---
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"
generated_at: "2026-05-15T06:52:15.570941+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Plus Therapeutics' REYOBIQ gets FDA Orphan Drug Designation for pediatric malignant gliomas

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-146335
- JSON: https://secwatch.observer/filing/0001193125-26-146335.json
- Plain text: https://secwatch.observer/filing/0001193125-26-146335.txt

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