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CAMBRIDGE, Mass. - Akebia Therapeutics, Inc. (NASDAQ: NASDAQ:AKBA), a biopharmaceutical company focused on kidney disease treatments, has announced the commencement of shipments for their anemia treatment, Vafseo® (vadadustat), in the U.S. for adult patients with chronic kidney disease (CKD) on dialysis. The company, currently valued at approximately $382 million, has shown strong momentum with a nearly 39% price return over the past six months, according to InvestingPro data. The company has secured commercial supply contracts with dialysis organizations that cover nearly all dialysis patients in the U.S., including recent agreements with major and mid-size providers.
Akebia also revealed plans to initiate a Phase 3 trial in mid-2025 to explore the potential use of vadadustat for anemia in late-stage CKD patients not on dialysis. This follows the U.S. Food and Drug Administration's (FDA) feedback on Akebia's protocol submission for a label expansion study. The company has received guidance from the FDA and is integrating it into their trial preparations.
Vafseo qualifies for the Transitional Drug Add-On Payment Adjustment (TDAPA) reimbursement by the Centers for Medicare & Medicaid Services (CMS), which has published billing and reimbursement rates. Market research by Akebia suggests a high willingness among nephrologists to prescribe Vafseo, with indications that 75% intend to do so within six months of product availability.
In December 2024, U.S. Renal Care began enrolling patients in the VOICE collaborative clinical trial of Vafseo, now having enrolled over 650 patients. The FDA approved Vafseo for treating anemia due to CKD in adults on dialysis for at least three months in March 2024. However, it is not indicated for immediate correction of anemia or for patients with anemia due to CKD not on dialysis.
John P. Butler, CEO of Akebia, expressed optimism about the company's position and the potential of Vafseo to become a new standard of care for CKD patients. The company anticipates that its existing cash resources and cash from operations will sustain its current operating plan, including the U.S. Vafseo launch and planned pipeline advancement, for at least two years. InvestingPro data shows the company maintains a healthy current ratio of 1.52 and an impressive gross profit margin of 84%, while receiving a "GOOD" overall financial health score.
Akebia will discuss these business updates at the 43rd Annual J.P. Morgan Healthcare Conference on Thursday, January 16th, 2025.
This article is based on a press release statement from Akebia Therapeutics, Inc.
In other recent news, Akebia Therapeutics reported its third-quarter financial results, highlighting a decrease in total revenue to $37.4 million from $42 million in the same quarter of the previous year. Despite this, Akebia is actively preparing for the January 2025 launch of its anemia drug, Vafseo. The company reported a net loss of $20 million for the quarter, primarily due to increased spending on Vafseo's prelaunch activities and a decline in revenue from its existing product, AURYXIA.
Akebia has secured reimbursement agreements and is actively engaging with the medical community to support Vafseo's benefits. The company is optimistic about Vafseo's potential, particularly in the dialysis and non-dialysis chronic kidney disease patient segments.
In other company developments, Akebia is planning to start enrollment for the VOICE trial for Vafseo soon. The company is also focused on expanding dialysis center supply contracts from 60% to 100% by the Vafseo launch date.
These are recent developments that aim to maintain revenue levels despite impending generic competition for AURYXIA and to secure the company's position in the market.
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