Relmada Therapeutics, a clinical-stage biotechnology company developing innovative therapies for oncology and central nervous system disorders, today announced positive regulatory and clinical updates for NDV-01, its novel investigational therapy for non-muscle invasive bladder cancer (NMIBC).

The U.S. Food and Drug Administration (FDA) has provided feedback supporting two separate registrational study pathways for NDV-01 in NMIBC. The FDA confirmed that Relmada may pursue a registrational trial in second-line, refractory, Bacillus Calmette–Guérin (BCG)-unresponsive NMIBC and a randomized controlled trial in intermediate-risk NMIBC. The agency also confirmed that no additional non-clinical studies are required to support a 505(b)(2) New Drug Application (NDA) for NDV-01.

Relmada expects to initiate its Phase 3 program in the first half of 2026, incorporating both independent studies for potential approval in two distinct NMIBC indications. In the high-grade, second-line BCG-unresponsive population, the FDA noted that a single-arm trial may be acceptable for more refractory patients. For the intermediate-risk NMIBC population, the FDA agreed that a randomized study comparing adjuvant NDV-01 to observation following transurethral resection of bladder tumor (TURBT), using a time-to-event endpoint, would be appropriate.

“The positive outcome of our Type B meeting and alignment with the FDA mark an important milestone for Relmada and NDV-01,” said Dr. Raj Pruthi, Chief Medical Officer – Urology, Relmada Therapeutics. “The FDA’s guidance provides a clear and efficient path forward for NDV-01, offering hope to patients with NMIBC who currently face limited treatment options. A single-arm registrational study in high-grade, refractory BCG-unresponsive patients could provide a rapid route to approval, while a second pivotal study in intermediate-risk NMIBC could further expand NDV-01’s potential use and accessibility.”

Sergio Traversa, Chief Executive Officer of Relmada Therapeutics, added, “We integrated NDV-01 into our portfolio because of its strong potential to redefine NMIBC treatment. The FDA’s support reinforces our confidence in its clinical and regulatory prospects. We believe NDV-01 could become a best-in-class, durable, bladder-sparing, and easy-to-administer in-office therapy. We look forward to beginning the Phase 3 programs in early 2026.”

Relmada also reported encouraging 9-month follow-up results from its ongoing Phase 2 study of NDV-01 in NMIBC, demonstrating sustained efficacy and a favorable safety profile. NDV-01 achieved a 92 per cent overall response rate at any time point, with no patients progressing to muscle-invasive disease or requiring radical cystectomy. Two patients who reached the 12-month assessment maintained a complete response. The safety profile remained consistent, with no new safety signals observed. The most common treatment-related adverse events were mild and transient, including dysuria, asymptomatic positive urine culture, and hematuria.

These findings further highlight NDV-01’s potential as a safe, effective, and convenient therapy for patients with NMIBC, addressing a critical unmet need in bladder cancer care.