FDA accepts Akebia's resubmitted NDA for vadadustat; PDUFA date March 27, 2024

Akebia Therapeutics, Inc.

Resubmission classified as class 2 response; six-month review period from resubmission date.
Post-marketing safety data from tens of thousands of Japanese patients included in the filing.
Vadadustat currently approved in 35 countries; Akebia preparing for commercial launch in H2 2024 if approved.
PDUFA goal date of March 27, 2024; resubmission addressed issues from prior complete response letter.
CEO expects availability shortly after approval, offering an oral alternative for anemia in dialysis patients.

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