STEVENAGE, United Kingdom — NRG Therapeutics Ltd. (“NRG”), a clinical stage neuroscience company targeting a novel mechanism to rectify mitochondrial dysfunction in neurodegenerative diseases, is pleased to announce that the first participants have been dosed in its first-in-human Phase 1 clinical trial of its lead candidate NRG5051 which is being...
treatment News
PARAMUS, N.J. — NS Pharma, Inc. (NS Pharma), a biopharmaceutical leader in rare disease and subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku), announced today that the National Center of Neurology and Psychiatry (NCNP, Kodaira City; President, Kazuyuki Nakagome) presented 3.5-year efficacy and safety data from the open-label extension of...
PARAMUS, N.J. — NS Pharma, Inc., a subsidiary of Nippon Shinyaku Co., Ltd., announced that, on December 13, 2023, the European Commission (EC) has granted orphan drug designation for NS-089/NCNP-02, which is being developed for the treatment of Duchenne muscular dystrophy (Duchenne), a rare and deadly genetic disorder that occurs...
CHICAGO, Illinois — Nucleai, a spatial AI biomarker company that deciphers cellular conversations and maps cellular interactions within tissue samples to predict therapeutic outcomes, will showcase its developments in cancer research and diagnostics at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, California from April 5-10,...
TORONTO, Canada and HAIFA, Israel — NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (NRX.V), known as “NurExone,” is pleased to announce the initiation of the Orphan Drug Designation process with the European Medicines Agency (EMA) for its groundbreaking ExoPTEN product, currently in development for patients with acute spinal cord injury....
BRISBANE, Calif. — Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines in oncology and autoimmune disease, today presented new clinical data from patients with relapsed or refractory Waldenström macroglobulinemia (WM) treated in the Phase 1 clinical trial...
Complete response achieved in CLL; overall objective response rate of 80.9% in CLL patients and 84.2% in patients with WM Bexobrutideg was well tolerated with no new safety signals observed with longer duration on study or higher doses Data reinforces Nurix’s scientific leadership and platform strength in targeted protein degradation...
CAMBRIDGE, Mass. – Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for zidesamtinib, an investigational ROS1-selective inhibitor, for the treatment of adult patients...
Aligned with FDA on NDA submission strategy for TKI pre-treated patients with advanced ROS1-positive NSCLC and participation in Real-Time Oncology Review; the company plans to initiate a rolling NDA submission in July 2025 with target completion in the third quarter of 2025 In 117 ROS1 TKI pre-treated patients, including 50%...
CAMBRIDGE, Mass. — Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the first patient has been dosed in ALKAZAR, the company’s global Phase 3 randomized, controlled trial evaluating neladalkib for TKI-naïve patients with advanced ALK-positive non-small cell lung cancer...