Welcome to our dedicated page for Akebia Therapeut SEC filings (Ticker: AKBA), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Akebia Therapeutics, Inc. (Nasdaq: AKBA) SEC filings page on Stock Titan aggregates the company’s regulatory disclosures from the U.S. Securities and Exchange Commission, offering investors structured access to its official communications. As a biopharmaceutical company focused on kidney disease, Akebia uses filings such as Forms 8-K, 10-K, and 10-Q to report material agreements, financial performance, and key clinical and regulatory developments related to products like Vafseo (vadadustat) and Auryxia (ferric citrate), as well as its rare kidney disease pipeline.
Recent 8-K filings illustrate the type of information investors can expect. One filing describes an amendment to Akebia’s License Agreement with MEDICE Arzneimittel Putter GmbH & Co. KG, under which Akebia supplies vadadustat drug substance and Medice has rights to manufacture Vafseo tablets for Europe and certain other countries, with resulting know-how and patent rights owned by Akebia. Other 8-Ks furnish quarterly financial results, highlight business updates such as Vafseo commercialization metrics, and disclose regulatory decisions, including Akebia’s announcement that it does not plan to initiate the VALOR trial and does not expect to pursue a broad label for Vafseo in CKD patients not on dialysis.
Through this page, users can review annual reports on Form 10-K for comprehensive discussions of risk factors, product portfolios, and strategy; quarterly reports on Form 10-Q for interim financial and operational updates; and current reports on Form 8-K for material events. Insider transaction reports on Form 4, when available, provide visibility into equity transactions by directors and officers. Stock Titan enhances these filings with AI-powered summaries that explain key points, highlight material changes, and help readers quickly understand how new disclosures may relate to Akebia’s kidney disease programs and overall business.
Akebia Therapeutics, Inc. furnished an update focused on its Vafseo® (vadadustat) commercial business and future growth plans. The company issued a press release outlining key corporate updates, an outlook on upcoming milestones, and highlighted its next anticipated growth driver in its mid-stage rare kidney disease pipeline. It also shared an overview of expected fourth quarter 2025 Vafseo net product revenue.
Akebia is also making a corporate presentation available, which its spokespersons plan to use at investor and analyst meetings, including sessions coinciding with the 44th Annual J.P. Morgan Healthcare Conference. Both the press release and the presentation are attached as exhibits and are being furnished, not filed, under the securities laws.
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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