What changed in this filing

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Item 1. Legal Proceedings

2022-05-09 compared with 2021-11-04 · 44 added, 153 removed, 134 unchanged (60% of the section changed)

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In particular, these patents do not claim methods of using any of our product candidates for purposes of inhibiting HIF-PH for the treatment of anemia due to chronic kidney disease, or CKD.

While we do not believe these patents will prevent us from commercializing vadadustat for the treatment of anemia due to CKD, we filed these oppositions to provide us and our collaborators with maximum flexibility for developing vadadustat and our pipeline of investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, or HIF-PHI, compounds.

Oppositions to the ’155 EP Patent and the ’153 EP Patent were also filed in the EPO by Glaxo Group Limited, or Glaxo, and by Bayer Intellectual Property GmbH, Bayer Pharma Aktiengesellschaft, and Bayer Animal Health GmbH, or, collectively, Bayer.

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On December 9, 2016, FibroGen filed a notice to appeal the decision to revoke the ’333 EP Patent.

An oral proceeding for the appeal is scheduled for February 2022.

The Board of Appeal held an oral proceeding on this appeal on February 24 and 25, 2022, during which proceeding the '333 EP Patent was maintained in restricted form.

The ‘333 EP patent was originally granted with four independent claims, one of which was found obvious on appeal.

The remaining claims are directed to:

treatment of anemia of chronic disease in subjects having a percent transferrin saturation of less than 20% (claim 1), treatment of anemia that is refractory to treatment with exogenously administered erythropoietin (claim 6), and treatment of iron deficiency (claim 15).

In oral proceedings held on May 29, 2017, regarding the ’155 EP Patent, the European Opposition Division ruled that the ’155 EP Patent as granted did not meet the requirements for patentability under the European Patent Convention and, therefore, revoked the patent in its entirety.

FibroGen filed a notice to appeal the decision to revoke the ’155 EP Patent on May 29, 2017.

An oral proceeding for the appeal is scheduled for February 2022.

Subsequently, in related oral proceedings held on May 31, 2017 and June 1, 2017 for the ’153 EP Patent, the Opposition Division of the EPO maintained the patent after FibroGen significantly narrowed the claims to an indication for which vadadustat is not intended to be developed.

An oral proceeding for the appeal was held on February 22, 2022, during which proceeding the Board of Appeal maintained the revocation of the ‘155 EP Patent in its entirety.

In related oral proceedings held on May 31, 2017 and June 1, 2017 for the ’153 EP Patent, the Opposition Division of the EPO maintained the patent after FibroGen significantly narrowed the claims to an indication for which vadadustat is not intended to be developed.

We and Glaxo separately filed notices to appeal the decision to maintain the ’153 EP Patent on November 9, 2017.

Bayer filed a notice to appeal the decision on November 14, 2017.

Glaxo withdrew its appeal on March 2, 2020 and Bayer withdrew its appeal on June 30, 2021.

An oral proceeding for the appeal is scheduled for February 2022.

Glaxo withdrew its appeal on March 2, 2020 and

Bayer withdrew its appeal on June 30, 2021.

An oral proceeding for the appeal was held on February 21, 2022, during which proceeding the Board of Appeal revoked the ‘153 patent in its entirety.

On April 3, 2019, we filed oppositions to FibroGen’s European Patent Nos.

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Oral proceedings for oppositions to the two patents were held on September 7-8 and 10, 2021.

Following oral proceedings, the Opposition Division

of the EPO maintained certain claims in amended form in the two patents.

We do not expect the Opposition Division’s decision on the two patents to have any effect on our commercialization of vadadustat in Europe.

On February 10, 2020, we filed an opposition to FibroGen’s European Patent No.

2324834, or the ’834 EP Patent, in the EPO requesting the patent to be revoked in its entirety.

On October 19, 2021, FibroGen submitted a request to the Opposition Division to terminate these opposition proceedings and revoke the '834 patent.

On May 21, 2018, we filed a Statement of Claim in Canadian Federal Court to challenge the validity of three of FibroGen’s HIF-related patents in Canada:

CA 2467689, CA 2468083, and CA 2526496.

On June 25, 2020, the parties agreed to dismiss the CA 2467689 patent from the lawsuit.

On February 16, 2021, the parties agreed to dismiss the lawsuit in its entirety.

Following oral proceedings, the Opposition Division of the EPO maintained certain claims in amended form in the two patents.

