[8-K] Akebia Therapeutics, Inc. Reports Material Event

Rhea-AI Filing Summary

Akebia Therapeutics, Inc. entered into an amendment to its existing license agreement with Medice Arzneimittel Putter GmbH & Co. KG related to Vafseo, its treatment for anemia in chronic kidney disease. The amendment, dated November 12, 2025, adds a new supply and manufacturing structure.

Under the amendment, Akebia will supply vadadustat drug substance to Medice under a separate supply agreement, and Medice is granted the right to manufacture Vafseo tablets using that material. Any new know-how or patent rights that arise from Medice’s manufacturing activities will be owned by Akebia, helping Akebia retain control over future intellectual property linked to Vafseo tablet production in the licensed territories.

Insights

Biopharmaceutical partnerships analyst

Akebia tightens IP control while expanding Vafseo manufacturing roles with Medice.

Akebia Therapeutics has amended its license agreement with Medice for Vafseo, shifting to a model where Akebia supplies vadadustat drug substance and Medice manufactures finished Vafseo tablets. This formalizes the supply chain for the licensed European and other territories and clarifies each party’s role in converting active ingredient into commercial product.

A key feature is that any know-how or patent rights arising from Medice’s Vafseo tablet manufacturing will be owned by Akebia. This structure can concentrate future intellectual property around Vafseo with Akebia, even when process innovations occur at Medice’s facilities, potentially strengthening Akebia’s long-term control over the asset.

The practical impact will depend on how quickly Medice scales tablet manufacturing and any process improvements that emerge. Details such as commercial terms, volumes, or pricing are not provided in this excerpt, so financial effects are not quantifiable here, but the amendment underscores the ongoing build-out of the Vafseo commercialization framework in Medice’s territories.

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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 12, 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.

As previously disclosed, on May 24, 2023, Akebia Therapeutics, Inc. (the “Company”) and MEDICE Arzneimittel Putter GmbH & Co. KG (“Medice”) entered into a License Agreement (the “License Agreement”) pursuant to which the Company granted to Medice an exclusive license to develop and commercialize Vafseo for the treatment of anemia in patients with chronic kidney disease in Europe and certain other countries.

On November 12, 2025, the Company and Medice entered into Amendment #1 to License Agreement (the “Amendment”). Pursuant to the Amendment, the Company agreed to supply vadadustat drug substance (“Drug Substance”) to Medice pursuant to the terms of a supply agreement dated concurrently with the Amendment and granted Medice the right to manufacture Vafseo tablets using the Drug Substance to be supplied by the Company. In addition, the Amendment provides that any know-how or patent rights arising out of Medice’s manufacture of Vafseo tablets will be owned by the Company.

The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the Amendment, 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.

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
						Name: John P. Butler
						Title: President and Chief Executive Officer

FAQ

What did Akebia Therapeutics (AKBA) announce in this 8-K?

Akebia Therapeutics reported that it entered into Amendment #1 to its existing license agreement with Medice, covering the drug Vafseo for anemia in chronic kidney disease, to add new supply and manufacturing terms.

How does the amended agreement with Medice change Akebia’s Vafseo arrangement?

The amendment provides that Akebia will supply vadadustat drug substance to Medice and grants Medice the right to manufacture Vafseo tablets using that supplied material.

Who owns new intellectual property from Vafseo tablet manufacturing under the amendment?

Any know-how or patent rights that arise from Medice’s manufacture of Vafseo tablets will be owned by Akebia, consolidating future manufacturing-related IP with the company.

Does the Akebia–Medice amendment disclose financial terms or revenue figures?

The excerpt describes the supply, manufacturing, and intellectual property arrangements but does not state specific financial terms, pricing, or revenue figures related to the amendment.

When was Amendment #1 to the Akebia–Medice license agreement signed?

The amendment to the license agreement between Akebia and Medice was entered into on November 12, 2025.

Where will investors be able to see the full text of the amendment?

Akebia expects to file a copy of Amendment #1 as an exhibit to its Annual Report on Form 10-K for the year ended December 31, 2025.