Business
Akebia Therapeutics Reports Third Quarter 2021 Financial Results and Highlights Recent Company Milestones
- Pre-commercialization activities underway in anticipation of March 29, 2022 PDUFA date - Vadadustat marketing authorization application submitted to the
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"- Pre-commercialization activities underway in anticipation of March 29, 2022 PDUFA date\n - Vadadustat marketing authorization application submitted to the European Medicines Agency\n - Continued growth of Auryxia® (ferric citrate) with net product revenue of $36.8 million\n - Company to host Conference Call on Tuesday, November 9 at 9:00 a.m. ET\n\n\nCAMBRIDGE, Mass., Nov. 4, 2021 /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, 2021 and highlighted recent corporate milestones. \n\n \n \n \n \n \n \n\n \nThe Company will host a conference call on Tuesday, November 9, 2021, at 9:00 a.m. Eastern Time. Executives will highlight publications and scientific presentations of vadadustat Phase 3 clinical data, which will be presented at American Society of Nephrology Kidney Week 2021 beginning today. The Company will also discuss ongoing pre-commercialization activities ahead of a potential first-in-class U.S. launch for vadadustat, Akebia's investigational oral therapeutic for the treatment of anemia due to chronic kidney disease (CKD). Vadadustat is currently under review by the U.S. Food and Drug Administration (FDA) with a scheduled Prescription Drug User Fee Act (PDUFA) date of March 29, 2022. \n\"We are within five months of vadadustat's PDUFA date, which has the potential to be a pivotal catalyst for the company, and, if approved, would mean the availability of a novel, oral therapeutic for people living with anemia due to chronic kidney disease,\" said John P. Butler, Chief Executive Officer, Akebia Therapeutics. \"We continue to value opportunities to share vadadustat efficacy and safety data with nephrologists through scientific congresses such as ASN Kidney Week. While our review with the FDA is ongoing, we remain confident that the data we have compiled and submitted for review makes a compelling case for approval in dialysis patients.\" \n\"Akebia has made substantial progress on pre-commercialization activities to prepare for a first-in-class product launch for vadadustat in the U.S. in 2022, subject to regulatory approval,\" added Dell Faulkingham, Chief Commercial Officer, Akebia Therapeutics. \"As part of our commercialization prepar...