AKBA on Nasdaq

Akebia Therapeutics, Inc.

In its 2026 annual report the company says: “We are a fully integrated biopharmaceutical company with two commercial products for patients impacted by kidney disease. We have established the Company as a leader in the kidney community and believe our cross-organizational expertise in kidney disease positions us for success.”5 It is headquartered in Cambridge, United States.2 Its shares trade on Nasdaq under the symbol AKBA.2

$0.71 up 0.00 (0.56%)Price as of Oct 15, 2026 at 17:33 UTC

Last updated Oct 21, 2026.

Overview

Compare with ANAPTYSBIO, INC, Keros Therapeutics, Inc. or Puma Biotechnology, or pick any stock.

  • TickerAKBA on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersCambridge, United States2
  • Incorporated inDE4
  • Business address180 Third Avenue, Floor 2, Waltham, Ma 024514
  • Filer categoryLarge accelerated filer4
  • Legal formCorporation2
  • LEI549300CBQEHMKEEGNX422
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O THE CORPORATION TRUST COMPANY, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 43080992

We are a fully integrated biopharmaceutical company with two commercial products for patients impacted by kidney disease. We have built a business focused on developing and commercializing innovative therapeutics that we believe serve as a foundation for future growth, including by contributing net product revenue to support the development and advancement of our robust pipeline of mid-stage programs targeting rare kidney diseases and early-stage programs targeting kidney disease and non-kidney focused indications.5 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

9.9%Operating margin6
-2.3%Net margin6
47.5%Revenue growth, 20256
-16.4%Return on equity6
1.48×Debt to equity6
$67.7MFree cash flow6

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Auryxia brought in 77% of the revenue Akebia Therapeutics, Inc. broke down this way in fiscal 2025.

  1. Auryxia$181.5M677%up 19% from 2024
  2. Vafseo$45.8M619%
  3. License Collaboration And Other Revenue$8.9M64%up 11% from 2024
Products and services by year
Products and services202320242025
Auryxia$170.3M$152.2M$181.5M
Vafseo$0$0$45.8M
License Collaboration And Other Revenue$24.3M$8.0M$8.9M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue17¢$39.5M
  • Research and development26¢$62.4M
  • Selling, general and admin46¢$107.5M
  • Other costs11¢$25.3M
  • Income tax1¢$1.6M

Out of $236.2M in revenue.6 The company lost money this year.

Where each dollar of operating cash went, fiscal 2025

  • Capital spending0¢$291.0K
  • Kept or used elsewhere100¢$67.7M

Out of $68.0M of cash from operations.6

Financial statements

Revenue7896$236.2M in 2025−29% since 2019
0$100.0M$200.0M$300.0M$400.0M2019: $335.0M$335.0M20192020: $294.6M$294.6M2020−12%2021: $211.7M$211.7M2021−28%2022: $292.5M$292.5M2022+38%2023: $194.6M$194.6M2023−33%2024: $160.2M$160.2M2024−18%2025: $236.2M$236.2M2025+47%
Operating income7896$23.5M in 2025
-$400.0M-$200.0M0$200.0M2019: -$286.3M-$286.3M20192020: -$377.8M-$377.8M2020+32%2021: -$264.5M-$264.5M2021−30%2022: -$80.8M-$80.8M2022−69%2023: -$46.3M-$46.3M2023−43%2024: -$50.5M-$50.5M2024+9%2025: $23.5M$23.5M2025
Net income781096-$5.3M in 2025−98% since 2019
-$400.0M-$300.0M-$200.0M-$100.0M02019: -$279.7M-$279.7M20192020: -$384.8M-$384.8M2020+38%2021: -$282.0M-$282.0M2021−27%2022: -$94.2M-$94.2M2022−67%2023: -$51.9M-$51.9M2023−45%2024: -$69.4M-$69.4M2024+34%2025: -$5.3M-$5.3M2025−92%

Every line of the income statement as filed: the last 3 fiscal years, latest first.6