On January 26, 2022, we filed notice to appeal the Opposition Division’s decision for ’531 EP.

These two patents will expire in December 2022, and we do not expect the Opposition Division’s decision on the two patents to have any effect on our commercialization of vadadustat in Europe.

On June 2, 2014, we filed an invalidity proceeding before the Japan Patent Office, or JPO, against certain claims of FibroGen’s Japanese Patent No.

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On March 11, 2020, the JPO issued a pre-notice of a trial decision for JP5474872, which invalidated all claims except one claim in amended form.

On April 2, 2020, the JPO issued a pre-notice of a trial decision for JP5474741, which invalidated all claims except two claims in amended form.

We expect the JPO to issue a final decision this year.

On April 1, 2022, the JPO issued a final decision for JP4845728, which invalidated all claims except claims directed to the medical use to treat anemia that does not respond to erythropoiesis.

We expect the JPO to issue final decisions for JP5474741 and JP5474872 this year.

We do not believe these decisions will prevent our collaboration partner MTPC from commercializing vadadustat for the treatment of anemia due to CKD in Japan.

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On August 24, 2021, the Court of Appeal issued a judgment, which reversed the Patents Court’s judgment on the invalidity of the ’823 EP Patent (UK) and maintained certain claims of the ’823 EP Patent (UK) and the ’301 EP Patent (UK) in amended form, and which affirmed the Patents Court’s judgment on the invalidity of the ’333 EP Patent (UK), the ’155 EP Patent (UK), and the ’153 EP Patent (UK).

Akebia and Otsuka are seeking permission to appeal to the UK Supreme Court.

We do not expect the UK Court of Appeal’s judgment to have any effect on our commercialization of vadadustat in the UK.

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We and Otsuka filed an opposition to the defendants’ motion on July 2, 2021, and the defendants filed a reply brief on July 16, 2021.

We and Otsuka requested oral argument on the motion on July 23, 2021.

The Court has discretion whether to hear oral argument on the motion.

On April 5, 2022, we voluntarily dismissed, without prejudice, our declaratory judgment complaint against FibroGen and AstraZeneca under Rule 41(a)(1)(A)(i) of the Federal Rules of Civil Procedure.

Legal Proceedings Relating to Auryxia

ANDA Litigation

On October 31, 2018, November 6, 2018, December 24, 2018 and February 4, 2019, Keryx Biopharmaceuticals, Inc., or Keryx, received Paragraph IV certification notice letters regarding Abbreviated New Drug Applications, or ANDAs, submitted to the U.S.

Food and Drug Administration, or FDA, by Lupin Atlantis Holdings SA, or Lupin, Teva Pharmaceuticals USA, Inc., or Teva, Chemo Research S.L., or Chemo, and Mylan Pharmaceuticals Inc., or Mylan, respectively, requesting approval for generic versions of Auryxia tablets (210 mg ferric iron per tablet).

On December 13, 2018, Keryx and its licensors, Panion & BF Biotech, Inc., or Panion, and Chen Hsing Hsu, M.D., filed a complaint for patent infringement against Lupin and Lupin Ltd., or the Lupin Defendants, in the United States District Court for the District of Delaware, or the Delaware District Court, arising from Lupin’s ANDA filing with the FDA.

On December 19, 2018, Keryx and Panion filed a complaint for patent infringement against Teva and Teva Pharmaceutical Industries Limited, or the Teva Defendants, in the Delaware District Court arising from Teva’s ANDA filing with the FDA.

On February 1, 2019, Keryx, Panion and Dr.

Hsu filed a complaint for patent infringement against Chemo and Insud Pharma S.A., or the Chemo Defendants, in the Delaware District Court arising from Chemo’s ANDA filing with the FDA.

On March 15, 2019, Keryx, Panion and Dr.

Hsu filed a complaint for patent infringement against Mylan in the United States District Court for the Northern District of West Virginia arising from Mylan’s ANDA filing with the FDA.

On April 18, 2019, Keryx, Panion and Dr.

Hsu filed a motion with the Judicial Panel on Multidistrict Litigation seeking to consolidate these four cases in the Delaware District Court for pretrial proceedings.

On March 29, 2019, April 2, 2019, and April 12, 2019, Keryx received Paragraph IV certification notice letters regarding ANDAs submitted to the FDA by Lupin Ltd., Watson Laboratories, Inc., or Watson, a wholly-owned, indirect subsidiary of Teva, and Par Pharmaceutical, Inc., or Par, an Endo International company, or Endo, respectively, requesting approval for generic versions of Auryxia tablets (210 mg ferric iron per tablet).

