ZVRA on Nasdaq

ZEVRA THERAPEUTICS, INC.

In its 2026 annual report the company says: “We are a commercial-stage company with a late-stage pipeline committed to redefining what is possible in bringing life-changing therapies to people living with rare diseases. We are focused on expanding patient access, progressing our pipeline toward key milestones, and delivering meaningful therapeutics.”5 It is headquartered in Celebration, United States.2 Its shares trade on Nasdaq under the symbol ZVRA.2

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Last updated Oct 21, 2026.

Overview

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  • TickerZVRA on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersCelebration, United States2
  • Incorporated inDE3
  • Business address101 Federal Street, Boston, Ma 021103
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI254900CU6T74V18Y1W182
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O CORPORATION SERVICE COMPANY, 19808 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 55190032

We are a commercial-stage company with a late-stage pipeline committed to redefining what is possible in bringing life-changing therapies to people living with rare diseases. We are focused on expanding patient access, progressing our pipeline toward key milestones, and delivering meaningful therapeutics. Our vision is realized through disciplined execution of our strategic plan and our core values — patient centricity, integrity, accountability, innovation, and courage — which guide our efforts to deliver long-term value. The commercialization of our lead product, marketed in the United States for Niemann-Pick disease type C (NPC), a rare, progressive neurodegenerative disease, provides a strong corporate foundation and demonstrates our ability to advance therapies from development to market.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

-59.1%Operating margin6
78.2%Net margin6
350.9%Revenue growth, 20256
53.8%Return on equity6
0.40×Debt to equity6
-$2.4MFree cash flow6

What sells

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

Products and services

Miplyffa brought in 99% of the revenue ZEVRA THERAPEUTICS, INC. broke down this way in fiscal 2025.

  1. Miplyffa$87.4M699%up 765% from 2024
  2. Olpruva$800.0K61%up 700% from 2024
Products and services by year
Products and services20242025
Miplyffa$10.1M$87.4M
Olpruva$100.0K$800.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Selling, general and admin47¢$77.6M
  • Income tax2¢$3.4M
  • Profit51¢$83.2M

Out of $106.5M in revenue.6

Financial statements

Revenue78910116$106.5M in 2025+729% since 2019
0$50.0M$100.0M$150.0M2019: $12.8M$12.8M20192020: $13.3M$13.3M2020+3%2021: $28.6M$28.6M2021+116%2022: $10.2M$10.2M2022−65%2023: $27.5M$27.5M2023+170%2024: $23.6M$23.6M2024−14%2025: $106.5M$106.5M2025+351%
Operating income78910116-$62.9M in 2025+209% since 2019
-$100.0M-$75.0M-$50.0M-$25.0M0$25.0M2019: -$20.3M-$20.3M20192020: -$5.6M-$5.6M2020−72%2021: $7.7M$7.7M20212022: -$42.6M-$42.6M20222023: -$49.6M-$49.6M2023+17%2024: -$87.0M-$87.0M2024+75%2025: -$62.9M-$62.9M2025−28%
Net income78910116$83.2M in 2025
-$150.0M-$100.0M-$50.0M0$50.0M$100.0M2019: -$24.5M-$24.5M20192020: -$12.8M-$12.8M2020−48%2021: -$8.6M-$8.6M2021−33%2022: -$26.8M-$26.8M2022+213%2023: -$46.0M-$46.0M2023+72%2024: -$105.5M-$105.5M2024+129%2025: $83.2M$83.2M2025

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Revenue, net$106.5M$23.6M
Cost of product revenue (excluding $X and $X in intangible asset amortization for the years ended XXX XX, 20XX, and 20XX, respectively, shown separately below)$16.5M$7.4M
Impairment of intangible assets$58.7M$0
Research and development$12.7M$42.1M
Selling, general and administrative$77.6M$54.9M
Total operating expenses$90.4M$97.0M
Loss from operations-$62.9M-$87.0M
Gain on sale of PRV$148.3M$0
Interest expense-$8.0M-$7.4M
Fair value adjustment related to warrant and CVR liability$2.2M$2.1M
Fair value adjustment related to investments$149.0K-$18.0K
Interest and other income, net$6.9M$2.2M
Total other income (expense)$149.6M-$3.1M
Income (loss) before income taxes$86.7M-$90.1M
Income tax expense-$3.4M-$15.4M
Net income (loss)$83.2M-$105.5M
Basic (in dollars per share)$1.40-$2.28
Diluted (in dollars per share)$1.35-$2.28
Basic (in shares)55.3M shares46.3M shares
Diluted (in shares)57.3M shares46.3M shares
Intangible asset amortization$3.9M$6.2M

Compare ZEVRA THERAPEUTICS, INC. with another company

Corporate structure

ZEVRA THERAPEUTICS, INC. sits at the top of its group. 3 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of ZEVRA THERAPEUTICS, INC.