Period ending2025-12-312024-12-312023-12-31
Total revenues$236.2M$160.2M$194.6M
Cost of product and other revenue$39.5M$27.1M$38.1M
Amortization of intangible asset$0$36.0M$36.0M
Total cost of goods sold$39.5M$63.2M$74.1M
Research and development$62.4M$37.7M$63.1M
Selling, general and administrative$107.5M$106.5M$100.2M
License$3.4M$3.2M$3.2M
Restructuring$0$58.0K$181.0K
Total operating expenses$173.2M$147.5M$166.7M
Income (loss) from operations$23.5M-$50.5M-$46.3M
Interest expense-$24.2M-$18.2M-$6.0M
Other income$58.0K$94.0K$887.0K
Change in fair value of warrant liability-$3.1M-$330.0K$0
Loss on extinguishment of debt$0-$517.0K$0
Loss on termination of lease$0$0-$524.0K
Loss before income taxes-$3.7M-$69.4M-$51.9M
Income tax expense-$1.6M$0$0
Net loss-$5.3M-$69.4M-$51.9M
Comprehensive loss-$5.3M-$69.4M-$51.9M
Basic (in dollars per share)-$0.02-$0.33-$0.28
Diluted (in dollars per share)-$0.02-$0.33-$0.28
Basic (in shares)257.2M shares210.9M shares187.5M shares
Diluted (in shares)257.2M shares210.9M shares187.5M shares

Compare Akebia Therapeutics, Inc. with another company

Corporate structure

Akebia Therapeutics, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Akebia Therapeutics, Inc.

  • State Street Corporation Filed SCHEDULE 13G on Akebia Therapeutics, Inc., latest May 12, 2026 (4 filings since Feb 10, 2022)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Akebia Therapeutics, Inc., latest Mar 26, 2026 (6 filings since Feb 9, 2022)
  • BlackRock Filed SCHEDULE 13G/A on Akebia Therapeutics, Inc., latest Jan 21, 2026 (6 filings since Feb 7, 2022)
  • Muneer A. Satter Filed SCHEDULE 13G/A on Akebia Therapeutics, Inc., latest Feb 14, 2025 (4 filings since Dec 19, 2022)
  • Akebia Therapeutics, Inc. Cambridge, Massachusetts, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Akebia Therapeutics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, net$1.2M6 Dec 31, 2025$2.2M6 Dec 31, 2024−44.5%
Operating-lease assets (leased space)$3.7M6 Dec 31, 2025$8.2M6 Dec 31, 2024−55.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$184.8M6 Dec 31, 2025$51.9M6 Dec 31, 2024+256.4%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$59.0M6 Dec 31, 2025$59.0M6 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$014 Dec 31, 2024$36.0M14 Dec 31, 2023−100.0%

Inventory

ItemLatestA year beforeChange
Inventory, total$15.6M6 Dec 31, 2025$16.2M6 Dec 31, 2024−3.9%

Properties, in its own words

We currently lease approximately 65,167 square feet of office, storage and laboratory space in Cambridge, Massachusetts, which is our corporate headquarters. The lease for our Cambridge, Massachusetts office, storage and lab space expires on September 11, 2026. On January 27, 2026, we entered into a lease agreement pursuant to which we will lease an aggregate of approximately 43,474 square feet, consisting of 28,518 square feet of office space, and 14,956 square feet of laboratory space, in Waltham, Massachusetts. We intend to relocate our corporate headquarters to Waltham in September 2026. We believe our existing facilities are adequate to meet our operational needs.

Item 2 of the 10-K filed Feb 26, 2026.5

Leadership

Who has led Akebia Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (34)

Timeline

  1. Oct 14, 20268-K Executive or director change54
  2. Aug 5, 20268-K Results of operations55
  3. Jun 30, 20268-K Regulation FD disclosure; Other events56
  4. Jun 22, 20268-K Shareholder vote57
  5. May 7, 20268-K Results of operations58
  6. Apr 1, 20268-K Executive or director change59
  7. Feb 26, 20268-K Results of operations60
  8. Jan 30, 20268-K Entered a material agreement; New debt or obligation; Executive or director change61
  9. Jan 12, 20268-K Results of operations; Regulation FD disclosure62
  10. Dec 1, 20258-K Entered a material agreement; Regulation FD disclosure; Other events63
  11. Nov 17, 20258-K Entered a material agreement64
  12. Nov 10, 20258-K Results of operations65
  13. Mar 27, 2014New chief executive John P. Butler becomes CEO15
  14. Feb 27, 2007Founded Akebia Therapeutics, Inc. is founded2

