Relmada Therapeutics Steers Course for a Promising Future
In a recent conference call, Relmada Therapeutics provided an update on its fourth quarter and full year 2025 financial results. The company reported significant progress in its lead program, NDV-01, which is being developed for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).
According to Dr. Sergio Traversa, Relmada's CEO, 2025 has been a transformational year for the company, marked by substantial progress in its lead program, NDV-01. The company reported compelling responses and durable 12-month efficacy data for its ongoing phase II study of NDV-01. This was achieved through the sustained release formulation of gemcitabine and docetaxel.
The FDA has aligned with Relmada's planned registration of its phase III RESCUE program, which will focus on two independent registrational pathways: adjuvant therapy following TURBT in patients with intermediate-risk bladder cancer, affecting about 75,000 patients in the United States, and second-line treatment BCG-unresponsive patients, representing about 5,000 patients in the United States.
In addition to its progress on NDV-01, Relmada also highlighted its plans for Sepranolone, a product candidate that has previously demonstrated proof of concept in Tourette syndrome. The company is set to begin a proof-of-concept study in Prader-Willi syndrome in the middle of this year.
Relmada's team has been strengthened with the appointment of Dr. Raj S. Pruthi as Chief Medical Officer-Oncology, and a scientific advisory board comprising distinguished peers has been established to support the NDV-01 program.
The company's financial strength has also been bolstered through a successful $160 million private financing round, providing it with capital through 2029 and covering the planned completion of its NDV-01 program. This investment is expected to enable Relmada to continue making significant progress in its lead programs."
