Ardelyx (ARDX) Up on Xphozah's Orphan Tag for Hyperphosphatemia
Ardelyx, Inc. ARDX announced that the FDA has 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 through its primary pathway.
Hyperphosphatemia is a serious condition resulting in an elevated level of phosphate in the blood, which affects most chronic kidney disease (CKD) patients on maintenance dialysis. Per ARDX, approximately 550,000 patients in the United States suffer from CKD.
The orphan drug designation will grant Ardelyx market exclusivity for Xphozah for a predefined time period in the above indication, along with the exemption of FDA application fees and tax credits for qualified clinical studies, all subject to approval. This designation is granted to support the development of medicines 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. Year to date, shares of Ardelyx have shot up 41.4% against the industry’s 13.5% fall.
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Xphozah was approved in October 2023 as an add-on therapy for the treatment of adult patients with CKD who have an inadequate response to phosphate binders or are intolerant of any dose of phosphate binder therapy.
Ardelyx’s Xphozah is the first and only phosphate absorption inhibitor that is indicated to reduce 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 twice-daily 50 mg oral pill that inhibits the sodium-hydrogen exchanger in the gastrointestinal tract, resulting in an increase in bowel movements and a decrease in abdominal pain for 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).
Some better-ranked stocks worth mentioning are Ligand Pharmaceuticals LGND, Acadia Pharmaceuticals ACAD and Anixa Biosciences ANIX. While LGND sports a Zacks Rank #1 (Strong Buy), ACAD and ANIX carry a Zacks Rank #2 (Buy) each at present.
You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2023 earnings per share has remained constant at $5.10. During the same time frame, the estimate for Ligand’s 2024 earnings per share has remained constant at $4.59. Year to date, shares of LGND have lost 14.5%.
LGND’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 67.19%.
In the past 30 days, the Zacks Consensus Estimate for Acadia’s 2023 loss per share has narrowed from 37 cents to 34 cents. The estimate for Acadia’s 2024 earnings per share is pegged at 90 cents. Year to date, shares of ACAD have gained 38.6%.
ACAD beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average earnings surprise of 20.69%.
In the past 30 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has remained constant at 32 cents. During the same time frame, the estimate for Anixa Biosciences’ 2024 loss per share has remained constant at 37 cents. Year to date, shares of ANIX have lost 32.2%.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 26.29%.
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