Relmada Therapeutics Outlines 2026 Trial Launches for NDV-01 and Sepranolone as Pipeline Advances

Relmada Therapeutics has outlined 2026 trial launches for NDV-01 and sepranolone, two product candidates that have shown proof-of-concept data and good safety profiles. NDV-01 is for non-muscle invasive bladder cancer (NMIBC), while sepranolone is for compulsivity disorders. The addition of these candidates advances Relmada's pipeline and suggests growth opportunities for the company in the future.

Relmada Therapeutics, Inc. (RLMD) has outlined plans to launch clinical trials for two promising product candidates in 2026. NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel, is being developed for high-grade/intermediate-grade non-muscle invasive bladder cancer (NMIBC). Sepranolone, a first-in-class GABAA Modulating Steroid Antagonist, is being explored for Prader-Willi Syndrome (PWS), Tourette Syndrome (TS), and Essential Tremor (ET).

The company's CEO, Sergio Traversa, highlighted the potential of these candidates during the Q2 2025 earnings call. He stated that both NDV-01 and sepranolone have demonstrated proof-of-concept data and good overall safety in initial studies. Traversa emphasized that both programs target significant and underserved markets with the potential to expand beyond their first indications [1].

The 6-month follow-up from the Phase II study of NDV-01 showed a 91% overall response rate at any time point, with good overall safety. This impressive result raises confidence in NDV-01 as a potential durable treatment for bladder cancer. The company is preparing to initiate a Phase III registration-track study for NDV-01 in the first half of 2026 [2].

Sepranolone is expected to enter a Phase II study in PWS in the first half of 2026. The company is focusing on completing study preparations, including interactions with the FDA and transfer of production to a contract manufacturer.

Relmada's pipeline advancement suggests growth opportunities for the company in the future. The company's strategic focus shifted from initial proof-of-concept data and planning IND clearance to reporting updated 6-month efficacy and safety data, and outlining concrete Phase III/II trial timelines. The addition of senior urology experts to the team and a more detailed discussion of regulatory strategy represented new developments.

The company's financial results for Q2 2025 showed a net loss of $9.9 million, down from $17.8 million in Q2 2024. R&D expenses decreased to $2.8 million, driven by lower study costs and the wind-down of clinical trials for REL-1017, partially offset by an increase in costs associated with the ramp-up of NDV-01 and sepranolone activities.

Relmada's management remains focused on a disciplined financial approach and expressed confidence in the pipeline’s ability to deliver value as development milestones approach. The company's strategic priorities include regulatory engagement, study preparations, and completing Phase III and Phase II trials in 2026.

References:
[1] https://seekingalpha.com/news/4482792-relmada-outlines-2026-trial-launches-for-ndvminus-01-and-sepranolone-as-pipeline-advances
[2] https://www.relmada.com/for-investors/news/detail/322/relmada-therapeutics-reports-second-quarter-2025-financial