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Ardelyx stock craters as FDA slaps biotech with dreaded ‘deficiencies’ tag on kidney drug

July 20, 2021


Shares in Ardelyx are in freefall after the FDA found a series of “deficiencies” with Ardelyx’ application for the kidney disease hopeful tenapanor.

In what CEO Mike Raab said was an “extremely disheartening and disappointing communication from the FDA,” the U.S. regulator, which has already delayed the decision date for the therapy once to the end of the month, is now heaping more pressure on the med.

Specifics were not shared by the FDA, but according to Ardelyx (the FDA doesn’t release the information publicly), the deficiencies that led to the red light were related to a “key issue” which was the size of the treatment effect and its clinical relevance: i.e., whether it actually works.

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