Urovant Sciences Ltd (NASDAQ: UROV) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval of once-daily, 75mg vibegron for the treatment of patients with an overactive bladder.
"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," said Keith Katkin, CEO of Urovant in a statement.
"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."
Urovant Sciences shares were trading up 10.69% at $14.50 in Tuesday’s pre-market session. The stock has a 52-week high of $14.49 and a 52-week low of $5.82.