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On Thursday, H.C. Wainwright maintained its Buy rating and $7.50 price target for Akebia Therapeutics (NASDAQ:AKBA). The firm’s analyst highlighted the recent development where the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Akebia’s drug XOANACYL for treating adult patients with chronic kidney disease (CKD) who have both elevated serum phosphorus and iron deficiency.
The CHMP’s favorable opinion, announced on Wednesday, is a significant step toward the European Commission’s (EC) final decision, which is anticipated by June 2025. While the EC is not bound to adhere to the CHMP’s advice, it is noted that such a positive recommendation often results in EC approval. XOANACYL, known as Auryxia in the U.S., has a strong backing with data from three pivotal trials, increasing the confidence in its potential EC approval. This development has contributed to the stock’s impressive 41% surge over the past six months, as tracked by InvestingPro.
The analyst emphasized the importance of this milestone for Akebia, as XOANACYL’s marketing and commercialization efforts in Europe are led by Averoa, a private biopharmaceutical company based in Meylan, France. Averoa specializes in renal therapies, which aligns with Akebia’s strategic focus.
Akebia’s attention continues to be on the U.S. market, particularly on gaining commercial traction for Vafseo (vadadustat), which treats anemia due to CKD in adult patients on dialysis. Additionally, the company is preparing for the VALOR Phase 3 cardiovascular outcome study (CVOT) in U.S. non-dialysis dependent CKD patients, which is set to commence in the second half of 2025.
H.C. Wainwright’s reaffirmation of the Buy rating and the $7.50 price target reflects the firm’s confidence in Akebia’s strategic initiatives and the anticipated regulatory approvals that could enhance the company’s market position. For deeper insights into Akebia’s financial health, valuation metrics, and comprehensive analysis, investors can access the detailed Pro Research Report available on InvestingPro, which provides expert analysis on this and 1,400+ other US stocks.
In other recent news, Akebia Therapeutics has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use for its kidney disease treatment, XOANACYL®. This recommendation is a significant step toward European Commission authorization, expected in about two months. Meanwhile, Jefferies initiated coverage of Akebia with a Buy rating and a price target of $6.00, highlighting the potential for the company’s lead product, Vafseo, to achieve durable sales. Piper Sandler also maintained an Overweight rating with the same price target, noting Vafseo’s strong initial performance, which exceeded expectations in the dialysis market. Additionally, H.C. Wainwright reiterated a Buy rating with a higher price target of $7.50, citing Vafseo’s accelerating prescription rates and surpassing net sales guidance for the first quarter of 2025. Akebia Therapeutics recently launched a public stock offering, with Leerink Partners and Piper Sandler serving as joint bookrunning managers. This offering follows a shelf registration with the SEC, although its completion is subject to market conditions. Investors are closely monitoring these developments as Akebia continues to expand its market reach and product lineup.
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