Core Insights - Relmada Therapeutics reported a 92% overall response rate for NDV-01 in non-muscle invasive bladder cancer (NMIBC) with favorable safety data [1][3][5] - The company secured FDA alignment on key elements of its Phase 3 program for NDV-01, which includes two independent paths for approval targeting high-risk and intermediate-risk NMIBC patients [1][3][8] - Relmada completed a $100 million underwritten offering to support its operations and planned studies into 2028 [1][3][12] Clinical Results - NDV-01 demonstrated a 92% complete response rate at any time point, with 84% at 3 months, 87% at 6 months, and 85% at 9 months [5][6] - In the BCG-unresponsive subpopulation, the complete response rate was 91% at any time point [7] - No patients progressed to muscle-invasive disease or underwent radical cystectomy [6] FDA Alignment and Study Design - FDA indicated that a single-arm trial may be acceptable for high-risk, 2nd line BCG-unresponsive patients [5][8] - For intermediate-risk NMIBC, a randomized study design post-TURBT was deemed generally acceptable [5][8] - No further non-clinical studies are required to support a 505(b)(2) New Drug Application [5] Financial Results - For Q3 2025, Relmada reported a net loss of $10.1 million, or $0.30 per share, compared to a net loss of $21.7 million, or $0.72 per share in Q3 2024 [13][28] - Research and development expenses were $4.0 million, down from $11.1 million in Q3 2024 [12][28] - General and administrative expenses decreased to $6.3 million from $11.9 million in Q3 2024 [12][28] Upcoming Milestones - NDV-01 twelve-month data from the ongoing Phase 2 NMIBC study is expected in Q1 2026 [12] - Initiation of Phase 3 trials for NDV-01 in high-risk and intermediate-risk settings is anticipated in the first half of 2026 [12][8] - A Phase 2 trial for sepranolone in Prader-Willi Syndrome is also set to begin in the first half of 2026 [12]