Ardelyx Inc saw its value soar today after the US Food and Drug Administration's (FDA) advisory panel recommended the approval of the group’s drug for chronic kidney disease patients on dialysis, more than a year after it was initially rejected.
The panel voted 9-4 in favor of the drug, Xphozah (tenapanor), to be administered as a single therapy for treating high phosphate levels in the blood of patients on dialysis.
The advisers also voted 10-2 in favor of the drug's use alongside existing treatment.
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The market warmed to the news, sending its shares 43.44% higher to US$1.75.
Xphozah is an oral drug that reduces the level of phosphate in the body by targeting the pathway that absorbs it.
Currently, phosphate binders are the only approved therapy for hyperphosphatemia, a condition resulting in abnormally high levels of phosphorus in the blood, which is a sign of kidney damage.
Around 37 million people, or one in seven, in the US have chronic kidney disease, as per a government report last year.
"Today's vote….is a promising development for the chronic kidney disease community” said Mike Raab, president and chief executive officer of Ardelyx.
Raab was also optimistic about the FDA deciding on similar lines as the panel's vote.
The FDA, which usually follows the recommendations of its expert panel, is expected to make its final decision on the drug within 30 days of the conclusion of the panel meeting.
"We are confident that the data from three Phase 3 clinical trials involving more than 1,200 patients support the approval of Xphozah in the US for the control of serum phosphorus in adult patients with CKD on dialysis” he said.
Sharon Moe, MD, chief of the division of nephrology and hypertension, Indiana University School of Medicine, added, "Xphozah is a novel treatment that provides a clinically meaningful effect on serum phosphate. I am encouraged by the committee's vote.”
Contact the author at jeremy@proactiveinvestors.com