  • Woodline Partners LP Filed SCHEDULE 13G/A on ZEVRA THERAPEUTICS, INC., latest Aug 14, 2026 (3 filings since Nov 14, 2024)
  • FMR LLC Filed SCHEDULE 13G/A on ZEVRA THERAPEUTICS, INC., latest Aug 6, 2026 (2 filings since May 6, 2026)
  • VANGUARD CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on ZEVRA THERAPEUTICS, INC., latest Jul 31, 2026
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on ZEVRA THERAPEUTICS, INC., latest Mar 27, 2026 (3 filings since Nov 4, 2024)
  • Adage Capital Management, L.P. Filed SCHEDULE 13G/A on ZEVRA THERAPEUTICS, INC., latest Nov 13, 2025 (2 filings since Feb 12, 2025)
  • Nantahala Capital Management, LLC Filed SCHEDULE 13G/A on ZEVRA THERAPEUTICS, INC., latest Feb 14, 2025 (3 filings since Feb 14, 2024)
  • BlackRock Filed SCHEDULE 13G/A on ZEVRA THERAPEUTICS, INC., latest Feb 5, 2025 (4 filings since Feb 4, 2022)
  • Samuel J. Braun Filed SC 13G/A on ZEVRA THERAPEUTICS, INC., latest Jan 12, 2022 (2 filings since Dec 1, 2021)
  • Empery Asset Management, LP Filed SC 13G/A on ZEVRA THERAPEUTICS, INC., latest Jan 11, 2022
  • ZEVRA THERAPEUTICS, INC. Celebration, Florida, United States
    • Acer Therapeutics Inc. Subsidiary · Delaware, United States
    • Zevra Denmark A/S Subsidiary · Denmark

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What ZEVRA 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, before depreciation$2.1M11 Dec 31, 2024$2.4M11 Dec 31, 2023−12.2%
Accumulated depreciation$1.7M11 Dec 31, 2024$1.6M11 Dec 31, 2023+5.6%
Property and equipment, net$489.0K6 Dec 31, 2025$356.0K6 Dec 31, 2024+37.4%
Finance-lease assets$8.0K11 Dec 31, 2024$149.0K11 Dec 31, 2023−94.6%
Operating-lease assets (leased space)$1.2M6 Dec 31, 2025$657.0K6 Dec 31, 2024+84.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$62.4M6 Dec 31, 2025$33.8M6 Dec 31, 2024+84.7%
Marketable securities, current$128.6M6 Dec 31, 2025$35.7M6 Dec 31, 2024+260.1%
Marketable securities, non-current$47.9M6 Dec 31, 2025$6.0M6 Dec 31, 2024+696.7%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$4.7M6 Dec 31, 2025$4.7M6 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$6.4M6 Dec 31, 2025$69.0M6 Dec 31, 2024−90.7%
Indefinite-lived intangibles (excluding goodwill)$2.0M11 Dec 31, 2024$2.0M11 Dec 31, 20230%
Finite-lived intangibles, net$61.3M11 Dec 31, 2024$67.2M11 Dec 31, 2023−8.8%

Inventory

ItemLatestA year beforeChange
Inventory, total$1.7M6 Dec 31, 2025$2.0M6 Dec 31, 2024−11.7%
Raw materials$7.0K6 Dec 31, 2025$7.9M6 Dec 31, 2024−99.9%
Work in process$1.8M6 Dec 31, 2025$3.3M6 Dec 31, 2024−45.4%
Finished goods$832.0K6 Dec 31, 2025$1.8M6 Dec 31, 2024−53.3%

Properties, in its own words

In 2026, we changed the location of our headquarters from Celebration, Florida to Boston, Massachusetts where we sublease approximately 10,000 square feet of office space under a lease that expires in June 2028. We continue to lease approximately 6,000 square feet of office space in Celebration, Florida under a non-cancelable lease agreement that expires in August 2026, as well as office space in Copenhagen, Denmark. As we continue to grow our headquarters in Boston, we expect that we will require additional space, and we are currently negotiating with the landlord to lease additional office space.

