U.S. Food and Drug Administration staff reviewers on Monday raised concerns over unclear benefits of Ardelyx Inc's drug for kidney disease patients, but the company's shares rose 20% on expectations over a possible approval.
Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly
drug for kidney disease patients, but the company's shares rose 20% on expectations over a possible approval. However, the concerns were in line with expectations, said Citi analysts, adding that the documents set the tone for a positive discussion when the FDA's outside advisers meet on Wednesday to weigh data on the drug.
Ardelyx's oral drug, tenapanor, is aimed at reducing elevated blood phosphate levels in patients with chronic kidney disease .in 2015 for $25 million, and developed it alone following troubles with the drug's initial trials.the FDA following Ardelyx's appeal against the regulator's initial rejection of the drug in July last year, after it identified deficiencies.
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