Business
Akebia Therapeutics Reports Fourth Quarter and Full-Year 2019 Financial Results and Hosts Conference Call to Discuss Recent Business Highlights
Top-line data readouts of global Phase 3 program for vadadustat on track for Q2 of 2020 and mid-2020 Company extends cash runway well into 2021 CAMBRIDGE,
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"\n\nTop-line data readouts of global Phase 3 program for vadadustat on track for Q2 of 2020 and mid-2020 \n\n\nCompany extends cash runway well into 2021\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAkebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease, today announced financial results for the fourth quarter and full-year ended December 31, 2019. The Company will host a conference call today, Tuesday, March 10, 2020, at 9:00 a.m. Eastern Time to discuss its fourth quarter and full-year 2019 financial results and recent business highlights.\n\n\n“2019 was a year of considerable progress for Akebia and with many milestones on the horizon, 2020 is shaping up to be equally, if not more, exciting,” stated John P. Butler, Chief Executive Officer of Akebia. “Our highest priority remains the successful execution of our global Phase 3 program for vadadustat, our investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). We have a tremendous amount of confidence in our vadadustat clinical program and believe we’ve developed an exciting path forward to drive significant value for all our stakeholders. We believe our ability to potentially access a Priority Review Voucher (PRV) for the vadadustat New Drug Application (NDA) to expedite FDA review would meaningfully enhance the potential of bringing vadadustat to patients as quickly as possible, subject to regulatory approval.”\n\n\nButler continued, “We look forward to sharing data from our global Phase 3 studies of vadadustat, starting with top-line data from INNO2VATE on track for the second quarter of 2020 followed by PRO2TECT in mid-2020. We expect vadadustat to be the first drug of the HIF-PHI class to deliver clear data that directly compare its outcomes to the current standard of care in dialysis-dependent and non-dialysis dependent patients for the treatment of anemia due to chronic kidney disease (CKD).”\n\n\nAgreement with Vifor Pharma regarding a Priority Review Voucher\nIn February 2020, Akebia entered into a letter agreement with Vifor (International) Ltd. (Vifor Pharma) relating to Vifor Pharma’s agreement with a third party to purchase a PRV issued by the U.S. Food and Drug Administration (FDA), subject to satisfaction of customary cl...