{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-146335","form_type":"8-K","ticker":"PSTV","cik":"0001095981","company_name":"PLUS THERAPEUTICS, INC.","filed_at":"2026-04-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:31.945005+00:00","generated_at":"2026-05-15T06:52:15.570941+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"confidence":"high","headline":"Plus Therapeutics' REYOBIQ gets FDA Orphan Drug Designation for pediatric malignant gliomas","bullets":["ODD covers pediatric malignant gliomas including ependymoma, broader than originally requested.","Designation provides 7 years of market exclusivity upon approval, tax credits, and fee exemptions.","Follows FDA Type B meeting supporting development in leptomeningeal metastases and IND clearance for pediatric high-grade glioma and ependymoma.","REYOBIQ delivers targeted radiotherapy to CNS tumors while minimizing healthy brain exposure."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-146335","json":"https://secwatch.observer/filing/0001193125-26-146335.json","markdown":"https://secwatch.observer/filing/0001193125-26-146335.md","text":"https://secwatch.observer/filing/0001193125-26-146335.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1095981/000119312526146335/0001193125-26-146335-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1095981/000119312526146335/pstv-20260408.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T06:52:15.570941+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"}