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 for bladder cancer is now the primary focus for the next 1–2 years.

• NDV-01 leverages a proven mechanism and targets hard endpoints in uro-oncology.

NDV-01 product and clinical data

• NDV-01 is a sustained-release intravesical gel delivering Gem/Doce, enabling administration in under five minutes.

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

• Outperforms best-in-class comparators, with 84% CR in papillary disease versus 74%, and 46% CR in CIS for other approved drugs.

• Safety profile is favorable, with only transient discomfort and no significant new tolerability issues.

Market opportunity and competitive landscape

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

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

• NDV-01 aims to be first with a second-line label, targeting both high-risk and intermediate-risk populations.

• Intermediate-risk bladder cancer represents a larger market (75,000–80,000 patients) with high recurrence rates.