Urovant Sciences Ltd (NASDAQ:UROV) reported the submission of New Drug Application (NDA) for vibegron for the treatment of overactive bladder (OAB).
The Swiss-based company, which also has headquarters in Irvine, California, said Monday the NDA for vibegron is supported by an extensive clinical development program, which included over 4,000 patients with OAB. In a pivotal efficacy and safety study, once-daily 75mg vibegron met all primary and key secondary efficacy endpoints, and demonstrated a favorable safety profile.
Said CEO Keith Katkin, "Our NDA submission for vibegron is a significant milestone for our company and brings us one step closer to potentially providing a new oral therapy to a highly dissatisfied market.
"The symptoms of overactive bladder affect over 30 million people in the U.S. Vibegron, if approved next year, would be the first new branded prescription drug for the treatment of OAB in nearly a decade."
Vibegron is a once-daily beta-3 adrenergic agonist under investigation for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Urovant is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions.
UROV shares hiked $1.46, or 11.1%, to $14.56
