RLMD Stock Surges 42% in a Week: Here's What You Should Know

Core Insights - Relmada Therapeutics (RLMD) shares surged 42% in one week following the announcement of positive 12-month interim data from a mid-stage study of NDV-01 for high-risk non-muscle invasive bladder cancer (NMIBC) [2][6] Study Results - The phase II study of NDV-01 demonstrated a 12-month complete response (CR) rate of 76%, with CR rates of 87% at three months, 86% at six months, and 85% at nine months [3][6] - In the BCG-unresponsive subgroup, NDV-01 achieved a 12-month CR rate of 80%, with no patients progressing to muscle-invasive disease or requiring radical cystectomy [4][6] Safety Profile - NDV-01 exhibited a favorable safety profile, with treatment-related adverse events mostly mild to moderate, and no discontinuations due to adverse events reported [5][6] Future Development Plans - Relmada Therapeutics plans to advance NDV-01 into the phase III RESCUE registrational program targeting both second-line BCG-unresponsive and adjuvant intermediate-risk NMIBC settings, with program initiation expected in mid-2026 [4][7][11] - The first pathway will evaluate NDV-01 as an adjuvant therapy for intermediate-risk NMIBC patients, with disease-free survival as the primary endpoint [8] - The second pathway will focus on a single-arm study in second-line BCG-unresponsive NMIBC patients, with the primary endpoint being the CR rate at any time [9][11]