Relmada's NDV-01 Shows 76% Durable Response in Bladder Cancer Trial — Relmada Therapeutics, Inc.

Event summary

Relmada Therapeutics reported 12-month Phase 2 interim data for NDV-01 in non-muscle invasive bladder cancer (NMIBC), showing a 76% complete response rate at 12 months and 95% at any time in high-risk patients.
BCG-unresponsive patients achieved an 80% complete response rate at 12 months and 94% at any time.
No ≥ Grade 3 treatment-related adverse events or discontinuations were reported, reinforcing the favorable safety profile.
Relmada plans to advance NDV-01 into the Phase 3 RESCUE registrational program in mid-2026.

The big picture

Relmada's positive Phase 2 data for NDV-01 underscores the potential of its novel sustained-release formulation in addressing a significant unmet need in NMIBC, particularly in the challenging BCG-unresponsive population. The favorable safety profile and high response rates position NDV-01 as a potential best-in-class therapy, setting the stage for a pivotal Phase 3 program. The market opportunity is substantial, with over 744,000 prevalent cases of NMIBC in the U.S. and limited treatment options for high-grade BCG-unresponsive disease.

What we're watching

Regulatory Pathways: Whether the Phase 3 RESCUE program will successfully navigate the FDA's requirements for both BCG-unresponsive and adjuvant intermediate-risk NMIBC indications.
Market Adoption: The pace at which NDV-01 can gain traction in community urology practices, given its simplified administration and favorable safety profile.
Competitive Positioning: How NDV-01's sustained-release formulation and high response rates will position it against existing and emerging therapies for NMIBC.