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.
Ardelyx is seeking approval for XPHOZAH for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
"We view the interim response that we received from the OND as an important next step in our ongoing pursuit of approval of XPHOZAH," said Mike Raab, president and chief executive officer of Ardelyx.
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Ardelyx is a biotechnology company focused on the discovery, development and commercialization of molecule and polymeric therapeutics to treat the gastrointestinal tract and cardiorenal diseases.
According to data from Benzinga Pro, Ardelyx has a 52-week high of 9.10 and a 52-week low of $0.58.
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