On May 5, 2026 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, reported the presentation of two abstracts related to NDV-01 at the American Urology Association (AUA2026), taking place from May 15-18th in Washington D.C.
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Abstract Overview*
Abstract #1: Poster presentation: IP02-03: Prospective Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Sustained-Release Gemcitabine Docetaxel combination (NDV-01) in High-Risk NMIBC: Update with 9-month Complete Response Data
Session: IP02: Bladder Cancer: Non-Invasive I
Location: Room 146A, Walter E. Washington Convention Center
Presentation Date: Friday, May 15, 2026
Presentation Time: 7:00 AM to 9:00 AM ET
Abstract #2: Oral presentation: Trial in Progress: REL-NDV01-301 (BOOST) – A Phase 3, Randomized Study of Adjuvant Intravesical Sustained-Release Gemcitabine-Docetaxel (NDV-01) Versus Surveillance for the Treatment of Intermediate-Risk Non-Muscle Invasive Bladder Cancer.
Session: Clinical Trials in Progress: Bladder Cancer
Location: Hall B, The Square, Learning Lab, Walter E. Washington Convention Center
Presentation Date: Sunday, May 17, 2026
Presentation Time: 9:56 AM to 10:04 AM ET
*Exact conference presentation times and locations may be subject to change.
About NDV-01
NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for the treatment of non-muscle invasive bladder cancer. It is designed to enable Gem/Doce bladder retention and gradual drug release over 10 days. The formulation creates a soft matrix that enhances local exposure while minimizing systemic toxicity. The NDV-01 formulation is ready to use, convenient to administer in-office in less than 5 minutes and does not require anesthesia or specialized equipment. It is protected by patents through 2038.
About the Phase 2 Study
The Phase 2 study (NCT06663137) is an open-label, single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with high-grade non-muscle invasive bladder cancer (HG-NMIBC). Patients are treated with NDV-01 in a biweekly induction phase, followed by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy, as indicated. The primary efficacy endpoints are safety and complete response rate (CRR) at 12 months, and secondary efficacy endpoints are duration of response (DOR) and event free survival (EFS).
About NMIBC
NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence (50 – 80% over 5 years). With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. High-grade BCG-unresponsive disease represents one of the most difficult-to-treat NMIBC subtypes, with limited bladder-sparing options. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies. NDV-01 has the potential to serve as a frontline or salvage therapy and could be applicable across multiple NMIBC subtypes.
(Press release, Relmada Therapeutics, MAY 5, 2026, View Source [SID1234665128])