[8-K] Xeris Biopharma Holdings, Inc. Reports Material Event

☐000186709600018670962026-02-262026-02-26

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 26, 2026

XERIS BIOPHARMA HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-40880

87-1082097

(State or other jurisdiction of incorporation)

(Commission File Number)

(I.R.S. Employer Identification No.)

1375 West Fulton Street, Suite 1300

Chicago, Illinois 60607

(Address of principal executive offices, including zip code)

(844) 445-5704

(Registrant's telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

XERS

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Other Events.

On February 26, 2026, Xeris Biopharma Holdings, Inc. (the “Company”) issued a press release announcing that its subsidiaries, Xeris Pharmaceuticals, Inc. and Strongbridge Dublin Limited, have filed a patent infringement lawsuit under the Hatch-Waxman Act against two pharmaceutical companies (each, an "ANDA Filer") in the United States District Court for the District of New Jersey regarding each ANDA Filer's submission of an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration seeking approval to engage in the commercial manufacture, use, or sale of a generic version of RECORLEV® (levoketoconazole). A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 7.01 by reference.

The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section and shall not be deemed incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01    Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number						Description
99.1						Press release, dated February 26, 2026, issued by the Company
104						Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: February 26, 2026

Xeris Biopharma Holdings, Inc.

By:

/s/ Steven M. Pieper

Name: Steven M. Pieper

Title: Chief Financial Officer

XERIS BIOPHARMA SUBSIDIARIES FILE RECORLEV® PATENT INFRINGEMENT LAWSUIT

Four Orange Book Listed Patents through March 2040

Orphan Drug Exclusivity through December 2028

CHICAGO, IL; February 26, 2026 – Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, announced that its subsidiaries, Xeris Pharmaceuticals, Inc. and Strongbridge Dublin Limited, have filed a patent infringement lawsuit under the Hatch-Waxman Act related to Recorlev® (levoketoconazole) in the United States District Court for the District of New Jersey against Torrent Pharmaceuticals Limited (along with its affiliate) and Somerset Therapeutics, LLC (along with its affiliates), each of which filed an Abbreviated New Drug Application ("ANDA") with the U.S. Food and Drug Administration (the “FDA”) seeking approval to manufacture, use or sell a generic version of Recorlev® (levoketoconazole) (each, an “ANDA Filer”). Xeris’s complaint seeks an injunction to prevent the manufacture, use, and sale of a generic version of RECORLEV by each ANDA Filer until the expiration of Xeris’s patents in March 2040.

“We are confident in the quality and strength of the intellectual property we have developed for Recorlev,” said John P. Shannon, CEO of Xeris Biopharma. “We have filed this patent infringement lawsuit to vigorously defend our position.”

The complaint was filed following receipt of Paragraph IV Certification Notice Letters from the ANDA Filers (each a “Notice Letter”). In its respective Notice Letter, each ANDA Filer alleged that the four patents covering Recorlev that are listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book), scheduled to expire in March 2040 (U.S. Patent Numbers 11,020,393, 11,278,547, 11,903,940, and 12,377,096), are invalid, unenforceable, or will not be infringed by the respective ANDA Filer's commercial manufacture, use, or sale of the generic levoketoconazole product described in its ANDA submission.

Xeris may receive additional Notice Letters in the future from ANDA filers seeking approval of a generic version of Recorlev and intends to enforce and defend its intellectual property rights relating to Recorlev. Xeris Pharmaceuticals, Inc. and Strongbridge Dublin Limited are represented in this litigation by Latham & Watkins, LLP.

About Xeris

Xeris (Nasdaq: XERS) is a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products: Recorlev®, for the treatment of endogenous Cushing’s syndrome; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia; and Keveyis®, a proven therapy for primary periodic paralysis. Xeris also has a pipeline of development programs led by XP-8121, a Phase 3-ready, once-weekly subcutaneous injection for hypothyroidism, as well as multiple early-stage programs leveraging Xeris’ technology platforms, XeriSol® and XeriJect®, for its partners.  

Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow us on X, LinkedIn, or Instagram.

Forward-Looking Statements

Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans, opportunities, and prospects for the Company, including statements, among other things, regarding its intention to

enforce and defend its intellectual property rights relating to Recorlev®, including any expectations regarding the pending litigation, any plans to file a lawsuit against an ANDA filer in the future and the success or outcome of any such action, and its expectation that the Company will receive additional Notice Letters in the future. Because such statements are subject to risks and uncertainties, they constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on numerous assumptions and assessments made in light of the Company’s experience and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. No assurance can be given that such expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional risks and information about potential impacts of financial, operational, economic, competitive, regulatory, governmental, technological, and other factors that may affect the Company can be found in the Company’s filings, including its most recently filed Annual Report on Form 10-K and subsequent filings with the U.S. Securities and Exchange Commission (“SEC”), the contents of which are not incorporated by reference into, nor do they form part of, this communication. The risks described herein and in the Company’s SEC filings are not the only risks the Company faces. Additional risks and uncertainties not currently known to it or that it currently deems immaterial may also impact its business operations or financial results. Forward-looking statements in this report are based on information available to management, as of the date of this communication and, while the Company believes its assumptions are reasonable, actual results may differ materially. Subject to any obligations under applicable law, the Company does not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations.

Investor Contact
Allison Wey
Senior Vice President, Investor Relations and Corporate Communications
awey@xerispharma.com

Filing Exhibits & Attachments

5 documents

Press Releases

• EX-99.1 EX-99.1 13.0 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT 2.0 KB
• EX-101 XBRL TAXONOMY EXTENSION DEFINITION LINKBASE DOCUMENT 14.6 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE DOCUMENT 25.6 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT 15.2 KB