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)...
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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...
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 enrollment of the first patient into part 2 of G203 (NCT05303519), a global, randomized study evaluating the efficacy and safety of safusidenib versus placebo...
NEW YORK – Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for...
FORT LEE, N.J. — Nuvectis Pharma, Inc. (NASDAQ: NVCT) (“Nuvectis” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced that NXP800 was granted Orphan Drug Designation by the United States...
Fort Lee, NJ — Nuvectis Pharma, Inc., a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced a collaboration with Mayo Clinic to evaluate NXP800 in an Investigator-sponsored clinical trial in cholangiocarcinoma. Mitesh Borad,...
Tokyo, Japan and Cambridge, UK – Nxera Pharma Co. Ltd (TSE 4565) – formerly known as Sosei Group or Sosei Heptares – announces it has joined the World Orphan Drug Alliance (WODA), a global alliance of commercial distributors dedicated to providing access to treatments for rare diseases and specialty medicines...
WATKINS GLEN, N.Y. (WETM) – Liam Hickey, 6, is one in a million, so it is only fitting he had a special experience at Watkins Glen International race track. The Hickey family has been through some challenging times. Liam was diagnosed with a rare skeletal disease and has undergone several...
