Business
Akebia Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights
Akebia to host conference call at 8:00 a.m. ET Vadadustat NDA assigned a PDUFA date of March 27, 2024Vadadustat approved in 36 countries, including Australia
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"Akebia to host conference call at 8:00 a.m. ET\nVadadustat NDA assigned a PDUFA date of March 27, 2024Vadadustat approved in 36 countries, including Australia and TaiwanAkebia strengthens cash position modifying Pharmakon loanAuryxia® (ferric citrate) quarterly net product revenue of $40.1 millionCAMBRIDGE, Mass., Nov. 8, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today reported financial results for the third quarter ended September 30, 2023 and reviewed recent business highlights.\n\n \n \n \n \n \n \n\n \nIn September, Akebia completed its resubmission to its New Drug Application for vadadustat to the U.S. Food and Drug Administration (FDA) as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis. FDA subsequently accepted the resubmission and assigned a user fee goal date (\"PDUFA date\") of March 27, 2024. The resubmission includes post-marketing safety data from tens of thousands of patients in Japan where vadadustat is approved and has been in the market for more than three years.\n\"Akebia is extremely well-positioned following the acceptance of our vadadustat NDA resubmission, with a March 27, 2024 PDUFA date,\" said John P. Butler, Chief Executive Officer of Akebia. \"We are preparing for a commercial launch if vadadustat is approved and stand ready with a commercial team in place and product supply on the shelf. We also added Australia and Taiwan to the list of countries where vadadustat is approved for CKD patients on dialysis. Additionally, we have strengthened our financial position by deferring our Pharmakon principal payments until October 2024.\"\nAuryxia® (ferric citrate) net product revenue for the third quarter was $40.1 million and management reaffirms previously issued 2023 net product revenue guidance of $170.0 - $175.0 million for Auryxia.\nThird Quarter 2023 and Recent Business Highlights\nAustralia's Therapeutic Goods Administration granted approval for Vafseo® (vadadustat) for the treatment of anemia associated with CKD in adults on chronic maintenance dialysis. Vadadustat was also authorized for use in Taiwan during this time, marking approval in 36 countries.Akebia supported five posters presented at the American Society of Nephrology Kidney We...