Ardelik, Inc. ARDX announced that the FDA granted orphan designation to Xphozah (tenapanor) for the treatment of hyperphosphatemia in children. Xphozah is an Ardelix 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 elevated blood phosphate levels that affects most patients with chronic kidney disease (CKD) on maintenance dialysis. According to ARDX, approximately 550,000 patients in the United States suffer from CKD.
Orphan drug designation will grant Ardelik market exclusivity for Xphozah for a pre-defined period of time in the above indications, along with an exemption from FDA filing fees and tax credits for qualified clinical studies, all subject to approval. This designation is awarded to support drug development 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, Ardelik shares are up 41.4% versus the industry’s decline of 13.5%.
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Xphozah was approved in October 2023 as adjunctive 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.
Ardelix Xphozah is the first and only phosphate absorption inhibitor indicated for the reduction of serum phosphorus in adult CKD patients on dialysis.
Xphozah is Ardelik’s second FDA-approved drug. Ardelik’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 patients with IBS-C.
Ardelik, Inc. Price and consensus
Ardelik, Inc. price-consensus-graph | Ardelik, Inc
Zacks Rank and Stocks to Consider
Ardelik currently has a Zacks Rank #3 (Hold).
Some higher ranked stocks worth mentioning are Ligand Pharmaceuticals LGND, Acadia Pharmaceuticals ACAD and Anika Biosciences ANIX. While LGND has a Zacks Rank #1 (Strong Buy), ACAD and ANIKS currently have a Zacks Rank #2 (Buy).
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 constant at $5.10. During the same time frame, Ligands 2024 EPS estimate remained constant at $4.59. Year to date, LGND shares have lost 14.5%.
LGND’s earnings beat 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 decreased from 37 cents to 34 cents. The estimate for Acadias 2024 earnings per share is pegged at 90 cents. Year to date, ACAD shares are up 38.6%.
ACAD has beaten estimates in two of the last four quarters, missing the other two, delivering an average earnings surprise of 20.69%.
Over the past 30 days, the Zacks Consensus Estimate for Anika Biosciences’ 2023 EPS has remained flat at 32 cents. During the same time frame, the estimate for Anika Biosciences 2024 loss per share remained constant at 37 cents. Year to date, ANIKS shares have lost 32.2%.
ANIX has beaten estimates in each of the last four quarters, delivering an average earnings surprise of 26.29%.
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