Heron Therapeutics Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits
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Item 7.01 Regulation FD Disclosure.
On July 2, 2024, Heron Therapeutics, Inc. issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has acknowledged the receipt of the Company’s Prior Approval Supplement application for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution Vial Access Needle, as further described in the press release. The FDA has assigned a Prescription Drug User Fee Act goal date of September 23, 2024. A copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated by reference in this Item 7.01.
As provided in General Instruction B.2 of Form 8-K, the information in this Item 7.01, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall such information or Exhibit 99.1 be deemed to be incorporated by reference in any filing under the Securities Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
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99.1 |
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104 |
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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.
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Heron Therapeutics, Inc. |
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Date: July 2, 2024 |
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/s/ Ira Duarte |
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Ira Duarte |
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Executive Vice President, Chief Financial Officer |