{"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","discovered_at":"2026-05-26T14:01:04.394061+00:00","generated_at":"2026-05-26T14:01:20.014674+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"confidence":"high","headline":"Ionetix receives FDA approval for Gallium Ga-68 gozetotide (PSMA-11) ANDA","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-26-060830","json":"https://secwatch.observer/filing/0001213900-26-060830.json","markdown":"https://secwatch.observer/filing/0001213900-26-060830.md","text":"https://secwatch.observer/filing/0001213900-26-060830.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-26T14:01:20.014674+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}