Relmada’s Withdrawn BOOST Trial Resets Expectations for NDV-01 and RLMD

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

The BOOST 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),” aimed to see if adding NDV-01 after tumor surgery could cut the chance of the cancer coming back. It targeted patients with intermediate-risk non-muscle invasive bladder cancer, a group where better local treatment could shift standard care and open a sizable market.

The trial tested NDV-01, a bladder-delivered, sustained-release mix of two older cancer drugs, gemcitabine and docetaxel. The goal was simple: keep the drug in the bladder longer after surgery to reduce tumor return while keeping side effects manageable compared with simple monitoring.

The study was planned as a Phase 3 interventional trial with patients randomly placed into one of two groups. One group would receive NDV-01 after surgery, while the other would be closely watched with regular checks, letting researchers compare active treatment with current observation practices.

The design used a parallel model, meaning both groups were treated and followed at the same time rather than in sequence. There was no masking, so doctors and patients knew who received NDV-01 and who was monitored, which simplifies operations but can add some bias that must be managed in the analysis.

The sponsor filed the study on December 29, 2025, signaling intent to move NDV-01 quickly into late-stage testing. The last update on March 15, 2026, shows the record is being actively maintained, a key point for investors tracking development momentum.

The overall status is now listed as “Withdrawn,” meaning the Phase 3 study did not move forward as planned. For investors, this removes a potential future revenue stream tied to NDV-01 in intermediate-risk bladder cancer and shifts focus back to Relmada Therapeutics, Inc.’s other assets and cash runway.

A withdrawn late-stage trial often weighs on sentiment, especially for small or mid-cap biotech names like RLMD that rely on a limited pipeline. Traders may now price in higher development risk and a longer path to meaningful cash flows, which can pressure valuation in the near term.

The bladder cancer field remains active, with multiple companies advancing chemo and immunotherapy approaches for non-muscle invasive disease. Competitors with similar intravesical products, or those with positive Phase 3 data, may see a relative advantage as NDV-01 exits the race in this setting.

For RLMD, capital allocation and strategic focus become more important, as investors will look for clear plans to either redeploy resources or refocus on programs with stronger odds of success. Any updates on partnering, portfolio pruning, or new indications could help steady the stock after disappointment around BOOST.

Although the BOOST trial has been withdrawn rather than continuing as an active study, the record remains updated, and further details on its status and history are available on the ClinicalTrials portal.

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