Akebia Therapeutics Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement
$AKBA
Biotechnology: Pharmaceutical Preparations
Health Care
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): November 12, 2025
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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 | ||||||||