News -
Our Programs
Our lead program, NDV-01 for non-muscle invasive bladder cancer (NMIBC), is a sustained-release formulation of gemcitabine and docetaxel (Gem/Doce) designed to build on the established clinical activity of conventional Gem/Doce. It enables prolonged bladder exposure and controlled local drug release, while simplifying treatment through a ready-to-use, in-office procedure.
NDV-01 is advancing into the Phase 3 RESCUE registrational program, expected to initiate in mid-2026. Our second program, sepranolone, targets compulsive behaviors through modulation of GABAA receptor activity and is advancing toward a Phase 2 trial in Prader-Willi syndrome, expected to initiate in mid-2026.
Pipeline overview
NDV-01
NDV-01 is a sustained-release intravesical formulation of gemcitabine and docetaxel (Gem/Doce) designed to enable prolonged bladder exposure and controlled local drug release, while simplifying administration in the clinical setting. Designed for real-world use, NDV-01 enables streamlined, in-office administration in <5 minutes, supporting broad adoption across community and academic urology practices.
NDV-01 is advancing into the Phase 3 RESCUE registrational program, expected to initiate in mid-2026, with two independent approval pathways in second-line (2L) BCG-unresponsive NMIBC and the adjuvant intermediate-risk setting.
Learn more about NDV-01
Sepranolone
Sepranolone is a novel clinical candidate targeting compulsive behaviors through modulation of GABAA receptor activity. Prior clinical and preclinical data support the potential for Sepranolone to have a beneficial effect on food craving, appetite and compulsive behaviors.
Sepranolone is advancing toward a Phase 2 trial in Prader-Willi syndrome, a rare genetic disorder characterized by hyperphagia and compulsive behaviors, with initiation expected in mid-2026.
Learn more about SepranoloneEvents
View all eventsEvent - May 27, 2026 9:30 AM EDT