On May 10, 2019, Keryx, Panion and Dr.

Hsu filed a complaint for patent infringement against Lupin Ltd.

in the Delaware District Court arising from Lupin Ltd.’s ANDA filing with the FDA.

On May 10, 2019, Keryx and Panion filed a complaint for patent infringement against Watson and the Teva Defendants, or the Watson Defendants, in the Delaware District Court arising from Watson’s ANDA filing with the FDA.

On May 15, 2019, Keryx and Panion filed a complaint for patent infringement against the Watson Defendants in the United States District Court for the District of Nevada, or the Nevada District Court, from Watson’s ANDA filing with the FDA.

On May 23, 2019, Keryx and Panion filed a complaint for patent infringement against Par in the Delaware District Court arising from Par’s ANDA filing with the FDA.

On May 24, 2019, Keryx and Panion filed a complaint for patent infringement against Par, in the United States District Court for the Southern District of New York, or the Southern New York District Court, arising from Par’s ANDA filing with the FDA.

On June 4, 2019, Keryx and Panion filed a notice of voluntary dismissal to dismiss the suit in the Nevada District Court in view of the Watson Defendants’ consent to venue of the Delaware District Court.

On June 26, 2019, Keryx, Panion and Dr.

Hsu notified the Judicial Panel on Multidistrict Litigation of additional actions in the Delaware District Court against the Lupin Defendants and the Watson Defendants.

On July 31, 2019, the Judicial Panel on Multidistrict Litigation issued an order to consolidate all of our ANDA cases in Delaware District Court for pretrial proceedings.

On August 26, 2019, Keryx filed an amended complaint against the Lupin Defendants in the Delaware District Court arising from the Lupin Defendants’ ANDA filings with the FDA.

On September 19, 2019, the Delaware District Court set a trial date for February 8, 2021.

The trial was rescheduled for June 28, 2021.

On January 13, 2021, the Delaware District Court vacated the deadlines for the case involving Mylan pending resolution of a discovery dispute.

On July 22, 2019, Keryx received from Teva a supplemental Paragraph IV certification notice letter regarding its ANDA.

On July 22, 2019, Keryx received from Watson a supplemental Paragraph IV certification notice letter regarding its ANDA.

On July 31, 2019, Keryx received from Lupin a supplemental Paragraph IV certification notice letter regarding its ANDA.

On July 31, 2019, Keryx received from Lupin Ltd.

a supplemental Paragraph IV certification notice letter regarding its ANDA.

On September 17, 2019, Keryx received from Par a supplemental Paragraph IV certification notice letter regarding its ANDA.

On October 16, 2019, Keryx received from Mylan a supplemental Paragraph IV certification notice letter regarding its ANDA.

On May 14, 2020, Keryx received from Chemo a supplemental Paragraph IV certification notice letter regarding its ANDA.

On April 27, 2020, the Delaware District Court conducted a Markman hearing concerning certain claim construction issues with respect to four Orange Book-listed patents, and issued an order in favor of Keryx.

On August 2, 2019, Keryx and Panion entered into a settlement and license agreement with Par.

This settlement resolved patent litigation brought by Keryx and Panion in response to Par’s ANDA seeking approval to market a generic version of Auryxia tablets prior to the expiration of the applicable patents.

Pursuant to the terms of the settlement, Keryx and Panion granted Par a license to market a generic version of Auryxia in the United States beginning on March 20, 2025 (subject to FDA approval), or earlier under certain circumstances customary for settlement agreements of this nature.

Additionally, in accordance with the

agreement, the parties terminated all ongoing litigation between Keryx and Panion and Par regarding Auryxia patents pending in the Delaware District Court and the Southern New York District Court.

The settlement and license agreement is confidential and subject to review by the U.S.

Federal Trade Commission and the U.S.

Department of Justice.

On August 5, 2019, the parties filed a request to stay the litigation pending a review of the settlement and license agreement by these regulatory authorities.

On September 6, 2019 and September 9, 2019, the Southern New York District Court and the Delaware District Court, respectively, entered a stipulation and order of dismissal filed by the parties to terminate the actions against Par.

On April 30, 2020, Keryx and Panion entered into a settlement and license agreement with Teva and Watson.