Item 2 of the 10-K filed Mar 9, 2026.5

Leadership

Who has led ZEVRA THERAPEUTICS, INC., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (25)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • KEMPHARM, INCMay 30, 2013 to Feb 24, 20233
  • KEMPHARM INCMay 6, 2008 to Jun 30, 20113

Timeline

  1. Aug 5, 20268-K Results of operations44
  2. Jun 5, 20268-K Shareholder vote45
  3. May 6, 20268-K Results of operations46
  4. Mar 16, 20268-K Entered a material agreement; Ended a material agreement; Regulation FD disclosure47
  5. Mar 9, 20268-K Results of operations; Executive or director change48
  6. Dec 17, 20258-K Executive or director change49
  7. Dec 2, 20258-K Executive or director change; Regulation FD disclosure50
  8. Nov 20, 20258-K Executive or director change; Regulation FD disclosure51
  9. Nov 5, 20258-K Results of operations52
  10. Aug 12, 20258-K Results of operations53
  11. May 29, 20258-K Shareholder vote54
  12. May 13, 20258-K Results of operations55
  13. Oct 10, 2023New chief executive Neil F. McFarlane becomes CEO15
  14. Jan 11, 2023New chief executive Richard W. Pascoe becomes CEO14
  15. Apr 15, 2015New chief executive Travis C. Mickle becomes CEO16
  16. May 28, 2014Founded ZEVRA THERAPEUTICS, INC. is founded2

Calendar

Coming up

  1. Nov 3, 2026 · After the closeReports results for the quarter ending Sep/2026 A year earlier it reported ($0.01) a share, on Nov 5, 2025.56

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results44
  2. May 6, 2026Reported quarterly or annual results46
  3. Mar 9, 2026Reported quarterly or annual results48
  4. Nov 5, 2025Reported quarterly or annual results52
  5. Aug 12, 2025Reported quarterly or annual results53
  6. May 13, 2025Reported quarterly or annual results55
  7. Apr 7, 2025Reported quarterly or annual results57
  8. Mar 11, 2025Reported quarterly or annual results58

Drug trials and FDA: recently

  1. Feb 28, 2024Phase 2 trial completed Phase 2 trial of Serdexmethylphenidate in Idiopathic Hypersomnia: primary completion Feb 28, 2024, results posted Jun 30, 2026 (ClinicalTrials.gov NCT05668754).59

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

363 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 75 major events, 140 insider forms, 21 large holders, 107 other. The latest 20:

  1. Oct 13, 2026144 EDGAR
  2. Oct 13, 20264 EDGAR
  3. Aug 17, 20264 EDGAR
  4. Aug 14, 2026144 EDGAR
  5. Aug 14, 2026SCHEDULE 13G/A EDGAR
  6. Aug 12, 20264 EDGAR
  7. Aug 6, 2026SCHEDULE 13G/A EDGAR
  8. Aug 5, 202610-Q EDGAR
  9. Aug 5, 20268-K EDGAR
  10. Jul 31, 2026SCHEDULE 13G EDGAR
  11. Jul 8, 2026144 EDGAR
  12. Jun 23, 20264 EDGAR
  13. Jun 18, 20264 EDGAR
  14. Jun 18, 20264 EDGAR
  15. Jun 18, 20264 EDGAR
  16. Jun 18, 20264 EDGAR
  17. Jun 18, 20264 EDGAR
  18. Jun 18, 20264 EDGAR
  19. Jun 5, 20268-K EDGAR
  20. May 29, 20264 EDGAR

