. ASIT Biotech Continues Its Transformation From Research To Late Stage Clinical Development 7/1/2019

    ASIT biotech (ASIT - BE0974289218), a clinical stage biopharmaceutical company focused on the research, development and future commercialization of breakthrough immunotherapy products for the treatment of allergies, announces that shareholders have approved all motions at the 28th June Extraordinary General Meeting of shareholders.

  7. Spring Bank Submits IND Application For SB 11285, An IV-Administered STING Agonist, For The Treatment Of Advanced Solid Tumors 7/1/2019

    Spring Bank Pharmaceuticals, Inc. (Nasdaq: SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and certain cancers, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the company’s intravenously (IV)-administered STimulator of INterferon Gene (STING) agonist development candidate, SB 11285, to initiate a Phase 1 trial with the principal goals of evaluating safety, tolerability and initial anti-tumor activity in patients with advanced solid tumors.

  8. ContraVir Pharmaceuticals Submits IND Application For CRV431 For NASH 6/27/2019

    ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis (“NASH”) and chronic viral infection, today announced the filing of an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for CRV431 for the treatment of NASH.

  9. Axsome Therapeutics Initiates GEMINI Phase 3 Trial Of AXS-05 In Major Depressive Disorder 6/24/2019

    Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, enrolled the first patient in its GEMINI (Glutamatergic and Monoaminergic Modulation in Depression) study, a Phase 3, randomized, double-blind, placebo-controlled trial of AXS-05 in the treatment of major depressive disorder (MDD).

  10. ContraVir Pharmaceuticals Receives Positive FDA Response To CRV431 Pre-IND Package For NASH 6/20/2019

    ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis (“NASH”) and chronic viral infection, today announced positive feedback from the U.S. Food and Drug Administration (“FDA”) in response to ContraVir’s pre-Investigational New Drug (“pre-IND”) meeting with respect to the development of CRV431 in NASH.