Akebia Plunges After Vadadustat Fails to Win FDA Approval (1)

(Updates with shares in headline and first and second paragraphs and plans for a conference call.)

Akebia Therapeutics plunges as much as 72% after resuming trading as the company said the FDA has issued a complete response letter to its vadadustat new drug application, which is under review for the treatment of anemia due to chronic kidney disease.

• The stock’s fall is biggest intraday since September 2020, taking shares to lowest level on record
• The FDA concluded that the data in the NDA do not support a favorable benefit-risk assessment of vadadustat for dialysis and non-dialysis patients
  • FDA expressed safety ...