---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-26-060830"
form_type: "8-K"
ticker: null
cik: "0002108121"
company_name: "Ionetix Corp / DE /"
filed_at: "2026-05-26T14:00:15+00:00"
generated_at: "2026-05-26T14:01:20.014674+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Ionetix receives FDA approval for Gallium Ga-68 gozetotide (PSMA-11) ANDA

## Summary
- FDA approved Ionetix's Abbreviated New Drug Application for Gallium Ga-68 gozetotide, a PET diagnostic agent.
- First commercial drug manufacturer to receive ANDA approval for this drug.
- Indicated for PSMA-PET imaging to detect prostate cancer lesions in men with suspected metastasis or recurrence.
- Product supplied as single-dose capped syringe (~8-10mL) with three-hour expiration from end of synthesis.
- Expands Ionetix's portfolio in PET diagnostics; company plans to serve underserved areas via existing multi-site PET facility network.

## SEC filing metadata
- accession: 0001213900-26-060830
- form_type: 8-K
- cik: 0002108121
- company_name: Ionetix Corp / DE /
- filed_at: 2026-05-26T14:00:15+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/2108121/000121390026060830/0001213900-26-060830-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/2108121/000121390026060830/ea0292072-8k_ionetix.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-26-060830
- JSON: https://secwatch.observer/filing/0001213900-26-060830.json
- Plain text: https://secwatch.observer/filing/0001213900-26-060830.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.