CAMBRIDGE, Mass., Feb. 9, 2022 /PRNewswire/ --Akebia Therapeutics (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced plans to release its financial results for the fourth quarter and full-year 2021 ended December 31, 2021, on Tuesday, March 1, 2022.
Akebia will not host a conference call due to the proximity to the anticipated March 29, 2022 Prescription Drug User Fee Act (PDUFA) target action date for vadadustat, which is under review by the U.S. Food and Drug Administration as a treatment for anemia due to chronic kidney disease.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.
Vadadustat is a potential first-in-class oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. The New Drug Application (NDA) for vadadustat for the treatment of anemia due to chronic kidney disease (CKD) is under review by the U.S. Food and Drug Administration (FDA). Vadadustat is an investigational new drug and is not approved by the FDA or any regulatory authority with the exception of Japan's Ministry of Health, Labour and Welfare (MHLW). In Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.
Forward Looking Statement
This press release includes forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements regarding: vadadustat's potential to be a first-in-class HIF-PH inhibitor for the treatment of anemia due to chronic kidney disease in the U.S. and the anticipated scheduled PDUFA date for vadadustat. The terms "plan," 'will," "anticipate," "potential," and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are not historical facts, but instead represent only Akebia's beliefs regarding future events, many of which, by their nature, are inherently uncertain and outside of Akebia's control. For a discussion of the risks related to the forward-looking statements in this press release see the "Risk Factors" section in Akebia's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.
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SOURCE Akebia Therapeutics