# EDGAR Filing Document

**Accession Number:** 0001517022
**File Stem:** 0001193125-23-042806
**Filing Date:** 2023-2
**Character Count:** 12690
**Document Hash:** d9953d8d57ad983c9b5e618121b4655f
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-23-042806.hdr.sgml**: 20230221

**ACCESSION NUMBER**: 0001193125-23-042806

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230221

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230221

**DATE AS OF CHANGE**: 20230221

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Akebia Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001517022
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 208756903
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36352
- **FILM NUMBER:** 23645195

**BUSINESS ADDRESS:**
- **STREET 1:** 245 FIRST STREET
- **CITY:** CAMBRIDGE
- **STATE:** MA
- **ZIP:** 02142
- **BUSINESS PHONE:** 617-871-2098

**MAIL ADDRESS:**
- **STREET 1:** 245 FIRST STREET
- **CITY:** CAMBRIDGE
- **STATE:** MA
- **ZIP:** 02142

?xml version="1.0" encoding="utf-8" ? 8-K

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### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### Washington, D.C. 20549

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### FORM 8-K

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#### CURRENT REPORT

#### PURSUANT TO SECTION 13 OR 15(D)

#### OF THE SECURITIES EXCHANGE ACT OF 1934

#### Date of Report (Date of earliest event reported): February 21, 2023

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## AKEBIA THERAPEUTICS, INC.

#### (Exact name of registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| **Delaware** | **001-36352** | **20-8756903** |
| **(State or other jurisdiction**<br> **of incorporation)** | **(Commission**<br> **File Number)** | **(IRS Employer**<br> **Identification No.)** |

---

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| | |
|:---|:---|
| **245 First Street**<br> **Cambridge, Massachusetts** | **02142** |
| **(Address of principal executive offices)** | **(Zip Code)** |

---

#### Registrant's telephone number, including area code: (617) 871-2098

#### N/A

#### (Former name or former address, if changed since last report)

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | |
|:---|:---|
| **Title of each class** | **Name of each exchange**<br> **on which registered** |
| Common Stock, par value $0.00001 per share AKBA | The Nasdaq Capital Market |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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| | |
|:---|:---|
| **Item 8.01.** | **Other Events.**  |

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On February 21, 2023, Akebia Therapeutics, Inc. ("Akebia") issued a press release announcing that it received a second interim response from the U.S. Food and Drug Administration ("FDA") to its Formal Dispute Resolution Request ("FDRR") regarding the complete response letter for vadadustat received in March 2022. Akebia expects to be notified of a response to the appeal within 30 days of the FDA completing its internal discussions and any required follow up.

A copy of such press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

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| | |
|:---|:---|
| **Item 9.01.** | **Financial Statements and Exhibits.**  |

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(d) Exhibits

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| | |
|:---|:---|
| **Exhibit<br>No.** | **Description** |
| 99.1 | [Press Release, dated February 21, 2023, issued by Akebia Therapeutics, Inc.](d437984dex991.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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#### Forward-Looking Statement
Statements in this Current Report on Form 8-K regarding Akebia'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, and include, but are not limited to, statements regarding Akebia's expectations on the timing of a response from the FDA with respect to its appeal. The terms "expect," "intend," "believe," "plan," "goal," "potential," "will," "continue," derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: decisions made by health authorities, such as the FDA and the European Medicines Agency, with respect to regulatory filings, including the New Drug Application for vadadustat and the FDRR for vadadustat; the potential therapeutic benefits, safety profile, and effectiveness of vadadustat; the direct or indirect impact of the COVID-19 pandemic on regulators and Akebia's business, operations, and the markets and communities in which Akebia and its partners, collaborators, vendors and customers operate; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; early termination of any of Akebia's collaborations; and the competitive landscape for vadadustat, if approved. 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 September 30, 2022, 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 Current Report on Form 8-K, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this Current Report on Form 8-K.

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#### SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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| | | |
|:---|:---|:---|
|  |  | AKEBIA THERAPEUTICS, INC. |
| Date: February 21, 2023 | By: | /s/ John P. Butler |
|  | Name: | John P. Butler |
|  | Title: | President and Chief Executive Officer |

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## Exhibit 99.1

**Exhibit 99.1**![LOGO](g437984g0221023226002.jpg)

**Akebia Therapeutics Received Interim Response from the FDA to Appeal for Vadadustat** 

**for the Treatment of Anemia due to Chronic Kidney Disease** 

CAMBRIDGE, Mass.—February 21, 2023—<u>Akebia Therapeutics<sup>®</sup>, Inc</u>. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the company received a second interim response from the U.S. Food and Drug Administration to its Formal Dispute Resolution Request regarding the Complete Response Letter for vadadustat received in March 2022.

Akebia received notification from the Office of New Drugs (OND), Center for Drug Evaluation and Research, that due to agency resource constraints and staffing needs the deciding authority for the appeal will now be Peter Stein, M.D., Director, OND. The appeal was originally assigned to a Senior Advisor within the OND.

Dr. Stein has indicated a need to seek internal consultation with nephrology, cardiology and liver safety experts in the Office of New Drugs to complete the review and render a decision. Dr. Stein indicated that he will do all he can to facilitate the appropriate meetings and discussions given the delay resulting from the staffing change. Akebia expects to be notified of a response to the appeal within thirty days of Dr. Stein completing the discussions and any required follow up.

**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 <u>www.akebia.com</u>, which does not form a part of this release.

**About Vadadustat** 

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase 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. Vadadustat is an investigational new drug and is not approved by the U.S. Food and Drug Administration (FDA). On March 29, 2022, the FDA issued a complete response letter to Akebia's New Drug Application for vadadustat for the treatment of anemia due to chronic kidney disease (CKD). In November 2022, Akebia submitted a Formal Dispute Resolution Request focused on the favorable balance of the benefits and risks of vadadustat for the treatment of anemia due to CKD in adult patients on dialysis. Vadadustat is currently under review by the European Medicines Agency for the treatment of anemia due to CKD in adults. In Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.

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**Forward Looking Statement** 

Statements in this press release regarding Akebia Therapeutics, Inc.'s ("Akebia'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, and include, but are not limited to, statements regarding: Akebia's expectations on the timing of a response from the FDA with respect to its appeal. The terms "expect," "intend," "believe," "plan," "goal," "potential," "will," "continue," derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: decisions made by health authorities, such as the FDA and the European Medicines Agency, with respect to regulatory filings, including the New Drug Application for vadadustat and the Formal Dispute Resolution Request for vadadustat; the potential therapeutic benefits, safety profile, and effectiveness of vadadustat; the direct or indirect impact of the COVID-19 pandemic on regulators and Akebia's business, operations, and the markets and communities in which Akebia and its partners, collaborators, vendors and customers operate; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; early termination of any of Akebia's collaborations; and the competitive landscape for vadadustat, if approved. 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 September 30, 2022, 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<sup>®</sup> is a registered trademark of Akebia Therapeutics, Inc.

**Akebia Therapeutics Contact** 

Mercedes Carrasco

mcarrasco@akebia.com