Relmada Therapeutics to Host KOL Event on Phase 2 NDV-01 Data

Company Overview - Relmada Therapeutics, Inc. is a clinical-stage biotechnology company focused on advancing innovative therapies for targeted patient populations [11] - The lead investigational program, NDV-01, is being evaluated for high-grade non-muscle invasive bladder cancer (HG-NMIBC) in a Phase 2 study [12] Product Details - NDV-01 is a novel, investigational sustained-release formulation of gemcitabine and docetaxel, designed for intravesical therapy [3][6] - The formulation aims to maximize local drug concentration while minimizing systemic toxicity, providing a gradual and sustained release over a 10-day period [7] - NDV-01 has the potential to be a first-line therapy for HG-NMIBC and may also be used in patients who have failed other treatments, including BCG immunotherapy [10] Market Opportunity - The U.S. prevalence of non-muscle invasive bladder cancer (NMIBC) is approximately 600,000 patients, with an estimated 62,000 new diagnoses annually [3][9] - The NMIBC market is considered a multi-billion dollar opportunity, driven by the increasing incidence of bladder cancer and the demand for effective therapies [10] - High recurrence rates in NMIBC lead to frequent re-treatment, highlighting the need for effective and minimally invasive therapies like NDV-01 [10] Upcoming Event - A virtual key opinion leader (KOL) event will be held on April 28, 2025, featuring discussions on topline efficacy and safety data from the Phase 2 study of NDV-01 [1][2]