With a 9-4 vote, the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee bucked FDA reviewers who delayed PDUFA dates, issued a complete response letter and two formal dispute resolution requests for Ardelyx Inc.’s tenapanor as a hyperphosphatemia therapy for adults on dialysis with chronic kidney disease (CKD).

Ardelyx Inc. could have a rocky row to hoe when it makes its case for tenapanor, as a hyperphosphatemia therapy in adults with chronic kidney disease, before the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee Nov. 16. The big question facing the adcom is whether the change in baseline serum phosphorous levels achieved by the drug is clinically meaningful. Clearly, FDA reviewers don’t think so, as that question already has resulted in delayed PDUFA dates, a complete response letter and two formal dispute resolution requests.

New research presented by the University of Michigan revealed groundbreaking results for Certa Therapeutics Pty Ltd.’s lead candidate, FT-011, for serious inflammatory and fibrotic diseases.

New and updated preclinical and clinical data presented by biopharma firms at the American Society of Nephrology Kidney Week including: Boehringer, Chinook, Eli Lilly, Horizon, Ionis, Lexicon, Vera.

New and updated preclinical and clinical data presented by biopharma firms at the American Society of Nephrology Kidney Week including: Alpine Immune, Ionis, Kezar, Valenzabio, Xortx.

New research presented by the University of Michigan revealed groundbreaking results for Certa Therapeutics Pty Ltd.’s lead candidate, FT-011, for serious inflammatory and fibrotic diseases. The results of a chronic kidney disease study presented at the American Society of Nephrology meeting on Nov. 4 concluded that FT-011 reverses the activation of molecular markers associated with fibrosis.