Ardelyx, Inc. ARDX announced that the FDA granted orphan drug designation to Xphozah (tenapanor) for the treatment of pediatric hyperphosphatemia. Xphozah is Ardelyx’s twice-daily oral tablet with a novel mechanism of action that blocks phosphate absorption via its primary pathway.
Hyperphosphatemia is a serious condition resulting in elevated blood phosphate levels that affects most patients with chronic kidney disease (CKD) undergoing dialysis. According to ARDX, approximately 550,000 patients in the United States are affected by CKD.
Orphan drug designation will grant Ardelyx market exclusivity for Xphozah for a pre-specified period in the above indication, as well as exemption from FDA application fees and tax credits for qualified clinical studies, all subject to approval. This designation is given to support drug development for rare disorders that affect fewer than 200,000 patients in the United States.
The company’s stock rose 4.1% on Thursday in response to the encouraging news. Ardelyx shares are up 41.4% year-to-date, versus a 13.5% decline for the industry.
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Xphozah was approved in October 2023 as add-on therapy for the treatment of adult patients with CKD who have an inadequate response to phosphate binders or are intolerant to any dose of phosphate binder therapy.
Ardelyx’s Xphozah is the first and only phosphate reabsorption inhibitor indicated for the reduction of serum phosphorus in adult CKD patients on dialysis.
Xphozah is Ardelyx’s second FDA-approved drug. Ardelyx’s first commercial product, Ibsrela (tenapanor), received FDA approval in September 2019 for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
Ibsrela is a 50 mg twice-daily oral pill that inhibits the sodium-hydrogen exchanger in the gastrointestinal tract, leading to increased bowel movements and decreased abdominal pain in IBS-C patients.
Ardelyx, Inc. Price and consensus
Ardelyx, Inc. price-consensus-chart |: Ardelyx, Inc. Quote:
Zacks Rank and stocks to consider
Ardelyx currently has a Zacks Rank #3 (Hold).
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