Ardelyx approval odds ‘very high’ after FDA grants appeal, says Piper

Piper Sandler analyst Christopher Raymond keeps an Overweight rating on Ardelyx with an $8 price target after the FDA granted the appeal to the Complete Response Letter for Xphozah. The appeal grant comes with FDA’s direction for the company to work with the Division of Cardiology and Nephrology to develop an appropriate label, which the company believes could be directed at patients whose hyperphosphatemia is insufficiently managed on phosphate binders, Raymond tells investors in a research note. He believes the likelihood of Xphozah getting approved are "very high after today’s decision." Raymond continues to like the stock’s risk/reward, saying it is "heavily positively skewed at this point." Shares of Ardelyx are down 11% to $2.33 in early trading.