UPDATE -- Relmada Therapeutics To Present NDV-01 Data at AUA2025

Company Overview - Relmada Therapeutics, Inc. is a clinical-stage biotechnology company focused on advancing innovative therapies for targeted patient populations [7] - The lead investigational program, NDV-01, is aimed at treating High-Grade Non-Muscle Invasive Bladder Cancer (HG-NMIBC) and is currently in a Phase 2 study [8] Product Details - NDV-01 is an investigational sustained-release formulation combining gemcitabine and docetaxel, designed for intravesical dosing without the need for anesthesia or specialized equipment [2][3] - The formulation aims to maximize local drug concentration and prolong exposure while minimizing systemic toxicity, with a gradual release over a 10-day period [3] - NDV-01 has the potential to be a first-line therapy for HG-NMIBC and may also be used for patients who have failed other treatments, including BCG immunotherapy [3][6] Market Opportunity - The U.S. market for Non-Muscle Invasive Bladder Cancer (NMIBC) is estimated to be a multi-billion dollar opportunity, driven by the increasing incidence of bladder cancer and the demand for effective therapies [6] - NMIBC has a high recurrence rate of 50-75% over seven years, leading to frequent re-treatment and progression, highlighting the need for effective solutions like NDV-01 [5][6] - The global market is expected to grow significantly, with limited approved treatment options currently available [6] Clinical Presentation - An abstract regarding NDV-01 will be presented at the American Urology Association (AUA2025) conference on April 28, 2025, at 10:04 AM PT [2]