Ardelyx stock rockets on heavy volume after positive FDA panel vote on kidney disease treatment

Shares of Ardelyx Inc.
ARDX,
+35.66%
rocketed 75.4% on heavy volume toward a 16-month high in premarket trading Thursday, after an advisory panel of the U.S. Food and Drug Administration voted that benefits of the biopharmaceutical company’s treatment for chronic kidney disease (CKD) on dialysis, XPHOZAH, outweigh the risks. Trading volume was 11.7 million shares ahead of the open, compared with the full-day average of 4.3 million shares. That made Ardelyx’s stock the biggest gainer and most active in the premarket. The panel’s vote comes after Ardelyx had appealed the FDA Complete Response Letter (CRL) received in July 2021 regarding the New Drug Application (NDA) for its CKD treatment. “We are hopeful following today’s discussion that the data, the opinion of the advisory committee, the needs of patients, and the compelling voice of the broader nephrology community will be reflected in the FDA’s decision on our appeal,” said Ardelyx Chief Executive Mike Raab. The stock had already rallied 13.0% over the past three months through Wednesday, while the iShares Biotechnology ETF
IBB,
-1.59%
has gained 2.9% and the S&P 500
SPX,
-1.21%
has lost 7.4%.