# EDGAR Filing Document

**Accession Number:** 0002108121
**File Stem:** 0001213900-26-060830
**Filing Date:** 2026-5
**Character Count:** 9438
**Document Hash:** f53b71f054fbb8f10d5b59fe2850133a
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-26-060830.hdr.sgml**: 20260526

**ACCESSION NUMBER**: 0001213900-26-060830

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20260526

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260526

**DATE AS OF CHANGE**: 20260526

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Ionetix Corp / DE /
- **CENTRAL INDEX KEY:** 0002108121
- **STANDARD INDUSTRIAL CLASSIFICATION:** BLANK CHECKS [6770]
- **ORGANIZATION NAME:** 05 Real Estate & Construction
- **EIN:** 422828779
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 000-56821
- **FILM NUMBER:** 261016492

**BUSINESS ADDRESS:**
- **STREET 1:** THE GALLERIA, 2 BRIDGE AVENUE
- **STREET 2:** SUITE 241
- **CITY:** RED BANK
- **STATE:** NJ
- **ZIP:** 07701
- **BUSINESS PHONE:** 732-241-3073

**MAIL ADDRESS:**
- **STREET 1:** THE GALLERIA, 2 BRIDGE AVENUE
- **STREET 2:** SUITE 241
- **CITY:** RED BANK
- **STATE:** NJ
- **ZIP:** 07701

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** JDEV Acquisition Corp
- **DATE OF NAME CHANGE:** 20260128

?xml version='1.0' encoding='ASCII'?

**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 26, 2026**

![](ea029207201_img1.jpg)

**IONETIX CORPORATION**

(Exact Name of Registrant as Specified in Charter)

---

| | | |
|:---|:---|:---|
| **Delaware** | **000-56821** | **41-2828779** |
| (State or Other Jurisdiction<br> of Incorporation) | (Commission File Number) | (IRS Employer<br> Identification No.) |

---

---

| | |
|:---|:---|
| **3130 Sovereign Drive**<br> **Lansing, MI** | **48911** |
| (Address of Principal Executive Offices) | (Zip Code) |

---

**(517) 252-4069** (Registrant's telephone number, including area code)

**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:

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

◻ Soliciting material pursuant to Rule l4a-12 under the Exchange Act (17 CFR 240.l4a-l2)

◻ Pre-commencement communications pursuant to Rule l4d-2(b) under the Exchange Act (17 CFR 240.l4d-2(b))

◻ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.l3e-4(c))

**Securities registered pursuant to Section 12(b) of the Act: None.**

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 – 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*

---

| | |
|:---|:---|
| <br> **Exhibit No.** | **Description** |
| 99.1 | [Press release of Ionetix Corporation dated May 26, 2026](ea029207201ex99-1.htm) |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL) |

---

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 | IONETIX CORPORATION |
| Dated: | 05/26/2026 | By: | /s/ Kevin Cameron |
|  |  |  | Kevin Cameron, Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**Ionetix Announces Approval of Abbreviated New Drug Application for Gallium Ga-68 Gozetotide (PSMA-11)**

*Leading particle accelerator company expands portfolio of positron emission tomography diagnostics* 

 

LANSING, Mich., May 26, 2026 (GLOBE NEWSWIRE) -- Ionetix Corporation ("Ionetix"), a leading particle accelerator company focused on the medical, materials testing and nuclear energy space, announced today that the Federal Drug Administration (FDA) has approved its Abbreviated New Drug Application for Gallium Ga-68 gozetotide. Ionetix is the first commercial drug manufacturer to receive ANDA approval for the drug.

"Ionetix is excited to have the opportunity to offer gallium Ga-68 gozetotide to enable PSMA-PET imaging of men with prostate cancer," said Jill Wilson, Vice President of Regulatory Affairs and Quality Assurance. "This approval will allow Ionetix to provide doses to underserved areas from our existing multi-site network of PET facilities."

Gallium Ga-68 gozetotide injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) scanning of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. The product is supplied in a single-dose capped syringe in approximately 8 to 10mL and has a three-hour expiration from end of synthesis.

Ionetix's patent-protected superconducting cyclotron technology supports unique particle accelerator solutions with applicability across the medical and industrial applications. Ionetix is currently generating revenue in the medical isotopes space, in both PET diagnostics and alpha emitter therapeutics.

**About Ionetix**

Ionetix is a leader in cyclotron technology and radioisotope manufacturing, providing innovative solutions that enable access to scarce isotopes for diagnostic and therapeutic radiopharmaceuticals. Ionetix supplies high-purity Actinium-225 (Ac-225) and Astatine-211 (At-211) for use in targeted alpha therapies, supported by a comprehensive distribution network, contract drug manufacturing services, and specialized "white glove" logistics to ensure global access.

**Safe Harbor for Forward-Looking and Cautionary Statements**

This press release 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 of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements relate to, among others, our plans, objectives and expectations for our business, operations and financial performance and condition. Forward-looking statements can include terminology such as "may," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "will," "could," "project," "target," "potential," "continue" and similar expressions that do not relate solely to historical matters or actual results.

IR@ionetix.com; +1-517-252-4069

For media inquiries, please contact: PR@ionetix.com

Source: Ionetix Corporation