The FDA decision on Akebia Therapeutics Inc.’s (AKBA) resubmitted New Drug Application for Vadadustat is due on March 27, 2024.Vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability, is proposed for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.This is the company’s second attempt to secure FDA approval for Vadadustat.In its first attempt, i.e., in March 2022, the company had sought approval of Vadadustat for the treatment of anemia due to chronic kidney disease in both adult patients on dialysis and adult patients not on dialysis.The U.S. regulatory agency declined to approve Vadadustat then, saying that the application did not support a favorable benefit-risk assessment of Vadadustat for dialysis and non-dialysis patients. Later in May 2023, the FDA provided a path forward for the company to resubmit the new drug application (NDA) for Vadadustat for the treatment of anemia due to chronic kidney disease for dialysis dependent patients. Following multiple discussions with the FDA, the company resubmitted its New Drug Application for Vadadustat, seeking approval for treating anemia due to chronic kidney disease in adult patients on dialysis, which awaits a decision on the above-said date (March 27, 2024). Vadadustat is approved in 36 countries, including Europe and Australia, for the treatment of symptomatic anemia due to CKD in adult patients on chronic maintenance dialysis and in Japan as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis-dependent adult patients.AKBA closed Tuesday's (Feb.27, 2024) trading at $1.64, up 8.61%.