Business
Akebia Announced Positive Top-Line Results from Global Phase 3 Program of Vadadustat for Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis; Reports First Quarter 2020 Financial Results
- Vadadustat achieves primary efficacy and cardiovascular safety endpoints - Company's cash runway extends well into 2021 - Company to host conference call
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"- Vadadustat achieves primary efficacy and cardiovascular safety endpoints\n - Company's cash runway extends well into 2021\n - Company to host conference call today at 8:30 a.m. ET to discuss top-line data and its first quarter results\n\n\nCAMBRIDGE, Mass., May 5, 2020 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), today announced positive top-line results from INNO2VATE, its global Phase 3 cardiovascular outcomes program evaluating the efficacy and safety of vadadustat, its investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), versus darbepoetin alfa for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. (Please refer to Akebia's INNO2VATE Data Announcement for the top-line data.) The Company also reported financial results for the first quarter ended March 31, 2020 and will host a conference call with slides today, Tuesday, May 5, 2020, at 8:30 a.m. Eastern Time to discuss INNO2VATE top-line data, its first quarter financial results and recent business highlights.\n\n \n \n \n \n \n \n\n \n\"We are very excited about the positive top-line results from INNO2VATE and expect to build on this momentum with many potentially transformational near-term milestones,\" said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. \"We believe we've developed an exciting path forward for vadadustat and although the COVID-19 environment remains unpredictable, we continue to execute and deliver solid progress against these initiatives. In collaboration with our partner, Mitsubishi Tanabe, we are advancing key pre-commercial activities in support of the first regulatory approval of vadadustat expected in Japan this year. We have also significantly advanced PRO2TECT, our global Phase 3 studies evaluating the safety and efficacy of vadadustat in adult patients not on dialysis with anemia due to CKD, and expect to report top-line data from these studies mid-year, as planned. In addition, we reinforced our intellectual property position for vadadustat, confirming the path for Akebia and our collaboration partner, Otsuka, to launch vadadustat in the U.K. and potentially the rest of Europe, upon approval.\"\n\"Akebia continues to provide and support our innovative therapies, which are critical to the care of adult patients with CKD, who are a...