Ardelyx Inc

NASDAQ:ARDX   10:06:36 AM EDT
1.61
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Products, Regulatory

Ardelyx Provides Regulatory Update On New Drug Application For Tenapanor For The Control Of Serum Phosphorus In Adult Patients With Ckd On Dialysis

Published: 07/19/2021 20:12 GMT
Ardelyx Inc (ARDX) - Ardelyx Provides Regulatory Update on New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients With Ckd on Dialysis.
Ardelyx -received Letter From FDA Stating As Part of Ongoing Review of Co's NDA for Control of Serum Phosphorus in Adult Patients With Ckd on Dialysis.
Ardelyx - in Letter, FDA Has Identified Deficiencies That Preclude Discussion of Labeling and Post-marketing Requirements/commitments at This Time.
Ardelyx Inc - FDA Letter Stated That Notification Does Not Reflect a Final Decision on Information Under Review.
Ardelyx Inc - Immediately Requested Meeting With FDA to Discuss Deficiencies and Was Notified That Request for Meeting Was Denied.
Ardelyx - While FDA Has Not Provided Specific Details Regarding Deficiencies, FDA Noted That Key Issue is Size of Treatment Effect, Clinical Relevance.