Ardelyx approval for tenapanor ‘still far from a slam dunk,’ says Wedbush

After Ardelyx disclosed that FDA’s Office of New Drugs has issued an Appeal Granted Letter in its formal dispute resolution request after the company previously received a Complete Response Letter for tenapanor in hyperphosphatemia, Wedbush analyst Laura Chico said there are more regulatory hurdles to cross. While this opens a path forward for tenapanor and represents "a much-needed win" for Ardelyx, approval is "still far from a slam dunk," Chico tells investors. She awaits greater clarity on potential labeling and populations before layering in the tenapanor in hyperphosphatemia opportunity to her estimates and maintains a Neutral rating on Ardelyx shares with a $2 price target.