The company had a type A meeting with the agency on its NDA for tenapanor for the control of serum phosphorus in chronic kidney disease but says it was not provided with clarity of what constitutes magnitude of treatment effect.
The plan will incur restructuring charges of ~$2.3M and be recorded mostly in Q4. It is expected to complete in December.
Ardelyx said that the staff reduction will save ~$18.1M.