
Ardelyx Inc (NASDAQ:ARDX) shares are trading higher by 29.32% at $0.97 after the company reported it received an interim response from the OND, CDER and FDA for the company’s second level of appeal of the Complete Response Letter for XPHOZAH.
Ardelyx says the OND intends to direct the Division of Cardiology and Nephrology to bring the XPHOZAH New Drug Application (NDA) to the Cardiovascular and Renal Drugs Advisory Committee, and to provide a response to Ardelyx's appeal within thirty (30) days after the conclusion of the Advisory Committee meeting.