Ardelyx craters after FDA stuns analysts and rejects their kidney disease pitch
Three months after revealing the FDA had asked for more information to support their application for a chronic kidney disease drug, Ardelyx announced that the agency has rejected it.
The California and Massachusetts-based biotech said that the agency was concerned with how effective the drug, known as tenapanor, actually was, raising questions about the magnitude of improvement seen in the company’s Phase III trials and whether they would actually translate into a tangible benefit for CKD patients.
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