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

Author: Vandana Singh | June 01, 2021 08:58am

• Akebia Therapeutics Inc (NASDAQ:AKBA) and its collaborator Otsuka Holdings (OTC: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: AKBA OTSKY