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....
treatment News
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...
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 initiation of the Phase 2 portion of ALKOVE-1, its Phase 1/2 clinical trial of NVL-655 for patients with ALK-positive non-small cell lung cancer (NSCLC)...
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 U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to NVL-520 for the treatment of patients with ROS1-positive metastatic...
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 positive topline pivotal data for neladalkib, an investigational ALK-selective inhibitor, in tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) from the global ALKOVE-1...
NEW YORK, NY — Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced the publication of positive results from a Phase 2 study of safusidenib, a novel, oral, potent, brain-penetrant targeted inhibitor of mutant IDH1, in patients...