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/202666

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results55
  2. May 7, 2026Reported quarterly or annual results58
  3. Feb 26, 2026Reported quarterly or annual results60
  4. Jan 12, 2026Reported quarterly or annual results62
  5. Nov 10, 2025Reported quarterly or annual results65
  6. Aug 7, 2025Reported quarterly or annual results67
  7. May 8, 2025Reported quarterly or annual results68
  8. Mar 13, 2025Reported quarterly or annual results69

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

328 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 87 major events, 123 insider forms, 20 large holders, 77 other. The latest 20:

  1. Oct 14, 20268-K EDGAR
  2. Aug 10, 20264 PRIMARY DOCUMENT EDGAR
  3. Aug 5, 202610-Q EDGAR
  4. Aug 5, 20268-K EDGAR
  5. Aug 5, 2026S-8 EDGAR
  6. Jul 1, 20264 PRIMARY DOCUMENT EDGAR
  7. Jun 30, 20268-K EDGAR
  8. Jun 29, 2026144 EDGAR
  9. Jun 22, 20264 PRIMARY DOCUMENT EDGAR
  10. Jun 22, 20264 PRIMARY DOCUMENT EDGAR
  11. Jun 22, 20264 PRIMARY DOCUMENT EDGAR
  12. Jun 22, 20268-K EDGAR
  13. Jun 22, 20264 PRIMARY DOCUMENT EDGAR
  14. Jun 22, 20264 PRIMARY DOCUMENT EDGAR
  15. Jun 22, 20264 PRIMARY DOCUMENT EDGAR
  16. May 12, 2026SCHEDULE 13G EDGAR
  17. May 7, 202610-Q EDGAR
  18. May 7, 20268-K EDGAR
  19. Apr 29, 2026ARS EDGAR
  20. Apr 28, 2026DEFA14A EDGAR

The 328 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

60 open-market trades by officers, directors and large owners since October 2021: 1 buys and 59 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 29, 2026Ostrowski ErikSVP, CFO, CBO & TreasurerSale56,019$1.11$62.2KForm 4
Mar 4, 2026Butler John P.CEO and PresidentBuy69,270$1.25$86.6KForm 4
Feb 2, 2026Rucci Carolyn M.SVP, Chief Legal OfficerSale69,772$1.39$97.0KForm 4
Feb 2, 2026Malabre Richard CSVP, Chief Accounting OfficerSale49,524$1.39$68.8KForm 4
Feb 2, 2026Ostrowski ErikSVP, CFO, CBO & TreasurerSale34,951$1.39$48.6KForm 4
Feb 2, 2026Grund NicholasChief Commercial OfficerSale84,829$1.39$117.9KForm 4
Feb 2, 2026Burke Steven KeithSVP, Chief Medical OfficerSale67,658$1.39$94.0KForm 4
Feb 2, 2026Butler John P.CEO and PresidentSale341,305$1.39$474.4KForm 4
Jun 30, 2025Ostrowski ErikSVP, CFO, CBO & TreasurerSale41,314$3.67$151.6KForm 4
Jun 9, 2025Malabre Richard CSVP, Chief Accounting OfficerSale15,000$4.01$60.1KForm 4
Jun 4, 2025Malabre Richard CSVP, Chief Accounting OfficerSale13,334$3.53$47.1KForm 4
Mar 3, 2025Butler John P.CEO and PresidentSale46,409$1.83$84.9KForm 4
Mar 3, 2025Burke Steven KeithSVP, Chief Medical OfficerSale7,144$1.83$13.1KForm 4
Feb 3, 2025Butler John P.CEO and PresidentSale144,250$2.10$302.9KForm 4
Feb 3, 2025Burke Steven KeithSVP, Chief Medical OfficerSale50,506$2.10$106.1KForm 4
Feb 3, 2025Malabre Richard CSVP, Chief Accounting OfficerSale30,202$2.10$63.4KForm 4
Feb 3, 2025Grund NicholasChief Commercial OfficerSale55,621$2.10$116.8KForm 4
May 13, 2024Hadas Nicole R.SVP, Chief Legal OfficerSale12,016$1.26$15.1KForm 4
May 13, 2024Dahan MichelSVP, Chief Operating OfficerSale34,840$1.26$43.9KForm 4
Feb 29, 2024Dahan MichelSVP, Chief Operating OfficerSale8,661$1.58$13.7KForm 4

