Core Insights - Relmada Therapeutics has appointed Dr. Yair Lotan as Chair of its Clinical Advisory Board, bringing significant expertise in bladder cancer care and clinical development to the NDV-01 program [2][3][4] - The Phase 3 trial for NDV-01 is expected to commence in the first half of 2026, building on positive Phase 2 data presented at the AUA 2025 Annual Meeting [2][4] Company Overview - Relmada Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapies for oncology and central nervous system conditions [11] - The lead candidate, NDV-01, is a sustained-release formulation of gemcitabine and docetaxel designed for bladder cancer treatment [9] Product Details - NDV-01 aims to provide a simple, ready-to-use formulation that enhances local drug exposure while minimizing systemic toxicity, with administration taking less than 10 minutes [9] - The product is protected by patents until 2038 and is designed to address the significant market opportunity in non-muscle invasive bladder cancer (NMIBC), which accounts for approximately 75% of all bladder cancer cases [10] Market Opportunity - NMIBC has a high recurrence rate of 50-75% over seven years, with over 600,000 prevalent cases in the U.S., indicating a substantial unmet need for effective treatment options [10] - NDV-01 has the potential to serve as a frontline or salvage therapy across multiple NMIBC subtypes [10] Leadership Insights - Dr. Lotan's extensive experience in bladder cancer and clinical research is expected to enhance the clinical development strategy for NDV-01 [3][4] - The leadership believes that Dr. Lotan's insights will be crucial in optimizing the product development plan and positioning NDV-01 for success [4] Clinical Development - The Clinical Advisory Board, chaired by Dr. Lotan, is anticipated to provide scientific insights and strategic advice to advance NDV-01 through clinical trials [4][6] - Initial Phase 2 data has been described as impressive, supporting NDV-01's potential as a class-leading therapy for NMIBC [4]