The 363 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

58 open-market trades by officers, directors and large owners since October 2021: 39 buys and 19 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 14, 2026Thompson RahsaanChief Legal & ComplianceSale42,666$11.13$474.9KForm 4
Aug 10, 2026Watton Corey MichaelDirectorSale12,300$11.25$138.4KForm 4
Jun 22, 2026Thompson RahsaanChief Legal & ComplianceSale34,557$12.68$438.2KForm 4
May 11, 2026Thompson RahsaanChief Legal & ComplianceSale1,794$11.30$20.3KForm 4
Feb 9, 2026McFarlane Neil F.President and CEOSale14,625$8.56$125.2KForm 4
Feb 3, 2026Schafer JoshuaCCOSale10,500$9.19$96.5KForm 4
Feb 3, 2026Sangiovanni Timothy J.SVP, Finance & Corp ControllerSale3,000$9.18$27.5KForm 4
Feb 2, 2026McFarlane Neil F.President and CEOSale91,000$9.38$853.6KForm 4
Jan 30, 2026Schafer JoshuaCCOSale3,375$8.83$29.8KForm 4
Jan 30, 2026Quartel Adrian WChief Medical OfficerSale4,533$8.83$40.0KForm 4
Jan 30, 2026Thompson RahsaanChief Legal & ComplianceSale4,080$8.83$36.0KForm 4
Jan 30, 2026Sangiovanni Timothy J.SVP, Finance & Corp ControllerSale1,750$8.82$15.4KForm 4
Oct 10, 2025McFarlane Neil F.President and CEOSale19,500$10.82$211.0KForm 4
Sep 12, 2025Shih AlvinDirectorBuy20,000$7.89$157.8KForm 4
Sep 12, 2025FAVORITO TAMARA ADirectorBuy3,175$7.79$24.7KForm 4
Aug 19, 2025Bode John BDirectorBuy5,000$9.17$45.9KForm 4
Jun 26, 2025Thompson RahsaanChief Legal & ComplianceSale24,000$9.21$221.0KForm 4
Mar 28, 2025Watton Corey MichaelDirectorBuy300$7.84$2.4KForm 4
Mar 19, 2025Bode John BDirectorBuy10,000$7.96$79.6KForm 4
Feb 14, 2025McFarlane Neil F.President and CEOSale30,544$8.05$245.9KForm 4

All 58 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
2025R. LaDuane CliftonMBA, CPA Former Chief Financial Officer and Treasurer$477.3K$3.8M69
2025Neil F. McFarlanePresident, Chief Executive Officer and Director$729.2K$3.8M69
2025Rahsaan W. ThompsonChief Legal Officer, Secretary and Compliance Officer$466.7K$1.6M69
2024Neil F. McFarlanePresident, Chief Executive Officer and Director$700.0K$5.4M69
2024R. LaDuane CliftonMBA, CPA Former Chief Financial Officer and Treasurer$460.9K$1.5M69

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.5,108,871$73.3M0.0%+652,395
Fmr LLC4,915,717$70.5M0.0%+1,703,840
Woodline Partners LP4,785,771$68.6M0.2%+1,334,828
Nantahala Capital Management, LLC3,594,952$51.6M1.6%+1,073,016
Vanguard Capital Management LLC2,638,910$37.8M0.0%+169,582
State Street Corp1,681,999$24.1M0.0%+120,430
Geode Capital Management, LLC1,540,936$22.1M0.0%+169,079
D. E. Shaw & Co., Inc.1,306,949$18.7M0.0%+460,492
Qube Research & Technologies Ltd1,241,343$17.8M0.0%+399,024
Morgan Stanley1,203,875$17.3M0.0%+11,613
Legal & General Group Plc1,201,668$17.2M0.0%+38,578
Dimensional Fund Advisors LP958,836$13.7M0.0%+404,034
Royce & Associates LP882,658$12.7M0.1%−106,016
683 Capital Management, LLC855,000$12.3M1.2%−120,000
Kingdon Capital Management, L.l.c.775,000$11.1M1.5%No change
Retirement Planning Co of New England, Inc.634,410$9.1M3.3%−16,738
Jupiter Topco LLC613,403$8.8M0.0%New
Arrowstreet Capital, Limited Partnership597,162$8.6M0.0%New
Goldman Sachs Group Inc545,551$7.8M0.0%−197,573
Vanguard Portfolio Management LLC541,109$7.8M0.0%+74,806
Northern Trust Corp486,498$7.0M0.0%+49,548
Swedbank AB439,410$6.3M0.0%New
Schroder Investment Management Group439,328$6.2M0.0%−66,705
Tudor Investment Corp Et Al415,058$6.0M0.0%−28,051
Stratos Wealth Partners, LTD.408,000$5.9M0.1%No change

