UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_____________________

FORM 8-K

_____________________

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(D)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): November 1228, 2025

_____________________

AKEBIA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

_____________________

Delaware

001-36352

20-8756903

(State or other jurisdiction
of incorporation)

(Commission
File Number)

(IRS Employer
Identification No.)



245 First Street 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)

_____________________

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:

Title of each class

Trading
symbol(s)

Name of each exchange
on which registered

Common Stock, par value $0.00001 per share

AKBA

The Nasdaq Capital Market

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. ☐

Item 1.01. Entry into a Material Definitive Agreement.

AsOn ~~previously~~November ~~disclosed~~28, on2025 ~~May~~(the ~~24,~~“Closing ~~2023~~Date”), Akebia Therapeutics, Inc. (the “Company”) ~~and~~entered ~~MEDICE~~into ~~Arzneimittel~~an ~~Putter~~Asset ~~GmbH~~Purchase &Agreement ~~Co. KG~~ (the “~~Medice~~Agreement”) ~~entered~~with ~~into~~Q32 aBio ~~License~~Inc. ~~Agreement~~and Q32 Bio Operations Inc. (~~the~~together, “~~License Agreement~~Q32”), pursuant to which Q32 sold and assigned to the Company, ~~granted~~and tothe ~~Medice~~Company anpurchased ~~exclusive~~and ~~license~~assumed from Q32, substantially all assets and liabilities of Q32 and its affiliates related to ~~develop~~the research, development, manufacture, and ~~commercialize~~commercialization ~~Vafseo~~of Q32’s clinical-stage development candidate known as ADX-097 worldwide for the treatment, prevention or diagnosis of ~~anemia~~any disease or condition in ~~patients~~humans. ~~with~~ADX-097, ~~chronic~~which ~~kidney~~has ~~disease~~been evaluated in ~~Europe~~a ~~and~~Phase ~~certain~~1 ~~other~~clinical ~~countries~~trial in healthy volunteers, is a tissue-targeted C3d-Factor H fusion protein complement inhibitor with the potential to treat rare kidney diseases.

OnUnder ~~November~~the ~~12,~~terms ~~2025~~of the Agreement, the Company ~~and~~(i) ~~Medice~~made ~~entered~~an ~~into~~upfront ~~Amendment~~payment #1in an amount equal to ~~License~~$7.0 ~~Agreement~~million (on the ~~“Amendment”~~Closing Date, (ii). ~~Pursuant~~will make an additional upfront payment in an amount equal to $3.0 million on the ~~Amendment~~sixth-month anniversary of the Closing Date, (iii) will make certain milestone payments upon the ~~Company~~achievement ~~agreed~~of tospecified ~~supply~~development ~~vadadustat~~and ~~drug~~regulatory ~~substance~~milestone ~~(“Drug~~events ~~Substance”)~~related to ~~Medice~~the ~~pursuant~~ADX-097 up to an aggregate amount equal to $94.5 million, including a $2.0 million development milestone payment upon the ~~terms~~earlier of initiation of a ~~supply~~Phase ~~agreement~~2 ~~dated~~clinical ~~concurrently~~trial and December 31, 2026, (iv) will make certain milestone payments upon the achievement of specified commercial milestone events with respect to the ~~Amendment~~net sales of ADX-097 up to an aggregate amount equal to $487.5 million, and ~~granted~~(v) ~~Medice~~will make certain royalty payments based on the ~~right~~net tosales ~~manufacture~~of ~~Vafseo~~ADX-097 ~~tablets~~with ~~using~~royalty percentage tiers ranging from the ~~Drug~~low ~~Substance~~single digits to bemid-teen ~~supplied~~percentages. The royalties will expire on a country-by-country basis on the ~~Company.~~later Into ~~addition,~~occur of (a) the ~~Amendment~~date ~~provides~~of ~~that~~expiration ~~any~~of ~~know~~the last-~~how~~to-expire orvalid claim of any transferred patent ~~rights~~right ~~arising~~that ~~out~~covers ofsuch ~~Medice’s~~product ~~manufacture~~in ofsuch ~~Vafseo~~country, ~~tablets~~and ~~will~~(b) bethe ~~owned~~tenth byanniversary of the ~~Company~~first commercial sale of such product.

