Cantor Fitzgerald raised its price target for Ardelyx (NASDAQ:ARDX) to $3 from $1.60 but maintained a “neutral” rating after a label update from the FDA. The stock closed at $2.51 on Dec. 28.
Ardelyx announced that the Office of New Drugs directed the Division of Cardiology and Nephrology to work with the company to develop a label to support the commercialization of chronic kidney disease drug, Xphozah.
Ardelyx plans to resubmit its NDA in the first half of 2023 after the FDA granted an appeal to a previously complete response letter.
Analyst Louise Chen writes that on approval, Xphozah would be the first and only phosphate absorption inhibitor, offering patients a novel mechanism.
“This is clearly good news for the company,” she said. “Although we think the company’s execution has been strong in 2022, we remain on the sidelines until earnings visibility becomes clearer in 2023-plus,” she added.
