Legal & controls
Item 3 and Item 9A as filed · every verdict is the registrant’s own sentence, printed below it · a filing that fails an extraction gate reads “not extracted”
| Fiscal year | Filed | Item 3 | ICFR | disclosure controls | material weakness | Filing |
|---|---|---|---|---|---|---|
| 2025-12-31 | 2026-02-26 | described here | effective | effective | remediated (prior year) | EDGAR |
Item 3 · From time to time, we may be involved in legal proceedings arising from the normal course of business activities. Opposition Proceedings Against Akebia In September 2018, Dr. Reddy’s Laboratories Limited filed an opposition to our issued Indian Patent No. 287720 covering the composition of matter of vadadustat in the Indian Patent Office. In response to a preliminary opinion, we requested to amend the claims, and the amended claims were published on May 9, 2025. On December 19, 2025, we attended an oral hearing conducted on the basis of the amended claims. On November 6, 2024, Sandoz AG, or Sandoz, filed an opposition against our issued European Patent No. 3007695 covering vadadustat once daily dosing regimen in the European Patent Office, or the EPO. On March 18, 2025, we timely submitted a Patent Proprietor’s Reply to the Notice of Opposition. Oral proceedings were scheduled for February 24-25, 2026. However, on December 8, 2025, Sandoz withdrew the opposition and the EPO issued a Brief Communication on December 11, 2025, stating that Sandoz is no longer a party to the proceedings. On January 13, 2026, the EPO issued a Brief Communication stating that the oral proceedings are can… Item 9A · ICFR · Based on this assessment, our management has concluded that our internal control over financial reporting was effective as of December 31, 2025. Item 9A · disclosure controls · Based upon their evaluation, our principal executive officer and principal financial officer concluded that as of December 31, 2025, our disclosure controls and procedures were effective at a reasonable assurance level. Item 9A · material weakness · Remediation of Previously Identified Material Weakness As disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024, management identified a material weakness in our internal control over financial reporting relating to our inventory process. | ||||||
| 2024-12-31 | 2025-03-13 | described here | NOT effective | NOT effective | disclosed | EDGAR |
Item 3 · From time to time, we may be involved in legal proceedings arising from the normal course of business activities. Opposition Proceedings Against Akebia In September 2018, Dr. Reddy’s Laboratories Limited filed an opposition to our issued Indian Patent No. 287720 covering the composition of matter of vadadustat in the Indian Patent Office. On November 6, 2024, Sandoz AG filed an opposition against our issued European Patent No. 3007695 covering vadadustat once daily dosing regimen in the European Patent Office. Item 9A · ICFR · As a result of this assessment, our management has concluded that the material weakness in our internal control over financial reporting relating to our inventory process as reported in our Annual Report on Form 10-K for the year ended December 31, 2023 was not fully remediated as of December 31, 2024 and that our internal control over financial reporting as of December 31, 2024 was not effective as described below. Item 9A · disclosure controls · Based upon their evaluation, our principal executive officer and principal financial officer concluded that as of December 31, 2024, our disclosure controls and procedures were not effective because of a material weakness in the design of our internal control over financial reporting related to our accounting for inventories and inventory related transactions which is described in more detail below. | ||||||
| 2023-12-31 | 2024-03-14 | described here | NOT effective | NOT effective | disclosed | EDGAR |
Item 3 · Opposition Proceedings Against Akebia In September 2018, Dr. Reddy’s Laboratories Limited filed an opposition to our issued Indian Patent No. 287720 in the Indian Patent Office. Akebia Therapeutics, Inc. | Form 10-K | Page 106 On July 26, 2022, Sandoz AG filed an opposition against our issued European Patent No. 3277270 in the European Patent Office, or the EPO. During an oral proceeding held on February 6, 2024, the EPO's Opposition Division rejected the opposition and upheld the patent as granted. Settled Opposition Proceedings Against Akebia On February 13, 2023, FibroGen, Inc., or FibroGen, filed an opposition against our issued European Patent No. 3357911, or the ’911 EP Patent, in the EPO. On November 21, 2023, we and our collaboration partner in Japan, Mitsubishi Tanabe Pharma Corporation, or MTPC, entered into a Settlement and Cross License Agreement, or the Settlement Agreement, with FibroGen and its collaboration partner in Europe and Japan, Astellas Pharma Inc., or Astellas. This Settlement Agreement resolves all patent disputes between Akebia, MTPC, FibroGen and Astellas in the EU, the contracting states to the European Patent Convention, the UK, and Japan with no cash… Item 9A · ICFR · As a result of this assessment, our management has concluded that, as of December 31, 2023, our internal control over financial reporting was ineffective due to the material weakness described below. Item 9A · disclosure controls · Based upon their evaluation, our principal executive officer and principal financial officer concluded that as of December 31, 2023, our disclosure controls and procedures were not effective because of a material weakness in the design of our internal control over financial reporting related to our accounting for inventories and inventory related transactions which is described in more detail below. | ||||||
| 2022-12-31 | 2023-03-10 | described here | effective | effective | remediated (prior year) | EDGAR |