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

SEC filer profile

How ZEVRA 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 EDGARZEVRA THERAPEUTICS, INC.1
  • CIK0001434647
  • Employer ID (EIN)20-58943985
  • Filer statusNon-accelerated filer not an emerging growth company; 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 address101 Federal Street, Boston, MA 021101
  • Phone(888) 958-12531
  • Shares outstanding59,383,781 as of Jul 31, 202613
  • Public float$454.8M as of Jun 30, 20255
  • AuditorErnst & Young LLP, Orlando, Florida PCAOB ID 42; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceMay 6, 20081
  • Filings867 in all: 4 (284), 8-K (203), 10-Q (35), DEFA14A (34), 3 (30), SC 13G/A (29), 424B3 (24), CORRESP (20)1
    All 54 form types

    424B5 (18), 144 (17), UPLOAD (17), S-8 (14), SC 13G (14), EFFECT (12), 10-K (11), D (10), DEF 14A (10), S-3 (8), SCHEDULE 13G/A (8), 8-K/A (5), S-1/A (5), DEFC14A (4), CT ORDER (3), PREC14A (3), PRRN14A (3), S-1 (3), SCHEDULE 13G (3), 424B4 (2), 425 (2), 8-A12B (2), D/A (2), DFAN14A (2), DRS/A (2), DRSLTR (2), POS AM (2), POS EX (2), PRE 14A (2), PRER14A (2), S-3/A (2), SEC STAFF LETTER (2), 10-K/A (1), 25-NSE (1), 424B2 (1), CERT (1), CERTNAS (1), DRS (1), NT 10-Q (1), PREN14A (1), REGDEX (1), RW (1), S-1MEF (1), S-4 (1), S-4/A (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Mar 9, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 20, 2026
    Latest 8-K (8-K) Aug 5, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par valueZVRANasdaq

From the cover page of the 10-K filed Mar 9, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks ZEVRA THERAPEUTICS, INC. names in Item 1A of its 10-K filed Mar 9, 2026: 45 risks under these headings, as written.5

