Relmada Therapeutics(US:RLMD) Globenewswire·2025-11-04 12:01Core Insights - Relmada Therapeutics announced positive 9-month follow-up safety and efficacy data for NDV-01 in non-muscle invasive bladder cancer (NMIBC), achieving a 92% overall response rate [1][3] - The FDA provided feedback supporting two potential registrational trials for NDV-01, one for 2nd line refractory BCG-unresponsive NMIBC and another for intermediate-risk NMIBC [1][4] - The company plans to initiate Phase 3 pivotal programs for NDV-01 in the first half of 2026 [2][8] FDA Meeting Outcomes - The FDA confirmed that no additional non-clinical studies are required for the 505(b)(2) New Drug Application (NDA) [4] - A single-arm trial for high-grade, 2nd line BCG-unresponsive NMIBC patients is considered acceptable by the FDA [4] - A randomized controlled trial proposal for intermediate-risk NMIBC was also deemed generally acceptable [4] Clinical Results - The 9-month follow-up data showed a complete response rate of 92% (23/25) for all patients, with 84% (21/25) at 3 months and 87% (20/23) at 6 months [3][5] - In the BCG-unresponsive subpopulation, the complete response rates were 91% (10/11) at any time, 82% (9/11) at 3 months, and 78% (7/9) at 6 months [6][12] Safety Profile - No new safety signals were reported, with no patients experiencing Grade 3 treatment-related adverse events (AEs) [11] - Among 36 enrolled patients, 61% experienced treatment-related AEs, primarily transient dysuria (62%) [11] Product Overview - NDV-01 is a sustained-release formulation of gemcitabine and docetaxel designed for intravesical administration, allowing for gradual drug release over 10 days [8] - The product is convenient to administer in-office, requiring less than 10 minutes and no specialized equipment [8] Market Opportunity - NMIBC accounts for 75-80% of all bladder cancer cases, with a significant market opportunity due to high recurrence rates and limited treatment options [9]