Stock To Watch: Will 2020 Be A Defining Year For Akebia (AKBA)?

Shares of Akebia Therapeutics Inc. (AKBA), which touched a new 52-week high of $10.42 in intraday trading yesterday, have gained an impressive 65 percent so far this year.

Akebia is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease. The Company currently markets Auryxia (ferric citrate) in the U.S. for its two approved indications - i.e., for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis, and for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis.

Auryxia is also approved and marketed in Japan under the trade name Riona. The Company's Japanese sublicensee, JT, and its subsidiary, Torii, markets Riona in Japan. Although the drug is approved, it is not currently marketed in the EU.

Auryxia came under Akebia's fold following the acquisition of Keryx Biopharmaceuticals in 2018. There has been a significant growth in the sales of Auryxia, driven by demand in both the hyperphosphatemia and iron deficiency anemia markets.

Sales of Auryxia, which totaled $55.5 million in 2017, grew to $96 million in 2018. In the nine months ended September 30, 2019, Auryxia sales were $82.2 million.

Akebia has one investigational product in its pipeline by the name Vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor.

-- A global phase III study evaluating Vadadustat in dialysis-dependent chronic kidney disease (CKD) subjects with anemia due to CKD, dubbed INNO2VATE, is ongoing, with top-line data expected in the second quarter of 2020.

-- A phase III program evaluating Vadadustat in non-dialysis dependent CKD subjects with anemia due to CKD, dubbed PRO2TECT, is also underway, with top-line results expected in mid-2020.

In July 2019, Akebia's development and commercialization collaboration partner in Japan for Vadadustat, Mitsubishi Tanabe Pharma Corporation (MTPC), submitted a Japanese New Drug Application (JNDA) to the Ministry of Health, Labor and Welfare in Japan for marketing approval of Vadadustat as a treatment for anemia due to CKD. The approval of Vadadustat in Japan is anticipated this year.

Akebia is partnered with Vifor and Otsuka Pharma for the commercialization of Vadadustat in the U.S. Otsuka also has exclusive rights to commercialize Vadadustat in Europe, China and certain other markets, subject to marketing approvals.

The Company ended September 30, 2019, with cash, cash equivalents and available-for-sale securities of $145.6 million.

Akebia is slated to report financial results for its fourth quarter and full-year ended December 31, 2019, next month.

AKBA has traded in a range of $2.99 to $10.42 in the last 1 year.

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