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 that results in a high level of phosphate in the blood, which affects the majority of chronic kidney disease (CKD) patients on maintenance dialysis. According to ARDX, approximately 550,000 patients in the United States suffer from CKD.
Orphan drug designation will grant Ardelyx market exclusivity for Xphozah for a predefined time period as indicated above, along with exemption from 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 shares rose 4.1% on Thursday in response to the encouraging news. Year to date, Ardelyx shares are up 41.4% against the industry’s 13.5% fall.
Image Source: Zacks Investment Research
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 who are intolerant to any dose of phosphate therapy.
Ardelyx’s Xphozah is the first and only phosphate absorption inhibitor indicated to reduce serum phosphorus in adult CKD patients on dialysis.
Xphozah is Ardelyx’s second drug approved by the FDA. 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 sodium-hydrogen exchange in the gastrointestinal tract, resulting in increased bowel movements and decreased abdominal pain for IBS-C patients.
The price and consent of Ardelyx, Inc
The price of Ardelyx, Inc. Quotation of Ardelyx, Inc
Zacks Rank and Stocks to Consider
Ardelyx currently has a Zacks Rank #3 (Hold).
Some top rated stocks worth mentioning are Ligand Pharmaceuticals LGND, Acadia Pharmaceuticals ACAD is Anixa Biosciences ANIX. While LGND sports a Zacks Rank #1 (Strong Buy), ACAD and ANIX carry a Zacks Rank #2 (Buy) each at the moment.
You can see the full list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, the Zacks Consensus Estimate for Ligand’s 2023 earnings per share has been flat at $5.10. During the same period, Ligand’s 2024 earnings per share estimate was flat at $4.59. Year to date, LGND shares have lost 14.5%.
LGND’s earnings beat estimates in each of the past four quarters, delivering an average surprise of 67.19%.
Over the past 30 days, the Zacks Consensus Estimate for Acadia’s 2023 EPS narrowed from 37 cents to 34 cents. Acadia’s earnings per share estimate in 2024 is set at 90 cents. Year to date, ACAD shares have gained 38.6%.
ACAD beat estimates in two of the four quarters, missing the mark on the other two occasions, delivering an average earnings surprise of 20.69%.
Over the past 30 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 earnings per share has been flat at 32 cents. During the same period, the estimate of the loss per share of Anixa Biosciences 2024 was constant at 37 cents. Year to date, ANIX shares have lost 32.2%.
ANIX beat estimates in each of the last four quarters, delivering an average earnings surprise of 26.29%.
Want the latest advice from Zacks Investment Research? Today, you can download 7 Best Stocks for the next 30 days. Click to get this free report
Ligand Pharmaceuticals Incorporated (LGND): Free Stock Analysis Report
ACADIA Pharmaceuticals Inc. (ACAD) shows a free financial report
A financial report on the income of Ardelyx, Inc. (ARDX).
The financial report on the income of ANIXA BIOSCIENCES INC
To read this article on Zacks.com click here.
Zacks Investment Research
#Ardelyx #ARDX #Xphozahs #Orphan #Tag #Hyperphosphatemia
Image Source : finance.yahoo.com