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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01. Regulation FD Disclosure
On April 27, 2023, Aytu BioPharma, Inc. (the “Company”) issued a press release titled “Aytu BioPharma Announces Approval of Adzenys XR-ODT Manufacturing Site Transfer”
A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K. The information in this Item 7.01 and the exhibit attached hereto shall not be deemed “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, or incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.
Item 8.01. Other Events
On April 27, 2023, the Company announced its receipt of U.S. Food & Drug Administration (the “FDA”) approval of the Adzenys XR-ODT® Prior Approval Supplement (“PAS”). Additionally, the Company’s Cotempla XR-ODT® (“Cotempla”) bioequivalence study has been successfully completed. Accordingly, the Company expects to submit the Cotempla site transfer PAS to the FDA in the middle of calendar 2023.
Forward-Looking Statements; Risks and Uncertainties
This Current Report on Form 8-K contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, but are not limited to, statements related to the submission of Cotempla to the FDA. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties, many of which are beyond the Company’s control, that may cause actual results or events to differ materially from those projected. These risks and uncertainties include risks described in the section entitled “Risk Factors” and elsewhere in the Company’s Annual Report on Form 10-K and in our other filings with the U.S. Securities and Exchange Commission, including, without limitation, our reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit |
| Description |
99.1 | ||
104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document) |
