Relmada to Showcase 12-Month Phase 2 NDV-01 Data and Phase 3 Overview
Relmada will present 12-month Phase 2 NDV-01 data in high-risk non-muscle invasive bladder cancer on May 15, 2026 and a Phase 3 RESCUE program overview on May 17, 2026 at AUA2026. The registrational RESCUE trial remains on track to initiate mid-2026 following this clinical update.
1. AUA2026 Presentations
Relmada will present two abstracts on NDV-01 at the American Urology Association meeting in Washington D.C., showcasing 12-month Phase 2 efficacy and safety data in high-risk NMIBC on May 15 and a Phase 3 BOOST trial overview on May 17.
2. NDV-01 Formulation and Purpose
NDV-01 is a sustained-release intravesical formulation combining gemcitabine and docetaxel in a soft matrix designed for 10-day bladder retention, enhancing local drug exposure while minimizing systemic toxicity, ready for in-office administration without anesthesia or special equipment.
3. Clinical Development Timeline
The open-label Phase 2 study evaluates safety and complete response rate at 12 months with biweekly induction and monthly maintenance, while the RESCUE Phase 3 registrational program is on track to begin mid-2026 to address intermediate-risk NMIBC lacking approved adjuvant therapies.