This settlement resolved patent litigation brought by Keryx and Panion in response to Teva and Watson’s ANDAs seeking approval to market a generic version of Auryxia tablets prior to the expiration of the applicable patents.

Pursuant to the terms of the settlement, Keryx and Panion granted Teva and Watson a license to market a generic version of Auryxia in the United States beginning on March 20, 2025 (subject to FDA approval), or earlier under certain circumstances customary for settlement agreements of this nature.

Additionally, in accordance with the agreement, the parties terminated all ongoing litigation between Keryx and Panion and Watson and Teva regarding Auryxia patents pending in the Delaware District Court.

The settlement and license agreement is confidential and subject to review by the U.S.

Federal Trade Commission and the U.S.

Department of Justice.

On May 4, 2020, the Delaware District Court entered a stipulation and order of dismissal filed by the parties to terminate the action against Teva and Watson.

On September 24, 2020, Keryx, Panion and Dr.

Hsu entered into a settlement and license agreement with the Lupin Defendants.

This settlement resolved patent litigation brought by Keryx and Panion in response to Lupin and Lupin Ltd.’s ANDAs seeking approval to market a generic version of Auryxia tablets prior to the expiration of the applicable patents.

Pursuant to the terms of the settlement, Keryx and Panion granted Lupin and Lupin Ltd.

a license to market a generic version of Auryxia in the United States beginning on March 20, 2025 (subject to FDA approval), or earlier under certain circumstances customary for settlement agreements of this nature.

Additionally, in accordance with the agreement, the parties terminated all ongoing litigation among Keryx, Panion, the Lupin Defendants and Dr.

Hsu regarding Auryxia patents pending in the Delaware District Court.

The settlement and license agreement is confidential and subject to review by the U.S.

Federal Trade Commission and the U.S.

Department of Justice.

On October 5, 2020, the Delaware District Court entered a stipulation and order of dismissal filed by the parties to terminate the action against the Lupin Defendants.

On March 25, 2021, Keryx and Panion entered into a settlement and license agreement with the Chemo Defendants.

This settlement resolved patent litigation brought by Keryx and Panion in response to Chemo’s ANDA seeking approval to market a generic version of Auryxia tablets prior to the expiration of the applicable patents.

Pursuant to the terms of the settlement, Keryx and Panion granted Chemo a license to market a generic version of Auryxia in the United States beginning on March 20, 2025 (subject to FDA approval), or earlier under certain circumstances customary for settlement agreements of this nature.

Additionally, in accordance with the agreement, the parties terminated all ongoing litigation among Keryx, Panion, and the Chemo Defendants regarding Auryxia patents pending in the Delaware District Court.

The settlement and license agreement is confidential and subject to review by the U.S.

Federal Trade Commission and the U.S.

Department of Justice.

On March 26, 2021, the Delaware District Court entered a stipulation and order of dismissal filed by the parties to terminate the action against the Chemo Defendants.

On September 22, 2021, Keryx, Panion and Dr.

Hsu entered into a settlement and license agreement with Mylan.

This settlement resolved patent litigation brought by Keryx, Panion, and Dr.

Hsu in response to Mylan’s ANDA seeking approval to market a generic version of Auryxia tablets prior to the expiration of the applicable patents.

Pursuant to the terms of the settlement, Keryx, Panion, and Dr.

Hsu granted Mylan a license to market a generic version of Auryxia in the United States beginning on March 20, 2025 (subject to FDA approval), or earlier under certain circumstances customary for settlement agreements of this nature.

Additionally, in accordance with the agreement, the parties terminated all ongoing litigation among Keryx, Panion, Dr.

Hsu, and Mylan regarding Auryxia patents pending in the Delaware District Court and the North District Court of West Virginia.

The settlement and license agreement is confidential and subject to review by the U.S.

Federal Trade Commission and the U.S.

Department of Justice.

On September 28, 2021, the Delaware District Court entered a stipulation and order of dismissal filed by the parties to terminate the action against Mylan.

In 2018 and 2019, Keryx Biopharmaceuticals, Inc., or Keryx, received Paragraph IV certification notice letters regarding Abbreviated New Drug Applications, or ANDAs, submitted to the U.S.

Food and Drug Administration, or FDA, by third parties requesting approval for generic versions of Auryxia tablets (210 mg ferric iron per tablet).

In response to such ANDA filings, Keryx and its licensors, Panion & BF Biotech, Inc., or Panion, and, as applicable, Chen Hsing Hsu, M.D., filed complaints for patent infringement against such third parties.

