Ardelyx Shares Rally Premarket on FDA Approval of Xphozah
By Colin Kellaher
Shares of Ardelyx rose sharply in premarket trading Wednesday after the biopharmaceutical company finally won U.S. Food and Drug Administration approval of its Xphozah drug for kidney disease.
After the closing bell on Tuesday, the Waltham, Mass., biopharmaceutical company said the FDA approved Xphozah to reduce serum phosphorus in adults with chronic kidney disease who are on dialysis.
The FDA in 2021 rejected Ardelyx's initial application for approval of Xphozah, but the company appealed, and an FDA advisory committee late last year voted that the drug's benefits outweigh its risks, and the agency in May accepted Ardelyx's resubmitted application for Xphozah.
Ardelyx said the commercial launch for Xphozah is underway, with the drug expected to be available next month.
Ardelyx shares, which closed Tuesday at $3.45, were recently up more than 16% to $4.02 in premarket trading.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 18, 2023 08:15 ET (12:15 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
These Stocks Are (Still) Powering the Bull Market
-
5 Undervalued Energy Stocks to Play the AI Data Center Demand Boom
-
After Earnings, Is Lowe’s Stock a Buy, Sell, or Fairly Valued?
-
5 Stocks With the Largest Fair Value Estimate Cuts After Q1 Earnings
-
10 Stocks With the Largest Fair Value Estimate Increases After Q1 Earnings
-
Markets Brief: Inflation Back in the Spotlight
-
AI Is Booming, but Consumer Spending Is Slowing. Which Will Prevail in the Stock Market?
-
What’s Happening In the Markets This Week
-
3 Dividend Stocks for June 2024
-
After Earnings, Is Alibaba Stock a Buy, Sell, or Fairly Valued?
-
MongoDB Earnings: Slashing Valuation as Execution and Macro to Blame for Lower Guidance
-
Marvell Earnings: We Raise Our Medium-Term AI Forecast and Bring Our Valuation Up to $75
-
Zscaler Earnings: Impressive Traction in Emerging Products Drives Sales Growth for the Quarter
-
Dell Earnings: Raising Valuation on Strong AI, but the Stock Remains Severely Overvalued
-
After Earnings, Is Nvidia Stock a Buy, Sell, or Fairly Valued?
-
The 10 Best Companies to Invest in Now