Relmada’s NDV-01 Delivers 92% Response Rate and 61% Stock Surge
Relmada Therapeutics’ NDV-01 bladder cancer therapy showed a 92% complete response rate at nine months with no progression to muscle-invasive disease in its 12-month Phase 2 interim readout, driving a 61.1% stock surge. Analysts forecast $2.3 billion peak sales, while Phase 3 trials are slated to begin H1 2026.
1. Interim Phase 2 Readout Spurs 61% Rally
Relmada released its 12-month interim data for NDV-01 showing a 92% complete response rate at nine months with zero progression to muscle-invasive disease, prompting a 61.1% share price increase as investors digested the primary endpoint result.
2. Commercial Potential and Phase 3 Roadmap
With a market capitalization of about $525 million and a $2.3 billion peak sales projection, NDV-01 targets non-muscle-invasive bladder cancer patients treated in community urology settings; the FDA has aligned on a single-arm trial for high-grade BCG-unresponsive disease and a randomized study for intermediate-risk patients, both initiating in H1 2026.