Relmada Therapeutics Licenses Phase 2 Bladder Cancer Candidate, NDV-01, from Trigone Pharma, Ltd.

Core Insights - NDV-01 is a novel sustained-release formulation of gemcitabine and docetaxel for treating non-muscle invasive bladder cancer (NMIBC), with a U.S. prevalence of approximately 600,000 patients and around 62,000 new diagnoses annually [1][2][15] - The first Phase 2 data for NDV-01 is expected to be reported at the American Urological Association meeting in April 2025 [1][2][7] Company Developments - Relmada Therapeutics has completed an exclusive licensing agreement with Trigone Pharma for NDV-01, which includes a $3.5 million upfront payment and 3,017,420 shares of common stock [2][10] - The agreement allows Relmada to pay up to $200 million in development, regulatory, and sales milestones, along with a 3% royalty on net sales [10] Clinical Program - NDV-01 is currently being evaluated in a Phase 2, Single-Arm Study to assess safety and efficacy in patients with high-grade NMIBC, with an enrollment target of up to 70 subjects [6] - The formulation is designed for intravesical dosing, providing a sustained release of the drug over a 10-day period, which may enhance treatment effectiveness and patient compliance [11][12] Market Opportunity - The NMIBC market is estimated to be a multi-billion dollar opportunity, driven by the high recurrence rates of bladder cancer and limited approved treatment options [16] - NDV-01's sustained-release formulation and ease of administration position it as a potential first-line therapy, with further opportunities for use in salvage treatments and other NMIBC subtypes [12][16] Strategic Outlook - Relmada aims to diversify its pipeline with NDV-01 and other assets, balancing risk and potential upside [5] - The company plans to host an investor update on NDV-01's development steps later in 2025 [9]