Ardelyx Stock Collapses After FDA Rejects Its Kidney Disease Candidate Pitch


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  • Three months after revealing that the FDA had asked for more information to support tenapanor application for a chronic kidney disease drug, the FDA issued a letter to Ardelyx Inc (NASDAQ: ARDXidentifying deficiencies in its application ahead of its PDUFA date next week (July 29).
  • The Company, which got word from the FDA on July 13, said they asked for a meeting with the agency to discuss the rejection and fix any shortcomings but were turned down.
  • The agency noted that a key issue is the size of the treatment effect and the clinical relevance of tenapanor for controlling serum phosphorus in adult patients with chronic kidney disease on dialysis.
  • CEO Mike Raab expressed surprise at the decision, noting that the drug had hit its primary endpoint in three pivotal trials across 1,000 patients. 
  • The FDA in 2019 approved 50 mg, twice-daily oral tenapanor to increase bowel movements and decrease abdominal pain for patients with irritable bowel syndrome with constipation.
  • In April, FDA had asked Ardelyx to provide information on how the drug’s mechanism of action works.
  • Price Action: ARDX shares cratered 67.1% at $2.53 during the premarket session on the last check Tuesday.
  • Related content: Benzinga's Full FDA Calendar.

27% profit every 20 days?

This is what Nic Chahine averages with his option buys. Not selling covered calls or spreads… BUYING options. Most traders don’t even have a winning percentage of 27% buying options. He has an 83% win rate. Here’s how he does it.


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Posted In: BiotechNewsHealth CareSmall CapFDAGeneralBriefsChronic Kidney Disease