UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01 – Regulation FD Disclosure
On May 26, 2026, Ionetix Corporation (the “Company”) issued a press release announcing that the United States Food and Drug Administration has approved the Company’s Abbreviated New Drug Application (ANDA) for Gallium Ga-68 gozetotide (PSMA-11).
A copy of the press release is being furnished with this Current Report on Form 8-K as Exhibit 99.1 and is hereby incorporated herein by reference.
The information in this Item 7.01, including Exhibit 99.1, is being furnished and 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 under that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference.
Safe Harbor for Forward-Looking and Cautionary Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act and Section 21E of the Exchange Act. Forward-looking statements may be identified by terminology such as “may,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “will,” “could,” “project,” “target,” “potential,” “continue,” and similar expressions. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks described in the Company’s filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update any forward-looking statements except as required by law.
Item 9.01 – Financial Statements and Exhibits
(d) Exhibits
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Exhibit No. |
Description | |
| 99.1 | Press release of Ionetix Corporation dated May 26, 2026 | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this current report to be signed on its behalf by the undersigned hereunto duly authorized.
| IONETIX CORPORATION | |||
| Dated: | 05/26/2026 | By: | /s/ Kevin Cameron |
| Kevin Cameron, Chief Executive Officer | |||
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