The Ardelyx Inc (NASDAQ: ARDX) stock price soared 59.4% after the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) recommended that the regulator approves the company’s chronic kidney disease treatment known as Xphozah.
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The cancer drug controls the serum phosphorus in adult patients suffering from chronic kidney disease who are currently on dialysis. Xphozah is administered as a monotherapy, with its side effects far outweighing its benefits.
The advisory panel voted 9-4 in favour of the drug’s approval, which is marketed as tenapanor and can treat high phosphate levels in dialysis patients’ blood. Investors reacted positively to the announcement, which could unlock a new revenue stream for Ardelyx Inc if the FDA acts on the recommendation and approves the drug.
However, there are no guarantees that the FDA’s Office of New Drugs, Center for Drug Evaluation and Research will approve the drug after Ardelyx filed a second-level appeal of the Complete Response Letter received on July 28, 2021, for Xphozah.
The Office for New Drugs (OND) will respond to Ardelyx’s appeal within thirty days after the recent vote in favour of Xphozah’s approval. The vote was called after Ardelyx filed an appeal following the FDA’s rejection of the drug.
The FDA’s staff reviewers rejected the drug, saying its benefits are unclear. While the panel agreed with some of the FDA’s concerns, some members highlighted that while the drug might not cure kidney disease, it can help alleviate some adverse side effects of dialysis.
The panel member added that, at the moment, the symptoms were being left untreated; hence, it is better to have a drug targeting the effects than to have no treatment, as is the case now. Ardelyx’s CEO, Mike Raab, was optimistic that the FDA’s ruling would align with the panel’.
Analysts at Piper Sandler rushed to upgrade Ardekyx from neutral to overweight following the panel’s vote outcome. Today’s rally is evidence of the market’s positive expectations regarding the drug’s approval.
*This is not investment advice.
Ardelyx stock price.
The Arldelyx stock price soared 59.43% to trade at $1.95, rising from Wednesday’s closing price of $1.22.