The ~~foregoing~~Agreement ~~description~~includes ofcustomary ~~the~~representations, ~~Amendment~~warranties, ~~does~~conditions, ~~not~~covenants, ~~purport~~and toindemnification berights ~~complete~~ and isobligations ~~qualified in its entirety by reference to the Amendment, a copy~~ of ~~which~~ the Company ~~expects~~and ~~to file as an exhibit to its Annual Report on Form 10-K for the year ended December 31, 2025~~Q32.

The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the Agreement, a copy of which the Company expects to file as an exhibit to its Annual Report on Form 10-K for the year ended December 31, 2025.

Item 7.01. Regulation FD Disclosure.

On December 1, 2025, the Company issued a press release announcing the acquisition of a clinical-stage development candidate and the establishment of its rare kidney disease pipeline comprised of two core product candidates: ADX-097 (now referred to as AKB-097), a complement inhibitor, and praliciguat, a soluble guanylate cyclase stimulator. A copy of the Company’s press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

In addition, pursuant to the terms of Amendment #1 to the License Agreement, dated June 3, 2021, by and between the Company and Cyclerion Therapeutics, Inc., a Massachusetts corporation (“Cyclerion”), upon initiation (defined as first patient dosed) of a Phase 2 clinical trial in the U.S. for a product, a $1.0 million regulatory milestone payment will be due to Cyclerion.

The information in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.

Item 8.01. Other Events.

The Company currently expects that its existing cash resources and cash from operations will be sufficient to fund its current operating plan for at least 2 years. There can be no assurance that the current operating plan will be achieved in the time frame anticipated by the Company, or that the Company’s cash resources will fund its operating plan for the period of time anticipated by it, or that additional funding will be available on terms acceptable to the Company, or at all. The Company’s forecast of the period of time through which its financial resources will be adequate to support its operations is a forward-looking statement and involves numerous risks and uncertainties, and actual results could vary as a result of a number of factors, many of which are outside its control. The Company has based this estimate on assumptions that may be substantially different than actual results, and the Company could utilize its available capital resources sooner than it currently expects. The Company does not plan to comment on profitability expectations at this time.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits



Exhibit No.						Description
99.1						Press Release, dated December 1 , 202 5 , issued by Akebia Therapeutics, Inc.
104						Cover Page Interactive Data File (embedded within the Inline XBRL document)

Cautionary Note Regarding Forward-Looking Statements

This Current Report on Form 8-K (the “Report”) contains forward-looking statements of the Company that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Report are forward-looking statements. The words “anticipate,” “believe,” “build,” “can,” “contemplate,” “continue,” “could,” “should,” “designed,” “estimate,” “project,” “expect,” “forecast,” “future,” “goal,” “intend,” “likely,” “may,” “plan,” “possible,” “potential,” “predict,” “strategy,” “seek,” “target,” “will,” “would,” derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements relating to the Company’s expectations that its existing cash resources and cash from operations will be sufficient to fund its current operating plan for at least two years. Actual results may differ materially from those projected or implied in these forward-looking statements. You should not place undue reliance on these forward-looking statements. Certain risks and uncertainties relating to the Company and its business can be found under the caption “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, and other filings that the Company may make with the U.S. Securities and Exchange Commission in the future. Any forward-looking statements contained in this Report (except as otherwise noted) speak only as of the date hereof, and, except as required by law, the Company does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this Report.

SIGNATURE

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.

		AKEBIA THERAPEUTICS, INC.
Date: November 17, 2025	By:	/s/ John P. Butler
Date: December 1, 2025	By:	/s/ John P. Butler
		Name: John P. Butler
		Title: President and Chief Executive Officer

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