All 60 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025John P. ButlerPresident and Chief Executive Officer61$864.0K$5.7M74
2025Steven K. BurkeM.D., Senior Vice President, Chief Research & Development and Medical Officer65$600.5K$1.9M74
2025Erik J. OstrowskiSenior Vice President, Chief Financial Officer, Chief Business Officer and Treasurer53$552.9K$1.8M74
2025Nicholas P. GrundSenior Vice President, Chief Commercial Officer56$506.7K$1.7M74
2024John P. ButlerPresident and Chief Executive Officer61$834.0K$4.3M74
2024Nicholas P. GrundSenior Vice President, Chief Commercial Officer56$459.4K$1.9M74
2024Steven K. BurkeM.D., Senior Vice President, Chief Research & Development and Medical Officer65$579.7K$1.8M74
2024Erik J. OstrowskiSenior Vice President, Chief Financial Officer, Chief Business Officer and Treasurer53$284.4K$1.2M74
2023John P. ButlerPresident and Chief Executive Officer61$795.7K$2.8M74
2023Steven K. BurkeM.D., Senior Vice President, Chief Research & Development and Medical Officer65$553.1K$1.2M74

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.19,986,374$22.8M0.0%+1,293,078
Vanguard Capital Management LLC11,322,143$12.9M0.0%+155,433
Aqr Capital Management LLC9,151,524$10.4M0.0%+7,358,904
Geode Capital Management, LLC6,727,302$7.7M0.0%+275,050
State Street Corp5,390,853$6.1M0.0%−6,223,153
Jacobs Levy Equity Management, Inc4,273,026$4.9M0.0%+3,843,357
Nantahala Capital Management, LLC4,000,000$4.6M0.1%+2,000,000
Goldman Sachs Group Inc3,689,167$4.2M0.0%+86,340
Millennium Management LLC3,196,605$3.6M0.0%+811,892
Vanguard Portfolio Management LLC2,533,977$2.9M0.0%+318,536
Two Sigma Investments, LP2,436,673$2.8M0.0%+1,138,872
Charles Schwab Investment Management Inc2,300,438$2.6M0.0%+284,861
Northern Trust Corp2,160,365$2.5M0.0%+214,779
Vanguard Fiduciary Trust Co1,908,797$2.2M0.0%+129,496
Fmr LLC1,871,059$2.1M0.0%+535,731
Qube Research & Technologies Ltd1,779,707$2.0M0.0%−615,508
Citadel Advisors LLC1,717,659$2.0M0.0%+327,592
UBS Group AG1,374,950$1.6M0.0%+605,479
Renaissance Technologies LLC1,223,963$1.4M0.0%−609,165
Citigroup Inc1,124,570$1.3M0.0%−1,730,016
Hennion & Walsh Asset Management, Inc.839,729$957.3K0.0%+206,476
Morgan Stanley701,540$799.8K0.0%+120,213
Invesco Ltd.694,928$792.2K0.0%−25,211
Mangrove Partners Im, LLC666,954$760.3K0.0%+291,000
Ameriprise Financial Inc626,160$713.8K0.0%+615,769

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Akebia Therapeutics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARAkebia Therapeutics, Inc.1
  • CIK0001517022
  • Employer ID (EIN)20-87569035
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address180 Third Avenue, Floor 2, Waltham, MA 024511
  • Phone617-871-20981
  • Shares outstanding277,106,245 as of Jul 31, 202612
  • Public float$946.4M as of Jun 30, 20255
  • AuditorErnst & Young LLP, Boston, Massachusetts PCAOB ID 42; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceApr 8, 20111
  • Filings883 in all: 4 (326), 8-K (164), 3 (42), 10-Q (38), SC 13G/A (37), 144 (28), 425 (25), DEFA14A (22)1
    All 51 form types

    CT ORDER (20), SC 13G (19), 424B5 (17), S-8 (16), DEF 14A (13), 10-K (12), CORRESP (12), UPLOAD (11), 4/A (8), SC 13D/A (7), EFFECT (6), 8-K/A (5), SC 13D (5), ARS (4), S-1/A (4), SCHEDULE 13G/A (4), PRE 14A (3), S-3 (3), SCHEDULE 13G (3), 5 (2), FWP (2), S-3ASR (2), S-4/A (2), SEC STAFF LETTER (2), 10-K/A (1), 424B3 (1), 424B4 (1), 8-A12B (1), CERTNAS (1), D (1), D/A (1), DEFR14A (1), DRS (1), DRS/A (1), NT 10-K (1), NT 10-Q (1), POS AM (1), POSASR (1), PRER14A (1), S-1 (1), S-1MEF (1), S-3/A (1), S-4 (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Oct 14, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.00001 par value per shareAKBANasdaq

From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Akebia Therapeutics, Inc. names in Item 1A of its 10-K filed Feb 26, 2026: 61 risks under these headings, as written.5

