Relmada Therapeutics presents NDV-01 Phase 2 data showing 77% complete response rate at 12 months
RLMD•Relmada Therapeutics reported interim Phase 2 NDV-01 complete response rates of 94% overall and 77% at 12 months in high-risk bladder cancer. It plans to file an investigational new drug application by year-end 2026.
1. Interim response data
Relmada Therapeutics reported interim Phase 2 NDV-01 complete response rates of 94% overall and 77% at 12 months in high-risk bladder cancer. No grade 3 or higher treatment-related adverse events occurred, and no patients discontinued because of treatment-related adverse events.
2. Long-term follow-up
At 18 months, 12 of 14 evaluable patients in the long-term extension remained in complete response; two patients developed muscle-invasive disease at month 15.
3. Planned development
The planned SPECTRUM program includes independent registrational cohorts of 87 high-risk patients and 276 intermediate-risk patients, with enrollment in the latter under review. Relmada plans to submit an investigational new drug application for NDV-01 by year-end 2026, with registrational trials starting upon clearance.
