Ardelyx (ARDX) Up on Xphozah’s Orphan Tag for Hyperphosphatemia

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 and consensusArdelyx, Inc.  Price and consensus

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 rated stocks are worth mentioning Ligand Pharmaceuticals: LGND, Acadia Pharmaceuticals ACAD and: Anixa Biosciences ANIX: While LGND has a Zacks Rank #1 (Strong Buy), ACAD and ANIX currently have a Zacks Rank #2 (Buy) each.

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 remained unchanged at $5.10. In the same period, Ligand’s 2024 EPS estimate was unchanged at $4.59. LGND shares have lost 14.5% year to date.

LGND’s earnings have beaten estimates in each of the last four quarters, delivering an average surprise of 67.19%.

Over the past 30 days, the Zacks Consensus Estimate for Acadia’s 2023 earnings per share was cut to 34 cents from 37 cents. Acadia’s 2024 EPS estimate is 90 cents. ACAD shares are up 38.6% year to date.

ACAD has beaten estimates in two of the last four quarters, missing the mark the other two times, delivering an average earnings surprise of 20.69%.

Over the past 30 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share was flat at 32 cents. Anixa Biosciences’ 2024 loss per share estimate for the same period was unchanged at 37 cents. ANIX shares have lost 32.2% year to date.

ANIX beat estimates in each of the last four quarters, delivering an average earnings surprise of 26.29%.

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