  • We face a variety of risks and uncertainties in our business. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also become important factors that affect our business, reputation, results of operations, financial condition and stock price which can be materially and adversely affected. If any of the following risks occurs, our business, financial condition, financial statements, results of operations and future growth prospects could be materially and adversely affected.
  • Risks Related to our Financial Position, Need for Additional Capital and Growth Strategy
  • We have incurred significant losses since our inception, and anticipate that we will continue to incur losses and cannot guarantee when, if ever, we will become and remain profitable.
  • We may require substantial additional financing to fund our business. A failure to obtain this necessary capital when needed, or on acceptable terms, could force us to delay, limit, reduce or terminate our product development or commercialization efforts.
  • Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our products and product candidates on unfavorable terms to us.
  • We may not be successful in our efforts to identify, acquire, in-license, discover, develop and commercialize additional products or product candidates or our decisions to prioritize the development of certain product candidates over others may not be successful, which could impair our ability to grow.
  • We may engage in strategic transactions to acquire assets, businesses, or rights to products, product candidates or technologies or form collaborations or make investments in other companies or technologies that could harm our operating results, dilute our stockholders’ ownership, increase our debt, or cause us to incur significant expense.
  • Risks Related to our Financial Arrangements
  • Our obligations in connection with the BlackRock Credit Agreement and requirements and restrictions in the BlackRock Credit Agreement could adversely affect our financial condition and restrict our operations.
  • Our Royalty Interest Acquisition Agreement with HealthCare Royalty Partners IV, L.P. contains various covenants and other provisions, which, if violated, could materially adversely affect our financial condition.
  • Risks Related to Commercialization
  • Our business is substantially dependent on the commercial success of Auryxia and Vafseo. If we are unable to continue to successfully commercialize Auryxia and Vafseo, our results of operations and financial condition will be materially harmed.
The other 52 risks
  • If we are unable to maintain sales and marketing capabilities or enter into or maintain agreements with third parties, we may not be successful in commercializing Auryxia, Vafseo or any other product candidates that may be approved.
  • Our, or our partners', failure to obtain or maintain adequate coverage, pricing and reimbursement for Auryxia, Vafseo or any other future approved products, could have a material adverse effect on our or our collaboration partners’ ability to sell such approved products profitably and otherwise have a material adverse impact on our business.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before, or more successfully than, we do.
  • The commercialization of ferric citrate, branded as Riona in Japan, Vafseo in Europe, Japan and other territories where it is approved, and our current and potential future efforts with respect to the development and commercialization of our products and product candidates outside of the U.S. subject us to a variety of risks associated with international operations, which could materially adversely affect our business.
  • Risks Related to Product Development
  • Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and we will incur additional costs in connection with, and may experience delays in completing, or ultimately be unable to complete, the development of any of our product candidates.
  • We may find it difficult to enroll patients in our clinical trials, which could delay or prevent clinical trials of Auryxia, Vafseo or any other product or product candidate, including those that may be in-licensed or acquired.
  • We have conducted and intend to conduct certain of our clinical trials globally. However, there are additional risks unique to conducting trials outside of the U.S., and the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans may be delayed, which could materially harm our business.
  • Auryxia, Vafseo or any other product or product candidate, including those that may be in-licensed or acquired, may cause undesirable side effects or have other properties that may delay or prevent marketing approval or limit their commercial potential.
  • Risks Related to Regulatory Approval
  • We may not be able to obtain marketing approval for any potential label expansion for Vafseo or any current or future product candidate, or we may experience significant delays in doing so, any of which would materially harm our business.
  • We may not be able to obtain orphan drug exclusivity for praliciguat or any potential future product candidates that we may develop, and even if we do, that exclusivity may not prevent the FDA or the EMA from approving other competing products.
  • If we are unable to obtain or maintain marketing approval in jurisdictions outside the United States, we and our partners will not be able to market any of our products or product candidates outside of the United States.
  • Products approved for marketing are subject to extensive post-marketing regulatory requirements, including post-approval pediatric studies for Auryxia and Vafseo, and could be subject to post-marketing restrictions or withdrawal from the market, and we may be subject to penalties, including withdrawal of marketing approval, if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, or product candidates, when and if approved.
  • Risks Related to Governmental Regulation and Compliance
  • We are subject to complex regulatory schemes that require significant resources to ensure compliance and our failure to comply with applicable laws could subject us to government scrutiny or enforcement, potentially resulting in costly investigations, fines, penalties or sanctions, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
  • We will incur significant liability if it is determined that we are promoting any “off-label” use of Auryxia, Vafseo or any other product we may develop, in-license or acquire or we are found to have improperly promoted such products through direct-to-consumer advertising, or if it is determined that any of our activities violates the federal Anti-Kickback Statute.
  • Disruptions at the FDA and other government agencies from funding cuts, personnel losses, regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development program and develop and secure approval of our product candidates in a timely manner, which would negatively impact our business.
  • Compliance with privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and the failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
  • Legislative and regulatory healthcare reform may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain for any products that are approved in the U.S. or foreign jurisdictions.
  • Our reporting and payment obligations under the Medicaid Drug Rebate Program, Medicare and other governmental drug pricing programs are complex and may involve subjective decisions. Any failure to properly comply with those obligations could subject us to penalties and sanctions.
