Bloomberg Law
Free Newsletter Sign Up
Login
BROWSE
Bloomberg Law
Welcome
Login
Advanced Search Go
Free Newsletter Sign Up

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

March 30, 2022, 6:31 PM

(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 ...