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| Share Name | Share Symbol | Market | Type |
|---|---|---|---|
| Ardelyx Inc | NASDAQ:ARDX | NASDAQ | Common Stock |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 2.02 | 29.75% | 8.81 | 8.82 | 8.84 | 9.13 | 7.98 | 8.36 | 24,971,221 | 00:59:39 |
From May 2023 to May 2024
By Ben Glickman
Ardelyx has received approval from the U.S. Food and Drug Administration for tenapanor, an add-on treatment for chronic kidney disease patients on dialysis.
The Waltham, Mass.-based biopharmaceutical company said its commercial launch of tenapanor, which goes by brand name Xphozah, was underway with product expected to become available next month.
The company said tenapanor is a phosphate absorption inhibitor which can be given to patients on dialysis with chronic kidney disease who don't have adequate response to phosphate binders or who have intolerance of phosphate binder therapy.
Ardelyx's application for Xphozah was previously rejected by the FDA, but the company appealed its rejection and its resubmission was accepted in May.
The FDA approval was based on a Phase 3 trial of Xphozah which met primary and key secondary endpoints.
Write to Ben Glickman at ben.glickman@wsj.com
(END) Dow Jones Newswires
October 17, 2023 19:29 ET (23:29 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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