Form 8-K ARDELYX, INC. For: Jul 13
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Ardelyx's (ARDX) Shares Plunge as Tenapanor's Deficiencies Identified by FDA 'Take Approval Off the Table'
July 20, 2021 9:57 AM EDTOn July 19th, 2021, Ardelyx, Inc (NASDAQ: ARDX) disclosed a letter from the US Food and Drug Administration (FDA) relating to its New Drug application for Tenapanor the companys drug candidate for the control of serum phosphorus in adult patients with chronic kidney disease (CKD).
The agency notified the company of identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time, as well as denied a follow-up meeting request by ARDX.
The FDA move took the market by surprise, sending the companys... More
