Typically, an FDA rejection is the end of the regulatory road for an experimental drug. With Tuesday’s approval of Xphozah, Ardelyx is the rare company to overcome such a hurdle, some two years after it received a complete response letter from the agency in July 2021.
“It’s been a long, sometimes arduous path to this day,” said Ardelyx’s Chief Development Officer David Rosenbaum, who worked on Xphozah for the past 13 years, on a call with investors Wednesday morning.