Keryx, Panion and, as applicable, Dr.

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Hsu, in response to ANDAs filed by third parties seeking approval to market generic versions of Auryxia ® (ferric citrate) tablets prior to the expiration of the applicable patents.

CMS Litigation

On October 15, 2019, we filed a complaint in the United States District Court for the District of Massachusetts, or the Massachusetts District Court, against Centers for Medicare & Medicaid Services, or CMS, the U.S.

Department of Health and Human Services, Alex M.

Azar II in his official capacity as Secretary of Health and Human Services, and Seema Verma in her

official capacity as administrator for CMS challenging CMS’s decision that Auryxia would no longer be covered by Medicare for the treatment of iron deficiency anemia, or IDA, in adult patients with CKD not on dialysis, or the IDA Indication, and imposing a prior authorization requirement for Auryxia in the treatment of adult patients with CKD on dialysis, or the Hyperphosphatemia Indication.

On October 29, 2019, we filed a motion for a preliminary injunction asking the court to provide relief while the lawsuit is pending, specifically, to restore coverage of Auryxia for the IDA Indication, and to remove the prior authorization requirement for Auryxia for the Hyperphosphatemia Indication.

In the alternative, we filed a motion for summary judgment with the court asking it to decide the case on the merits.

On February 4, 2020, the court denied our request for a preliminary injunction.

We filed an expedited appeal with the Court of Appeals for the First Circuit challenging the District Court’s denial of our motion for a preliminary injunction.

The First Circuit Court of Appeals held oral argument on August 14, 2020, and affirmed the District Court’s denial of our request for a preliminary injunction on September 30, 2020.

We then attempted to reach a settlement with CMS, but we were unsuccessful in these efforts.

On October 22, 2021, the parties agreed to dismiss the litigation.

As a result, Auryxia remains not covered by Medicare for the IDA Indication and the prior authorization requirement for Auryxia for the Hyperphosphatemia Indication also remains in place.

Shareholder Litigation Relating to Auryxia Supply

Four putative class action lawsuits were filed against Keryx, and certain of its former officers (Gregory P.

Madison, Scott A.

Holmes, Ron Bentsur, and James Oliviero) and consolidated in the Massachusetts District Court, captioned Karth v.

Keryx Biopharmaceuticals, Inc., et al.

(filed October 26, 2016, with an amended complaint filed on February 27, 2017).

Plaintiff sought to represent all stockholders who purchased shares of Keryx common stock between May 8, 2013 and August 1, 2016.

The complaint alleges that Keryx and the named individual defendants violated Sections 10(b) and/or 20(a) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements concerning Keryx, its supplier relationships, and future prospects, and that the allegedly misleading statements were not made known to the market until Keryx’s August 1, 2016 announcement of an interruption in its supply of Auryxia.

On September 23, 2019, the Massachusetts District Court issued a Memorandum and Order denying plaintiff’s motion for class certification, granting defendants’ motion for judgment on the pleadings, and denying plaintiff’s motion for leave to further amend his Complaint.

That same day, the Massachusetts District Court entered a final judgment in favor of defendants on all claims.

On September 24, 2019, plaintiff filed a notice of appeal.

On June 21, 2021, the First Circuit affirmed the District Court’s judgment in its entirety.

The time for plaintiff to seek a rehearing before the First Circuit has now lapsed.

Plaintiff has until November 18, 2021 to file a petition for certiorari to the United States Supreme Court to the extent Plaintiff wishes to seek any further appellate review.

Two stockholder derivative complaints also were filed on December 16, 2016 against Keryx and certain of its former officers (Gregory P.

Madison, Scott A.

Holmes, Ron Bentsur and James Oliviero) certain of its former directors (Kevin J.

Cameron, Daniel P.

Regan, Steven C.

Gilman, Michael Rogers Michael P.

Tarnok, Joseph Feczko, Jack Kaye Wyche Fowler, Jr.

Butler), some of whom are current directors and officers of ours, in the Superior Court of Massachusetts, one captioned Venkat Vara Prasad Malledi v.

Keryx Biopharmaceuticals, Inc., et al., and one captioned James Anderson v.

Keryx Biopharmaceuticals, Inc., et al.

Each of these two complaints generally alleged breach of fiduciary duty, unjust enrichment, abuse of control, mismanagement and corporate waste.