Item 3 · Legal Proceedings Relating to Vadadustat Opposition Proceedings Against Akebia In September 2018, Dr. Reddy’s Laboratories Limited filed an opposition to our issued Indian Patent No. 287720 in the Indian Patent Office. On July 26, 2022, Sandoz AG filed an opposition against our issued European Patent No. 3277270 in the European Patent Office. On February 13, 2023, FibroGen, Inc., or FibroGen, filed an opposition against our issued European Patent No. 3357911 in the European Patent Office. Proceedings Filed by Akebia Against FibroGen, Inc. Europe We filed an opposition in the European Patent Office, or the EPO, against FibroGen’s European Patent No. 1463823, or the ’823 EP Patent on December 5, 2013, and an oral proceeding took place March 8 and 9, 2016. Following the oral proceeding, the Opposition Division of EPO ruled that the patent as granted did not meet the requirements for patentability under the European Patent Convention and, therefore, revoked the patent in its entirety. FibroGen appealed that decision. On February 27, 2023, FibroGen withdrew its appeal, and the patent remains revoked. On May 13, 2015, May 20, 2015 and July 6, 2015, we filed oppositions to FibroGen’s Euro… Item 9A · ICFR · Based on the assessment, management has concluded that our internal control over financial reporting was effective as of December 31, 2022. Item 9A · disclosure controls · Our Chief Executive Officer and Chief Financial Officer have concluded based upon the evaluation described below that, as of December 31, 2022, our disclosure controls and procedures were effective at the reasonable assurance level. Item 9A · material weakness · Remediation of Previously Identified Material Weakness As disclosed in our 2021 Annual Report on Form 10-K, management identified a material weakness in our internal control over financial reporting relating to our inventory process. | ||||||
| 2021-12-31 | 2022-03-01 | described here | NOT effective | NOT effective | disclosed | EDGAR |
Item 3 · Legal Proceedings Relating to Vadadustat Opposition Proceedings Against Akebia In July 2011, a third party filed an opposition to our issued European Patent No. 2044005, or the ’005 EP Patent, in the European Patent Office, or the EPO. During the oral proceedings, which took place on April 10, 2013, the Opposition Division of the EPO maintained the ’005 EP Patent. This decision resulted in the maintenance of a claim directed to a compound chosen from a group of eight compounds, including vadadustat, as well as claims to compositions and methods for treating various diseases, including, but not limited to, anemia. Both parties appealed the decision of the Opposition Division of the EPO. On February 27, 2018, we withdrew the ’005 EP Patent from appeal and filed a divisional patent application to pursue a focused claim set that includes claims for vadadustat, as well as pharmaceutical compositions and methods of treating anemia. In September 2018, Dr. Reddy’s Laboratories Limited filed an opposition to our issued Indian Patent No. 287720 in the Indian Patent Office. Proceedings Filed by Akebia Against FibroGen, Inc. Europe We filed an opposition in the EPO against FibroGen, Inc.’s, or… Item 9A · ICFR · Based on the assessment, management has concluded that the material weakness in our internal control over financial reporting relating to our inventory process as reported in our Annual Report on Form 10-K for the year ended December 31, 2020 remains un-remediated as of December 31, 2021 and that, our internal control over financial reporting as of December 31, 2021 was not effective due to the following material weakness: the Company did not design and maintain effective controls over the completeness, accuracy, existence and presentation and disclosure of inventory. Item 9A · disclosure controls · Our Chief Executive Officer and Chief Financial Officer have concluded based upon the evaluation described below that, as of December 31, 2021, our disclosure controls and procedures were not effective because of a material weakness in our internal control over financial reporting relating to our inventory process which is described in more detail below. | ||||||
5 of 5 annual reports on record have their filing text cached on this host; the rest are listed with their EDGAR link and no extraction, because this surface never fetches from SEC on a page load.
- Item 3 and Item 9A are located in the filing HTML already cached on this host and read with the same line-anchored item matcher and largest-gap body disambiguation the filing-narrative pass uses for Item 1A and Item 7 — no fetch, no model, no summarization.
- A heading is accepted as a section only when it is not a table-of-contents row (a trailing page number), not a quoted reference in prose, and names its own section; the span must then clear a per-item length band and carry readable text after the heading. Anything that fails a gate is served as 'not extracted' with the reason — never as a default value.
- An effectiveness conclusion is read only from a sentence that names its own control set (disclosure controls and procedures, or internal control over financial reporting) and states an outcome. Conditional sentences — the standard limitations paragraph and forward-looking remediation language — are excluded, because they are hypotheses rather than conclusions.
- When a filing's own sentences disagree — an effective conclusion beside an unremediated material-weakness disclosure, or two conclusions of opposite sign — no verdict is asserted. A wrong 'controls were effective' reading is worse than no reading.
- Every verdict is shown beside the verbatim sentence it was read from. The excerpt is the filing's own words, capped at 1,200 characters; the filing itself is one link away.