Relmada’s BOOST Phase 3 Bladder Cancer Trial Sets Up a New Catalyst for RLMD Investors

Relmada Therapeutics Inc (RLMD) announced an update on their ongoing clinical study.

Relmada Therapeutics is preparing to launch a late-stage cancer trial that could reshape its long-term value story. The Phase 3 study, officially titled “A Phase 3, Randomized Study Evaluating the Efficacy and Safety of NDV-01 Versus Observation in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (BOOST),” will test whether adding Relmada’s bladder treatment to standard surgery can lower the chance of cancer coming back. For investors, this is a pivotal efficacy readout in a sizeable bladder cancer niche where unmet need remains high.

The trial focuses on NDV-01, a bladder-delivered (intravesical) treatment that combines two known chemotherapy agents, gemcitabine and docetaxel, in a sustained-release form. The idea is to keep the drug in the bladder longer, directly at the tumor site, to better prevent recurrences after the common surgical procedure known as TURBT (tumor removal via the bladder). The control group will receive only routine monitoring, allowing a clean comparison between active treatment and observation.

The study is interventional and randomized, meaning patients are assigned by chance to either NDV-01 or standard surveillance. It uses a parallel design, so both groups are treated and observed at the same time. The trial is open-label, so both doctors and patients know which approach is used, which is typical when one arm is “observation only.” The main goal is treatment-focused: to see if NDV-01 can extend the time patients stay disease-free compared with observation alone.

The study has not yet started recruiting. Key timing includes the initial submission on December 29, 2025, and the latest update filed on December 30, 2025, signaling an active setup phase. Primary completion and full completion dates are not listed yet, but investors should assume data will take several years to mature from first patient enrolled to final readout, given the need to track cancer recurrence over time.

For RLMD, this trial marks a strategic move into bladder cancer and adds a new, oncology-focused pillar to its pipeline. Positive Phase 3 data could support regulatory filings and open a new revenue stream in non–muscle invasive bladder cancer, a space currently dominated by treatments like BCG and various intravesical chemotherapies. Success could lift sentiment around Relmada’s R&D capabilities and support a higher valuation multiple, especially if the market views NDV-01 as a differentiated, device-like, sustained-release platform rather than just another chemotherapy mix. Conversely, delays in trial start, recruitment challenges, or weak data would likely weigh on the stock, given the binary nature of late-stage cancer programs. Competitors in bladder cancer drugs may feel indirect pressure if NDV-01 shows a strong recurrence benefit, but at this stage the main effect is on RLMD’s risk-reward profile, not on incumbents’ near-term sales.

The BOOST study is not yet recruiting but has been recently updated, and it remains an active, ongoing program with further details available on the ClinicalTrials portal.

To learn more about RLMD’s potential, visit the Relmada Therapeutics Inc drug pipeline page.