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Latest From Ardelyx Inc.
Tenapanor could be an option for dialysis patients who cannot tolerate phosphate binder therapy or who need more help in reaching their serum phosphorous targets, advisory committee members said; Office of New Drugs director Peter Stein is expected to rule on Ardelyx’s appeal of a complete response letter within 30 days.
Agency previously declined to approved tenapanor for the control of serum phosphorous levels in chronic kidney disease patients on dialysis, saying the magnitude of treatment effect on a surrogate endpoint in three clinical trials was less than that observed with approved drugs and of unclear significance.
The prototypical US FDA advisory committee review of a pending new drug application has become something of an endangered species. A suddenly busy October and November agenda suggests that might be changing.
ARCH closed a $3bn VC fund to end the month of June while in the same week six public biopharma firms said they are cutting jobs. Even so, some publicly traded companies have been able to launch sizeable offerings, including a $450m note sale by Cytokinetics and Xenon’s $250m follow-on.