Business
Akebia Therapeutics Reports Third Quarter 2022 Financial Results and Recent Business Highlights
Akebia to host conference call on November 3 at 4:30 p.m. ET Filed Formal Dispute Resolution Request related to the CRL for vadadustatReported Auryxia®
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"Akebia to host conference call on November 3 at 4:30 p.m. ET \nFiled Formal Dispute Resolution Request related to the CRL for vadadustatReported Auryxia® (ferric citrate) quarterly net product revenue of $42.2, an increase of 14.9% over Q3 2021Affirmed 2022 Auryxia net product revenue guidance of $170 - $175MManaged operating expenses in support of three strategic pillarsCAMBRIDGE, Mass., Nov. 3, 2022 /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, 2022 and provided business highlights.\n\n \n \n \n \n \n \n\n \n\"Our team continues to execute a strategy aligned with our three strategic pillars, drive Auryxia revenue while managing costs, support the regulatory processes for vadadustat globally, and thoughtfully invest in our pipeline,\" said John P. Butler, Chief Executive Officer of Akebia. \"Our team is leading the regulatory review of vadadustat in Europe and select ACCESS markets. Between those review processes and the submission of a request for formal dispute resolution with the FDA regarding the Complete Response Letter for vadadustat in the U.S., we anticipate the fourth quarter could bring some clarity and a timeframe for our ability to potentially obtain approval for vadadustat in various markets.\" \nIn October 2022, Akebia submitted a Formal Dispute Resolution Request (FDRR) with the U.S. Food & Drug Administration (FDA) regarding the Complete Response Letter (CRL) received in March 2022 for vadadustat, which was under review as a treatment for anemia due to chronic kidney disease (CKD). The FDRR focuses on the favorable balance of the benefits and risks of vadadustat for the treatment of anemia due to CKD in adult patients on dialysis in light of safety concerns expressed by the FDA in the CRL related to the rate of adjudicated thromboembolic events driven by vascular access thrombosis for vadadustat compared to the active comparator and the risk of drug-induced liver injury. Based on the typical FDRR process, Akebia expects to receive a response to its submission by the end of 2022.\n\"We act in the interest of patients impacted by kidney disease and believe in the favorable balance of the benefits and risks of vadadustat as a t...