Ardea and FDA reach an agreement on gout drug
Earlier on Wednesday, Ardea Biosciences Inc. announced that it reached an agreement with the US Food and Drug Administration regarding a late-stage clinical trial for lesinurad, following which the company shares increased.
Both the company and the agency reached a common consensus regarding the size and design of the studies, the main study objectives, manufacturing plans, and the safety databases. Following this meeting, it is very likely that the drug will receive FDA approval, provided lesinurad achieves its study endpoints.
Lesinurad, intended to treat gout, is the company’s most advanced drug candidate.
On Wednesday, Ardea shares jumped $1.03, or 6.7 percent, to $16.49, although the stock remained unchanged in aftermarket trading.