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Clinical trial readouts, FDA letters, and dialysis-channel contracts can turn Akebia Therapeutics’ stock overnight—yet the details are buried deep inside dense SEC exhibits. If you have ever searched for Akebia Therapeutics quarterly earnings report 10-Q filing or tried to untangle 300 pages of risk factors, you know the challenge.
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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.
Akebia Therapeutics reported Q3 2025 results showing higher revenue and a small profit. Total revenue was $58.8 million versus $37.4 million a year ago, driven by product revenue of $56.8 million. Net income was $0.5 million for the quarter; for the nine months, net income was $6.9 million versus a $46.6 million loss last year.
Cash and cash equivalents were $166.4 million as of September 30, 2025. Total assets were $364.2 million and stockholders’ equity improved to $41.6 million from a deficit at year-end 2024. The company launched Vafseo in the U.S. in January 2025, while Auryxia lost U.S. exclusivity in March 2025, with generic competition noted as an ongoing risk.
Akebia’s BlackRock term loan bears interest at SOFR (1‑month) plus 6.75% (all-in capped at 15.00%), with interest-only payments through December 31, 2026 and covenants requiring either a $15.0 million minimum cash balance in controlled accounts or $150.0 million of trailing twelve‑month revenue.
Akebia Therapeutics (AKBA) announced a strategic setback. After meeting with the U.S. Food and Drug Administration, the company did not reach alignment on the design of the VALOR clinical trial evaluating vadadustat for anemia in late-stage chronic kidney disease patients not on dialysis. As a result, Akebia does not plan to initiate VALOR and does not expect to pursue a broad U.S. label for Vafseo in non-dialysis dependent CKD.
This decision narrows the company’s near-term U.S. regulatory path for vadadustat in the non-dialysis setting and shifts focus away from a broad label expansion. The disclosure was made under Regulation FD and as an Other Event, highlighting its significance to the company’s clinical and commercial strategy.
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