  • Risks Related to the Commercialization of Our Approved Products and Product Candidates
  • If we are unable to establish effective sales, marketing and distribution capabilities for our approved products, including any of our product candidates that may receive marketing approval, we may not be successful in commercializing such products in the United States or any other jurisdictions.
  • Our approved products, as well as any of our product candidates that may receive marketing approval, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  • Failure to obtain or maintain coverage and adequate reimbursement for our products could limit our ability to market those products and decrease our ability to generate revenue.
  • Because the target patient population for our products and product candidates is small, we must achieve significant market share and obtain relatively high per-patient prices for our products to achieve meaningful gross margins.
  • We face substantial competition, which may result in others developing or commercializing products before or more successfully than we do.
  • We may be subject to enforcement action if we engage in improper marketing or promotion of our products.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our approved products, or any of our product candidates that we may develop.
  • Significant political, trade, regulatory developments, and other circumstances beyond our control could delay, prevent or impair our development or commercialization efforts.
  • Our product candidates may be associated with serious adverse events, undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
  • Any side effects or adverse events caused by approved products following regulatory approval, could result in a number of potentially significant negative consequences.
  • A variety of risks associated with marketing our approved products and any of our product candidates, if approved, internationally, could affect our business.
The other 34 risks
  • If our Global EAP program is terminated prior to regulatory approval and commercialization of arimoclomol in applicable foreign jurisdictions, it will have a material adverse effect on our business, results of operations, cash flows, financial condition and/or prospects.
  • Risks Related to Our Business and Our Financial Position
  • We are highly dependent on one product for substantially all of our revenues, and any loss of revenue from this product could materially harm our business.
  • We have had recurring negative net operating cash flows throughout our operating history, and we cannot guarantee or predict when we may begin to consistently generate positive net cash flows from operations, or if at all.
  • We might not be able to utilize a significant portion of our net operating loss carryforwards, which could adversely affect our profitability.
  • We recognized an impairment charge related to intangible assets. If our remaining assets become impaired in the future, we would incur additional impairment charges, which would negatively affect our operating results.
  • Risks Related to Our Dependence on Third Parties
  • We rely on a limited number of suppliers, in some cases sole-source suppliers.
  • The facilities used by our third-party contract manufacturers to manufacture our approved products and any of our product candidates are subject to review by the FDA pursuant to inspections, and such inspections could result in findings that lead to failure to obtain FDA approval of such marketing applications.
  • We rely on a limited number of third‑party distribution partners to commercialize MIPLYFFA, and the loss or inadequate performance of any of these partners could materially and adversely affect our ability to supply MIPLYFFA in key territories.
  • We rely on and expect to continue to rely on third parties to conduct our clinical trials for our product candidates, and those third parties may not perform satisfactorily.
  • We have entered into a collaboration with Commave, to develop, manufacture and commercialize AZSTARYS worldwide. If this collaboration is not successful, we may not be able to capitalize on the market potential of AZSTARYS.
  • We may seek to establish collaborations for certain product candidates, which may not be available on acceptable terms, or at all.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain intellectual property protection for our technology, our approved products or our product candidates, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology, our approved products, or our product candidates if approved, may be impaired.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
  • Third parties may initiate legal proceedings against us alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could significantly harm our business.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
  • If we are not able to obtain required regulatory approvals for any of our product candidates, we will not be able to commercialize them and our ability to generate revenue or profits could be limited.
  • If we experience delays or difficulties in the enrollment of subjects in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
  • Interim, topline, or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Our approved products are, and any of our product candidates for which we obtain marketing approval will be, subject to significant post-marketing regulatory requirements and oversight.
  • Our approved products are, and if marketing approval of any of our product candidates is granted, such product candidates may be, subject to limitations on the indicated uses for which the product may be marketed.
  • Current and future healthcare reform legislation or regulation may increase the difficulty and cost for us to obtain marketing approval of our product candidates and increase the cost to commercialize our approved products.
  • We may not be able to obtain or maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
  • Our current and future relationships with healthcare professionals, principal investigators, consultants, customers and third-party payors in the United States and elsewhere may be subject to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency, and other healthcare laws and regulations, which could expose us to penalties.
  • If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in which we participate, we could be subject to additional reimbursement requirements, penalties, sanctions and fines.
  • Risks Related to Cybersecurity and Data Privacy
  • Cybersecurity breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
  • We are currently subject to, and may in the future become subject to additional, U.S. federal and state and international laws and regulations imposing obligations on how we collect, store and process personal information.
  • Risks Related to Ownership of Our Common Stock
  • The trading price of the shares of our common stock is likely to be volatile, and purchasers of our common stock could incur substantial losses.
  • Anti-takeover provisions in our amended and restated certificate of incorporation and amended and restated bylaws, as well as provisions of Delaware law and the terms of some or our contracts, might discourage, delay or prevent a change in control of our company or changes in our board of directors or management and, therefore, depress the price of our common stock.
  • We could be negatively affected as a result of the actions of activist stockholders, which could be disruptive and costly and may conflict with or disrupt the strategic direction of our business.
  • Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains and you may never receive a return on your investment.

Legal proceedings

From time to time, we may be involved in routine legal proceedings, as well as demands, claims and threatened litigation, which arise in the normal course of our business.

In connection with the AZSTARYS License Agreement with Commave, a dispute has arisen with Commave concerning the interpretation of certain provisions under the AZSTARYS License Agreement. On September 4, 2024, Commave filed a complaint against us in the Court of Chancery of the State of Delaware (Case No. 2024-0920-LWW) alleging breach of contract and seeking injunctive relief, specific performance, declaratory relief, and damages regarding the parties' respective rights and obligations under the Agreement. On February 12, 2025, our motion to dismiss was denied and the case is now in the discovery phase. On July 17, 2025, Zevra and Commave filed cross motions for partial summary judgment as to certain of Commave’s claims, and the court held oral argument on the parties' cross motions on September 22, 2025. On December 31, 2025, the court granted Commave’s motion for partial summary judgment and denied our motion for partial summary judgment. Trial is currently scheduled to commence on June 8, 2026. We strongly disagree with Commave's allegations and believe this lawsuit is without merit.

The litigation is in its early stages. While we intend to vigorously defend against Commave's claims, the outcome of this matter is inherently uncertain. We cannot predict with certainty the timing or ultimate outcome of this litigation or its potential impact on our business, financial condition, or results of operations. At this time, we have not recorded any accrual for contingent liability associated with this matter. We will continue to monitor developments in this matter and will assess the potential impact on our financial statements in future periods. We expect to incur significant legal expenses in connection with this litigation, which may materially affect our results of operations in future periods.

The opening of Item 3, Legal Proceedings.5

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