Venatorx and Melinta Provide Update on Status of U.S. New Drug Application for Cefepime-Taniborbactam
New England Journal of Medicine Publishes Positive Results of Cefepime-Taniborbactam from Phase 3
Venatorx and Menarini Enter Agreement for Cefepime-Taniborbactam
SHANGHAI, Aug. 15, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK)'s partner Venatorx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for cefepime-taniborbactam, an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic for the potential treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis. The FDA has granted Priority Review of the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of Feb. 22, 2024.
Venatorx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI), including Pyelonephritis, in Adults
MALVERN, Pa.--(BUSINESS WIRE)--Venatorx Pharmaceuticals, a private, clinical-stage pharmaceutical company focused on improving health outcomes for patients with difficult-to-treat drug resistant gram-negative bacterial infections and viral infections, today will present new data during IDWeek 2022 for its novel investigational antibiotic cefepime-taniborbactam. Two oral presentations will showcase cefepime-taniborbactam and highlight the safety and efficacy results from the recently completed pivotal Phase 3 complicated urinary tract infection clinical trial, CERTAIN-1. The presentations, along with the four other posters detailing additional cefepime-taniborbactam data at IDWeek 2022 (see release), will be available on the company’s website.
SHANGHAI, March 10, 2022 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK) announced today that its licensing partner, Venatorx Pharmaceuticals, reported positive results from its pivotal Phase 3 study, CERTAIN-1 (Cefepime Rescue with Taniborbactam in cUTI), evaluating cefepime-taniborbactam, an investigational new drug, versus meropenem as a potential treatment for hospitalized adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis.
MALVERN, Pa.--(BUSINESS WIRE)--Venatorx Pharmaceuticals today announced that it has two data presentations at IDWeek 2020, which is taking place virtually, starting today through October 25, 2020.