Relmada Therapeutics (RLMD) Leerink Global Healthcare Conference 2026 summary

Company overview and strategic focus

• Expanded from CNS-only to include oncology, aiming to lower risk while maintaining upside.

• NDV-01, a sustained-release intravesical gel for bladder cancer, is the primary focus for the next 1–2 years.

• NDV-01 targets hard endpoints and is designed for use in community urology practices.

Product profile and clinical data

• NDV-01 delivers gemcitabine/docetaxel in a gel, enabling 5-minute administration and sustained release over 10 days.

• Demonstrated 76% 12-month complete response (CR) in high-risk NMIBC, and 80% in BCG-unresponsive patients.

• Outperforms best-in-class comparators (46%–74% CR) and matches or exceeds standard Gem/Doce (60% CR).

• Safety profile is favorable, with only transient urinary discomfort.

Market opportunity and competitive landscape

• Only 15–20% of patients currently receive Gem/Doce, mostly in academic centers; NDV-01 aims to expand access to community settings.

• FDA-approved alternatives for BCG-unresponsive NMIBC show lower 12-month CR rates (19%–45%).

• NDV-01 is positioned for second-line therapy and intermediate-risk disease, with potential to be first with a second-line label.

• Competitors in intermediate risk include CG Oncology, Tyra, and J&J, but workflow and testing barriers exist.