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.