ヘロンセラピューティクスの適時開示・その他

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): May 6, 2025

Heron Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

     Delaware

     001-33221

     94-2875566

     (State or other jurisdiction
of incorporation)

     (Commission
File Number)

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


100 Regency Forest Drive, Suite 300, Cary, NC		27518
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code (858) 251-4400

N/A

(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 (see General Instruction A.2. below):


☐	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 $0.01 per share	HRTX	The Nasdaq Capital 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 8.01. Other Events.

On May 6, 2025, Heron Therapeutics, Inc. (“Company”) issued a press release announcing its entry into a settlement agreement with Mylan Pharmaceuticals, Inc. (“Mylan”) to resolve the ongoing patent litigations between the parties in the U.S. District Court for the District of Delaware related to CINVANTI® (aprepitant) injectable emulsion and APONVIE® (aprepitant) injectable emulsion. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.



Exhibit No.						Description
99.1						Press Release, dated May 6, 2025
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.


			Heron Therapeutics, Inc.

Date: May 6, 2025			/s/ Ira Duarte
			Ira Duarte Executive Vice President, Chief Financial Officer

EX-99.1 2 hrtx-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

Heron Therapeutics Announces Settlement with Mylan Related to CINVANTI® and APONVIE® Patent Litigations

— Company Grants Mylan a License to Market Generic CINVANTI® and APONVIE® Beginning in June 2032 —

CARY, May 6, 2025 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) (“Heron” or the “Company”), a commercial-stage biotechnology company, today announced that the Company entered into a settlement agreement with Mylan Pharmaceuticals, Inc. (“Mylan”), a Viatris Inc. company, to resolve the ongoing patent litigations between the parties in the U.S. District Court for the District of Delaware related to CINVANTI® (aprepitant) injectable emulsion and APONVIE® (aprepitant) injectable emulsion. Pursuant to the terms of the settlement agreement, the Company has granted Mylan a license under the Orange Book-listed patents for CINVANTI® and APONVIE® (the “Heron Patents”), to market generic versions of CINVANTI® and APONVIE® in the United States beginning June 1, 2032, or earlier under certain customary circumstances.

These patent litigations were initiated by the Company in September 2023 and January 2024 in response to Mylan’s abbreviated new drug applications seeking United States Food and Drug Administration approval of generic versions of CINVANTI® and APONVIE®, respectively, in the United States prior to the expiration of the Heron Patents in 2035. In connection with the settlement, the Company and Mylan will file a proposed Stipulation and Order of Dismissal with the U.S. District Court for the District of Delaware requesting that the Court dismiss the pending litigations between the parties.

About Heron Therapeutics, Inc.

Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com.

Forward-looking Statements

This news release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. Therefore, you should not place undue reliance on forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption “Risk Factors.” Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.

Investor Relations and Media Contact:

Ira Duarte
Executive Vice President, Chief Financial Officer
Heron Therapeutics, Inc.
iduarte@herontx.com
858-251-4400