Relmada Therapeutics will present two NDV‑01 abstracts at the American Urology Association (AUA) meeting in Washington, D.C., scheduled for Friday, May 15 and Sunday, May 17, 2026. The first abstract, a poster (IP02‑03), will provide a 9‑month complete‑response update from a prospective open‑label study of intravesical sustained‑release gemcitabine‑docetaxel (NDV‑01) in high‑risk non‑muscle invasive bladder cancer. The second abstract, an oral presentation (REL‑NDV01‑301), will report on the ongoing Phase 3 BOOST trial, a randomized study comparing NDV‑01 versus surveillance in intermediate‑risk NMIBC patients.
The presentations mark a key milestone in Relmada’s clinical program, moving NDV‑01 from early‑stage data toward regulatory submission and potential market entry. The 9‑month CR update builds on the Phase 2 interim data that showed a 76% complete‑response rate at 12 months in high‑risk patients and 80% in BCG‑unresponsive patients, underscoring the drug’s potential to address unmet needs in NMIBC.
The Phase 3 BOOST trial, a randomized study of NDV‑01 versus surveillance, is part of the company’s strategy to secure FDA approval for both second‑line BCG‑unresponsive NMIBC and adjuvant intermediate‑risk NMIBC. FDA feedback has supported registrational study designs for these indications, and the company anticipates initiating the Phase 3 trials in mid‑2026.
By presenting at AUA2026, Relmada aims to engage the urology community, gather expert feedback, and refine its clinical development plan ahead of the final data readout. The company’s sustained‑release formulation offers a convenient, in‑office administration that could improve patient adherence and reduce systemic toxicity compared to conventional gemcitabine‑docetaxel.
The event underscores Relmada’s progress in a market where NMIBC accounts for 75‑80% of bladder cancer cases and high recurrence rates drive demand for new therapies. The company’s focus on a high‑risk, BCG‑unresponsive population positions NDV‑01 to fill a significant unmet need and potentially capture a sizable share of the NMIBC treatment market.
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