EMA panel endorses Akebia’s kidney disease treatment

CAMBRIDGE, Mass. - Akebia Therapeutics, Inc. (NASDAQ: AKBA), a biopharmaceutical firm focused on kidney disease treatments with a market capitalization of $456 million and impressive gross margins of 84%, announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended XOANACYL® for approval. According to InvestingPro analysis, while the company currently appears overvalued, it maintains a FAIR overall financial health score. This medication is designed to treat adults with chronic kidney disease (CKD) who have both elevated serum phosphorous and iron deficiency.

The positive opinion from CHMP is a crucial step towards full European Commission (EC) authorization, with a final decision expected in approximately two months. XOANACYL®, known scientifically as Ferric Citrate as Coordination Complex, could soon provide a new therapeutic option for CKD patients in Europe if approved.

Averoa, a renal-focused biopharmaceutical company, has obtained the rights to develop and commercialize ferric citrate in the European Economic Area, along with select countries in Europe and the Middle East. The partnership with Akebia allows Averoa to leverage Akebia’s research and development in the renal disease sector.

John P. Butler, CEO of Akebia, expressed his company’s commitment to supporting Averoa’s efforts to navigate the regulatory landscape and bring XOANACYL® to the European market. Akebia’s mission is to improve the lives of those affected by kidney disease, and this development represents a significant stride in that direction.

The announcement is based on a press release statement from Akebia Therapeutics, which has been operational since 2007 with headquarters in Cambridge, Massachusetts. The company’s stock has shown strong momentum, gaining over 46% in the past six months, according to InvestingPro data. While the company has expressed optimism regarding the eventual EC approval of XOANACYL®, it’s important to note that forward-looking statements are subject to various risks and uncertainties. These include regulatory decisions, clinical research outcomes, and manufacturing challenges that could impact the availability and success of the treatment.

Investors and stakeholders in the biopharmaceutical sector will be watching closely for the EC’s final decision, which could influence Akebia’s market position and the landscape of CKD treatment options in Europe. With annual revenue of $160 million and analyst price targets suggesting significant upside potential, detailed analysis and comprehensive insights are available in the Pro Research Report on InvestingPro, part of their coverage of over 1,400 US equities.

In other recent news, Akebia Therapeutics has reported several significant developments that may interest investors. The company has initiated a public stock offering, with Leerink Partners and Piper Sandler & Co. serving as joint bookrunning managers. This follows a shelf registration statement filed with the SEC, although the completion of the offering is subject to market conditions. In terms of financial performance, Akebia’s product Vafseo has shown promising results, with first-quarter 2025 revenue projections between $10 million and $11 million, surpassing previous estimates.

Jefferies has initiated coverage on Akebia Therapeutics with a Buy rating and a price target of $6.00, citing the potential for Vafseo to achieve durable sales. Similarly, Piper Sandler has maintained an Overweight rating with a $6.00 price target, reflecting confidence in Vafseo’s performance and future market opportunities. H.C. Wainwright also reiterated a Buy rating, but with a higher price target of $7.50, highlighting Vafseo’s strong early commercial performance and the company’s strategic approach.

The company’s strategy, known as the "coiled spring" strategy, aims to secure contracts with dialysis organizations and build prescriber demand. This has led to more than 500 prescribing physicians and over 4,000 prescriptions for Vafseo, significantly outpacing a competing drug, Xphozah. Despite these positive indicators, Akebia faces challenges such as the anticipated decline in sales of Auryxia due to loss of exclusivity in 2025. Nevertheless, analysts from firms like Piper Sandler and H.C. Wainwright express optimism about Akebia’s trajectory and the potential success of Vafseo in the market.

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