Relmada Therapeutics Reports Promising 12-Month Phase 2 Data for NDV-01 in Non-Muscle Invasive Bladder Cancer

Key Highlights from the Report

• NDV-01 achieves a durable 76% complete response (CR) rate at 12 months in high-risk NMIBC patients.
• BCG-unresponsive patients demonstrated an impressive 80% CR rate at 12 months, with a 94% CR rate at any time.
• No progression to muscle-invasive disease or need for radical cystectomy was observed in the study.
• Favorable safety profile: No ≥ Grade 3 treatment-related adverse events (AEs) and no treatment-related discontinuations.
• NDV-01 is advancing into a Phase 3 RESCUE registrational program, targeting both 2L BCG-unresponsive and adjuvant intermediate-risk NMIBC, with initiation expected in mid-2026.

Detailed Analysis for Investors

Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage biotechnology company, announced strong 12-month interim results from its ongoing Phase 2 trial of NDV-01 in high-risk non-muscle invasive bladder cancer (NMIBC). These results underscore NDV-01’s potential as a best-in-class therapy, particularly for patients unresponsive to Bacillus Calmette-Guérin (BCG) – a population with significant unmet medical need.

Clinical Efficacy Data

• Overall, the 12-month complete response (CR) rate in high-risk NMIBC patients was 76%, with a 95% CR rate at any time during the study.
• For the difficult-to-treat BCG-unresponsive subpopulation:
  • 12-month CR rate was 80%, and 94% achieved CR at any time.
  • At 12 months, Kaplan-Meier analysis showed an 84% CR rate.
  • No patients progressed to muscle-invasive disease.
  • No patients required radical cystectomy—a significant outcome for bladder-sparing therapy.

Safety and Tolerability

• No ≥ Grade 3 treatment-related adverse events.
• No patients discontinued due to adverse events.
• Among the 48 patients treated:
  • 63% experienced treatment-related AEs, mostly mild and transient.
  • 54% reported transient dysuria (uncomfortable urination, Grade 1, <24 hours).
  • 8% had asymptomatic positive urine cultures.
  • 8% experienced hematuria.

Phase 3 RESCUE Registrational Program Details

Based on these promising results, Relmada is advancing NDV-01 into pivotal Phase 3 trials in mid-2026, with two registration pathways:

1. Adjuvant Intermediate-Risk NMIBC (Pathway 1):
   • An open-label, randomized, controlled trial comparing NDV-01 to observation after TURBT (transurethral resection of bladder tumor).
   • This patient group currently has no approved adjuvant therapies, representing an estimated 75,000 US patients per year.
   • Primary endpoint: Disease Free Survival (DFS).
   • Secondary endpoints: High-grade recurrence-free survival, progression-free survival, quality of life metrics.
2. 2L BCG-Unresponsive NMIBC (Pathway 2):
   • A single-arm trial in patients with carcinoma in situ (CIS) who are refractory to first-line therapies.
   • This is a high unmet need population, estimated at 5,000 US patients per year.
   • Primary endpoint: Complete response rate at any time.
   • Key secondary endpoints: Duration of response, progression-free survival, and recurrence-free survival among responders.

Product Differentiation and Market Opportunity

• NDV-01 is a sustained-release, intravesical (bladder-administered) formulation of gemcitabine and docetaxel, designed for convenience and broad adoption:
  • Ready-to-use and administered in-office in under 5 minutes.
  • No need for anesthesia or specialized equipment.
  • Patent protection through 2038.
  • Potentially streamlines workflow for community urology practices, where approximately 80% of NMIBC patients are treated.
• The NMIBC market is substantial:
  • NMIBC accounts for 75-80% of bladder cancer cases, with high recurrence rates (50-80% within 5 years).
  • Over 744,000 prevalent cases in the US, and significant unmet needs, especially for BCG-unresponsive and intermediate-risk patients.

Upcoming Catalysts

• NDV-01 US IND clearance expected mid-2026.
• Phase 3 RESCUE program to initiate mid-2026.
• Initial 3-month results from the Phase 3 2L BCG-unresponsive study anticipated by year-end 2026.

Potential Price Sensitive Information for Shareholders

• The robust 12-month efficacy and tolerability data for NDV-01 positions it as a potential best-in-class therapy in a large, underserved market, with pivotal Phase 3 trials on the near-term horizon. This could significantly impact Relmada’s valuation and investor sentiment.
• The advancement into Phase 3 and the potential for NDV-01 to become the first approved adjuvant therapy for intermediate-risk NMIBC (a market with 75,000 US patients annually) or a new standard for BCG-unresponsive disease (5,000 patients annually) is highly material.
• NDV-01’s favorable safety and tolerability profile, combined with its practical advantages for office-based administration, could drive rapid adoption if approved, differentiating it from competitors and existing therapies.

Important Details for Investors

• NDV-01’s patent protection extends through 2038, providing a long runway for potential market exclusivity.
• The company’s lead pipeline candidates, NDV-01 and sepranolone, are both advancing through mid-stage development, targeting significant unmet needs in oncology and CNS disorders.
• Shareholders should monitor the upcoming IND clearance, Phase 3 initiation, and initial efficacy readouts as key inflection points for the stock.
• Relmada’s ability to secure sufficient funding and drug supply, as well as regulatory alignment with the FDA, will be critical for continued progress and value creation.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially. Investors should consult the company’s filings with the SEC and their own financial advisors before making investment decisions.

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