On June 27, 2017, the Superior Court of Massachusetts granted the parties’ motion to consolidate and stay the derivative litigations pending the outcome of the federal securities litigation.

On July 15, 2021, the plaintiffs in these actions filed a Notice of Dismissal, without prejudice, of all claims.

Shareholder Litigation Relating to the Merger

Each settlement agreement granted the defendants a license to market a generic version of Auryxia in the United States beginning on March 20, 2025 (subject to FDA approval), or earlier under certain circumstances customary for settlement agreements of this nature.

Stockholder Litigation Relating to the Merger

On June 28, 2018, we entered into an Agreement and Plan of Merger with Keryx and Alpha Therapeutics Merger Sub, Inc., or the Merger Sub, pursuant to which the Merger Sub would merge with and into Keryx, with Keryx becoming a wholly owned subsidiary of ours, or the Merger.

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The Second Consolidated Complaint (i) asserts the same claims under the Exchange Act as the Consolidated Complaint, (ii) names the same defendants as the Consolidated Complaint, (iii) seeks the same relief as the Consolidated Complaint and (iv) as with the Consolidated Complaint, challenges as false or misleading alleged misstatements or omissions related to certain financial projections for Keryx and Akebia and certain financial analyses performed by our advisors.

The defendants in the Consolidated Federal Action moved to dismiss the Second Consolidated Amended Complaint in its entirety with prejudice on August 10, 2020.

On April 1, 2021, the Delaware District Court granted the defendants’ motion and dismissed the Second Consolidated Complaint in its entirety.

On April 29, 2021, lead plaintiffs filed a notice of appeal in the United States Court of Appeals for the Third Circuit.

Briefing on the appeal was completed on October 7, 2021.

The defendants in the Consolidated Federal Action moved to dismiss the Second Consolidated Complaint in its entirety with prejudice on August 10, 2020.

Briefing on defendants’ motion to dismiss was completed on

October 7, 2021, and the Third Circuit submitted the case on the briefs without oral argument on February 10, 2022.

The decision is currently pending.

On July 15, 2021, a purported former Keryx stockholder filed a putative class action in the Supreme Court of the State of New York against Akebia, a current officer of Akebia (John P.

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Akebia Therapeutics, Inc., et al., or the Panicho Action.

On October 15, 2021, the Supreme Court of the State of New York entered a joint stipulation and order consolidating the Loper Action and Panicho Action under the caption In re Akebia Therapeutics, Inc.

Securities Litigation, or the Consolidated State Action, providing for the filing of a consolidated complaint in the Consolidated State Action by October 27, 2021, and providing for briefing to be completed on any motion to dismiss such consolidated complaint by March 28, 2022.

The consolidated complaint was filed on October 27, 2021.

We deny any allegations of wrongdoing and intend to continue vigorously defending against the shareholder lawsuits described in this Legal Proceedings section.

On September 13, 2021, the parties in the Loper Action and Panicho Action entered into a joint stipulation and proposed order, which provided for the consolidation of the two actions under the caption In re Akebia Therapeutics, Inc.

Securities Litigation, or the Consolidated State Action.

On October 27, 2021, plaintiffs filed a consolidated complaint in the Consolidated State Action.

On January 10, 2022, defendants moved to dismiss the consolidated complaint in its entirety.

Briefing on defendants’ motion to dismiss was completed on April 22, 2022.

Oral arguments have not yet been scheduled.

On March 14, 2022, a purported stockholder of Akebia filed a putative federal securities class action against Akebia as well as three present and former officers of Akebia (John P.

Butler, David A.

Spellman, and Jason A.

Amello) in the U.S.

District Court for the Eastern District of New York.

The action is captioned Deputy v.

Akebia Therapeutics, Inc., et al., No.

1:22-cv-01411, or the EDNY Action.

The complaint in the EDNY Action alleges that defendants made materially false and misleading statements in violation Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.

The alleged false and misleading statements relate to the safety, approvability, and commercial viability of vadadustat.

The complaint in the EDNY Action seeks damages including interest thereon, an award of plaintiffs’ and the class’s costs and expenses, including counsel fees and expert fees, or such other and further relief that the Court deems appropriate.

We deny any allegations of wrongdoing and intend to continue vigorously defending against the stockholder lawsuits described in this Legal Proceedings section.

There is no assurance, however, that we will be successful in the defense of these lawsuits, or any associated appeals, or that insurance will be available or adequate to fund any settlement or judgment or the litigation costs of these actions.

2 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Legal Proceedings