Business
Akebia Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Highlights
Potential vadadustat U.S. approval on PDUFA date of March 27, 2024 Strengthened balance sheet with $55.0 million term loan financing and $26.0 million in
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"Potential vadadustat U.S. approval on PDUFA date of March 27, 2024\nStrengthened balance sheet with $55.0 million term loan financing and $26.0 million in proceeds from ATM\nReported 2023 Auryxia (ferric citrate) net product revenue of $170.3 million\nCAMBRIDGE, Mass., March 14, 2024 /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 fourth quarter and full year ended December 31, 2023 and recent business highlights. Akebia is preparing for a potential launch of vadadustat, which is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of March 27, 2024.\n\n \n \n \n \n \n \n\n \n\"We are eagerly awaiting the PDUFA date for vadadustat, now within weeks, and we believe the progress we have made over the past 12 months has positioned our team to successfully launch vadadustat in the U.S., if approved,\" said John P. Butler, Chief Executive Officer of Akebia. \"A U.S. approval for vadadustat will be transformational for Akebia and a significant step toward our goal of bettering the lives of people impacted by kidney disease. Our team remains dedicated to delivering an innovative oral therapeutic treatment for anemia due to chronic kidney disease for patients on dialysis.\"\nFourth Quarter 2023 and Recent Business Highlights: \nAppointed Nicholas Grund as Chief Commercial Officer, who brings years of expertise in customer-facing roles to Akebia. Mr. Grund's operational, commercial and strategic leadership experience across renal and specialty markets will be critical as Akebia prepares for the vadadustat launch in the U.S., if approved.Introduced new pipeline programs in acute care settings, potentially for acute kidney injury or acute respiratory distress syndrome (AKB-9090) and retinopathy of prematurity in neonates (AKB-10108).Closed a new debt facility with BlackRock that provides access to up to $55.0 million in borrowing capacity and used the proceeds from the first tranche of $37.0 million to pay down principal outstanding under the then loan agreement with Pharmakon Advisors, LP. The BlackRock debt facility, which closed on January 29, 2024, also extends the interest-only period in the event of vadadustat appr...