Akebia Therapeutics Stock Jumps as FDA Accepts Vadadustat US Application in CKD-Related Anemia

  • Akebia Therapeutics Inc AKBA and its collaborator Otsuka Holdings OTSKY have announced that the FDA has accepted to review vadadustat's marketing application for anemia due to chronic kidney disease.
  • The application covers both adult patients, on dialysis and not on dialysis.
  • The agency's target action date is March 29, 2022.
  • The FDA also indicated that they are not currently planning to hold an Advisory Committee meeting to discuss the application.
  • In addition, Otsuka is working with Akebia to prepare a Marketing Authorization Application for vadadustat for submission to the European Medicines Agency expected in 2021.
  • Price Action: AKBA shares are up 8.28% at $3.80 during the premarket session on the last check Tuesday.
Posted In: AnemiaBriefsChronic Kidney DiseaseBiotechNewsPenny StocksHealth CareSmall CapFDAGeneral