Relmada Therapeutics shares rise 11.82% premarket after positive Phase 2 data for NDV-01 in NMIBC show 92% complete response rate.

Relmada Therapeutics surged 11.82% in premarket trading following the announcement that its Phase 2 trial data for NDV-01 in non-muscle invasive bladder cancer (NMIBC) showed a 92% complete response rate and favorable safety. The company plans to advance NDV-01 into Phase 3 studies in H1 2026, targeting two NMIBC indications that represent 80% of new cases annually in the U.S. The data, presented at the Society of Urologic Oncology 2025 meeting, highlights NDV-01’s potential as a bladder-sparing, in-office therapy with a well-defined regulatory path post-FDA discussions. This milestone underscores the drug’s viability in addressing a high-unmet-need market and aligns with the stock’s upward trajectory.