Relmada Pivots to Bladder Cancer Therapy, Abandoning Depression Drug After Trial Setback

NEW YORK, NY – November 13, 2025

Strategic Shift for Relmada Therapeutics

Relmada Therapeutics is undergoing a significant strategic recalibration, prioritizing its non-muscle invasive bladder cancer (NMIBC) program, NDV-01, after facing setbacks in the development of its lead depression candidate, esmethadone (REL-1017). The company announced in December 2024 that Phase 3 trials for esmethadone were unlikely to meet efficacy endpoints, prompting a difficult but necessary pivot. This change in direction highlights the inherent risks and dynamic nature of pharmaceutical development, where promising candidates can falter despite years of investment.

“The decision to discontinue the esmethadone program was not taken lightly,” stated a source close to the company. “However, the data suggested a low probability of success, and it was crucial to reallocate resources to assets with a more promising trajectory.”

NDV-01: A New Hope for NMIBC Patients

NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel, is now at the forefront of Relmada’s pipeline. The therapy has demonstrated encouraging results in Phase 2 trials, achieving a 91% complete response rate at six months. This strong performance has fueled optimism within the company and among analysts covering the sector. NMIBC represents a significant unmet medical need, with many patients requiring repeat procedures and facing the risk of disease progression. Current treatment options are often limited and associated with significant side effects.

“NDV-01 has the potential to revolutionize the treatment of NMIBC,” said a medical oncologist familiar with the data. “The sustained-release formulation could improve drug delivery to the bladder, leading to higher response rates and a more durable effect.”

Relmada is preparing for Phase 3 registrational trials of NDV-01, anticipating initiation in the first half of 2026. The company has already secured alignment with the FDA on two potential Phase 3 paths, suggesting a clear regulatory strategy. These trials will be critical in determining whether NDV-01 can gain approval and ultimately reach patients in need. The company’s strategic decision to prioritize this asset signifies a calculated risk, betting on a potentially transformative therapy in a crowded but underserved market.

Beyond Bladder Cancer: Compulsive Disorder Program Advances

While NDV-01 takes center stage, Relmada is also actively pursuing Sepranolone, a first-in-class GABAA modulating steroid antagonist, for the treatment of compulsive disorders. The company is focusing on Prader-Willi Syndrome (PWS) and plans to initiate a Phase 2 study in the first half of 2026. This program is built on positive proof-of-concept data observed in Tourette’s syndrome, providing some confidence in the potential of Sepranolone.

“The PWS market is particularly attractive due to the lack of effective treatments,” explained an industry analyst. “If Sepranolone can demonstrate meaningful improvements in compulsive behaviors, it could represent a significant advancement for patients and their families.”

This diversification of the pipeline, while seemingly a response to the esmethadone setback, demonstrates a strategic commitment to addressing unmet needs in neurological and psychiatric disorders. It allows Relmada to mitigate risk and potentially capitalize on multiple therapeutic opportunities.

Financial Implications and Investor Outlook

The shift in focus has implications for Relmada’s financial outlook. Discontinuing the esmethadone program will likely result in cost savings, but it also removes a potential revenue stream. Investors will be closely watching the progress of NDV-01 and Sepranolone to assess the company’s ability to generate future growth.

“The market will likely reward Relmada for making a decisive strategic move,” commented a financial analyst specializing in biotech companies. “However, the company needs to demonstrate that it can successfully execute its new plan and deliver positive clinical results.”

The company's ability to secure funding for the Phase 3 trials of NDV-01 and the Phase 2 study of Sepranolone will be crucial. Relmada may explore various financing options, including partnerships, licensing agreements, or public offerings. The company’s valuation will depend on the perceived potential of its pipeline and its ability to navigate the complex regulatory landscape. A strong investor reception to these changes will depend on the company’s ability to effectively communicate its new strategic direction and demonstrate a clear path to profitability.