Why Are Shares Of Ardelyx Ripping Higher?

Shares of Ardelyx Inc ARDX were advancing strongly on above-average volume Tuesday following a clinical trial readout from the company.

What Happened

Ardelyx announced positive results from a pivotal Phase 3 study dubbed AMPLIFY that evaluated its lead asset tenapanor in combination with phosphate binders in patients with chronic kidney disease on dialysis, whose hyperphosphatemia, or elevated phosphate levels in blood, was not previously controlled with binders alone.

The company said the study met the primary endpoint and all key secondary endpoints, including showing a statistically significant reduction in serum phosphate levels in patients treated with tenapanor and phosphate binders compared to phosphate binders alone.

Why It's Important

High phosphate levels of over 5.5 mg/dL are associated with increased mortality.

"Faced with an extremely high mortality rate of approximately 18% per year in dialysis patients, we are very focused on managing and treating elevated serum phosphorus," Glenn Chertow, a nephrologist at the Standard University, said in a statement. 

"Elevated serum phosphorus is associated with mortality, cardiovascular events and bone fracture among patients receiving dialysis, and more than half of patients cannot achieve control of hyperphosphatemia despite taking a [fistful] of binders three times daily with meals. The AMPLIFY study results provide convincing evidence that controlling hyperphosphatemia will soon be within our reach."

What's Next

Ardelyx said it now expects to report results from its second Phase 3 monotherapy study, PHREEDOM, in the fourth quarter.

"With additional positive results from that trial, we will complete our New Drug Application for tenapanor, encompassing two indications: monotherapy and combination therapy for the treatment of hyperphosphatemia," CEO Mike Raab said in a statement.

Ardelyx shares were up 62.79% at $5.54 at the time of publication Tuesday. 

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