  • With the passage of the CREATES Act, we are exposed to possible litigation and damages by competitors who may claim that we are not providing sufficient quantities of our approved products on commercially reasonable, market-based terms for testing in support of their ANDAs, 505(b)(2) NDAs and biosimilar product applications.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.
  • Risks Related to our Reliance on Third Parties
  • We depend on collaborations with third parties for the development and commercialization of Auryxia, an authorized generic version of Auryxia, Riona and Vafseo. If these collaborations are not successful or if our collaborators terminate their agreements with us, we may not be able to capitalize on the market potential of Auryxia, Riona and Vafseo, and our business could be materially harmed.
  • We may seek to establish additional collaborations and, if we are not able to establish them on commercially reasonable terms, or at all, we may have to alter our development and commercialization plans.
  • Royalties from commercial sales of Vafseo under our TPC Agreement will likely fluctuate and will impact our rights to receive future payments under our Royalty Agreement with HCR.
  • We rely upon third parties to conduct all aspects of our product manufacturing and commercial distribution, and in many instances only have a single supplier or distributor, and the loss of these manufacturers or distributors, their failure to
  • supply us on a timely basis, or at all, or their failure to successfully carry out their contractual duties or comply with regulatory requirements, cGMP requirements or guidance could cause delays in or disruptions to our supply chain and substantially harm our business.
  • We rely upon third parties to conduct our clinical trials and certain of our preclinical studies. If they do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain or maintain marketing approval for Auryxia, Vafseo or any of our product candidates, and our business could be substantially harmed.
  • If the licensor of certain intellectual property relating to Auryxia terminates, modifies or threatens to terminate existing contracts or relationships with us, our business may be materially harmed.
  • Manufacturing biologics is complex, and we may experience manufacturing problems that result in delays in our AKB-097 development program or other product candidates.
  • Changes in and uncertainty surrounding U.S. trade policy on tariffs could have a material adverse impact on our business, financial condition and results of operations.
  • Changes in the geopolitical environment, including U.S. and international trade policies, particularly with respect to China, Europe or Canada, may adversely impact our business and operating results.
  • Risks Related to our Intellectual Property
  • If we are unable to adequately protect our intellectual property, third parties may be able to use our intellectual property, which could adversely affect our ability to compete in the market.
  • We may not be able to protect our intellectual property rights throughout the world.
  • The intellectual property that we own or have licensed and related non-patent exclusivity relating to our current and future products is, and may be, limited, which could adversely affect our ability to compete in the market and adversely affect the value of Auryxia, Vafseo or other future products.
  • The market entry of one or more generic competitors or any third party’s attempt to challenge our intellectual property rights will likely limit Auryxia and Vafseo sales and have an adverse impact on our business and results of operation.
  • Litigation and administrative proceedings, including third party claims of intellectual property infringement and opposition/invalidation proceedings against third party patents, may be costly and time consuming and may delay or harm our drug discovery, development and commercialization efforts.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
  • Risks Related to our Business and Managing Growth
  • If we fail to attract, retain and motivate senior management and qualified personnel, we may be unable to successfully develop and commercialize Auryxia, Vafseo or any of our product candidates.
  • We may encounter difficulties in managing our growth, including with respect to our employee base, and managing our partnerships and operations successfully.
  • We previously identified a material weakness in our internal control over financial reporting, which has been remediated. If we identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately or timely report our financial results or prevent fraud, and we may conclude that our internal control over financial reporting is not effective, which may adversely affect our business.
  • Our employees, independent contractors, principal investigators, CROs, CMOs, consultants and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading. In addition, laws and regulations governing any international operations we have or may have in the future may require us to develop and implement costly compliance programs.
  • Our financial statements include long-lived assets, including goodwill as a result of the Merger. Other long-lived assets, including property and equipment, right-of-use assets or goodwill, could become impaired in the future under certain conditions. Any potential future impairment of property and equipment, our right-of-use assets or goodwill may significantly impact our results of operations and financial condition.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of Auryxia or Vafseo or affect the development of our product candidates.
  • We will continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to compliance initiatives and corporate governance practices.
  • Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
  • Our ability to use net operating losses to offset future taxable income may be subject to certain limitations.
  • Our Charter designates the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • Risks Related to our Common Stock
  • Our stock price has been and may continue to be volatile, which could result in substantial losses for holders or future purchasers of our common stock and lawsuits against us and our officers and directors and could result in substantial costs and divert management's attention.
  • If we fail to comply with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
  • The issuance of additional shares of our common stock or the sale of shares of our common stock by any of our directors, officers or significant stockholders will dilute our stockholders’ ownership interest in Akebia and may cause the market price of our common stock to decline.
  • Our executive officers, directors and principal stockholders maintain the ability to significantly influence all matters submitted to stockholders for approval.
  • Provisions in our organizational documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders, and may prevent attempts by our stockholders to replace or remove our current management.
  • Because we do not anticipate paying any cash dividends on our capital in the foreseeable future, capital appreciation, if any, will be our stockholders’ sole source of gain.

Legal proceedings

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 cancelled and the procedure will be continued in writing. On January 15, 2026, the EPO issued a decision to discontinue the opposition proceedings.

The opening of Item 3, Legal Proceedings.5

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