Press Release

Akebia Therapeutics to Report Third Quarter 2021 Financial Results and Highlight Recent Company Milestones

October 26, 2021 at 8:00 AM EDT
Company to Host Conference Call to Discuss Vadadustat Phase 3 Clinical Data and Pre-Commercial Readiness

CAMBRIDGE, Mass., Oct. 26, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (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 third quarter ended September 30, 2021, on Thursday, November 4, 2021 before the opening of the financial markets.

Akebia will host a conference call Tuesday, November 9 at 9:00 a.m. ET to discuss its third quarter financial results and recent business highlights. Executives will highlight publications and scientific presentations of vadadustat global Phase 3 clinical data, which will be presented at the American Society of Nephrology Kidney Week 2021 beginning November 4, 2021. The Company will also discuss pre-commercialization readiness activities that are underway in anticipation of its 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.

To listen to the conference call on November 9th, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 5389484. The call will also be webcast LIVE and can be accessed via the Investors section of the Company's website at

A replay of the conference call will be available two hours after the completion of the call through November 15, 2021. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 5389484. An online archive of the conference call can be accessed via the Investors section of the Company's website at

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. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at, which does not form a part of this release.

About Vadadustat
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
Statements in this press release regarding Akebia's or Otsuka's strategy, plans, prospects, expectations, beliefs, intentions and goals are 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 launch of vadadustat, if approved, and the timing thereof. The terms "expect," "will," "confident," "expect," "plan," "continue," "potential," and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including, but not limited to: the timing of certain regulatory approvals; interactions with FDA, including reviews and inspections, the timing related thereto and the outcome thereof; the potential therapeutic benefits, safety profile and effectiveness of vadadustat, including the risk that vadadustat may cause undesirable side effects or have other properties that delay or limit its commercial potential or prevent its marketing approval; the timing and content of advice given and decisions made by health authorities, including approval and labeling decisions. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Quarterly Report on Form 10-Q for the quarter ended June 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. 

Akebia Therapeutics® is a registered trademark of Akebia Therapeutics, Inc. 

Akebia Therapeutics IR Contact
David A. Spellman 

Akebia Therapeutics Media Contact
Mercedes Carrasco 

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