On Monday, H.C. Wainwright adjusted its price target on Akebia Therapeutics (NASDAQ:AKBA), increasing it to $6.00 from the previous $5.00, while reiterating a Buy rating on the stock. This change follows the recent FDA approval of Akebia's Vafseo for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. The approval, announced on March 27, was anticipated by the market and applies to patients who have been on dialysis for a minimum of three months.
During a conference call this morning, Akebia's management highlighted that the approved patient segment represents about 375,000 individuals within the total U.S. addressable market of 500,000 adult dialysis patients suffering from anemia due to CKD.
The firm considers the three-month dialysis requirement before treatment with Vafseo a minor limitation, noting its temporary nature. The FDA regards this as a class labeling issue, which is also reflected in a similar drug by GSK (LON:GSK), Jesduvroq, which is limited to patients on dialysis for at least four months.
Despite the restriction, Akebia does not see it as necessary for Vafseo and plans to negotiate with the FDA to remove this limitation in the future. The analyst views the FDA's approval and the drug's label as favorable compared to the competitor, despite the expected black box warnings for all drugs in this class. The slight delay in Vafseo's launch is seen as a strategic move by Akebia.
The analyst commended Akebia's management for their determination in overcoming the previous Complete Response Letter (CRL) and securing the FDA's approval for Vafseo. The approval marks a significant milestone for the company, which is now reflected in the raised price target for Akebia's shares.
InvestingPro Insights
Following the positive outlook from H.C. Wainwright on Akebia Therapeutics, current InvestingPro data provides a deeper look into the company's financial health and market performance. Akebia's market capitalization stands at $354.47 million, which is a critical metric for investors gauging the company's size and market value. Despite the challenges, Akebia has demonstrated a strong return over the last three months, with a price total return of 47.58%, and an even more impressive one-year price total return of 226.55%.
InvestingPro Tips suggest that while Akebia has a high shareholder yield, the stock has taken a significant hit over the last week, declining by 17.19%. This could be a point of concern for short-term investors, but the company's recent FDA approval may provide a counterbalance. Furthermore, analysts do not anticipate the company will be profitable this year, and Akebia does not pay dividends, which might be important for income-focused investors to consider.
For those interested in a more comprehensive analysis, InvestingPro offers additional insights, including 7 more InvestingPro Tips for Akebia Therapeutics, which can be accessed through the platform. Remember to use coupon code PRONEWS24 to receive an additional 10% off a yearly or biyearly Pro and Pro+ subscription, offering a richer perspective on investment decisions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.