Benzinga | Jun 1, 2021 08:58AM EDT

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

* 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.