secwatch.observer — SEC 8-K summary
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Issuer:     PLUS THERAPEUTICS, INC. (PSTV)
CIK:        0001095981
Form:       8-K
Filed at:   2026-04-08T23:59:59+00:00
Accession:  0001193125-26-146335
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1095981/000119312526146335/0001193125-26-146335-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1095981/000119312526146335/pstv-20260408.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-146335

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer