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Plus Therapeutics Gains FDA Orphan Status for REYOBIQ

Story Highlights
  • Plus Therapeutics received U.S. FDA Orphan Drug Designation for REYOBIQ on April 8, 2026, covering pediatric malignant gliomas and ependymoma.
  • The orphan status strengthens REYOBIQ’s strategic value by adding regulatory incentives and supporting its expansion across multiple CNS cancer indications.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Plus Therapeutics Gains FDA Orphan Status for REYOBIQ

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The latest announcement is out from Plus Therapeutics ( (PSTV) ).

On April 8, 2026, Plus Therapeutics announced that the U.S. Food and Drug Administration granted Orphan Drug Designation to its lead radiotherapeutic candidate REYOBIQ for the treatment of pediatric malignant gliomas, with the designation applying more broadly than requested to include pediatric ependymoma. Pediatric malignant gliomas and related high-grade gliomas are rare, aggressive brain tumors with limited treatment options and poor prognosis, and the orphan status confers potential benefits such as market exclusivity, tax credits and fee reductions, reinforcing REYOBIQ’s strategic value and supporting the company’s broader regulatory and clinical progress across multiple central nervous system cancer indications.

The most recent analyst rating on (PSTV) stock is a Buy with a $12.00 price target. To see the full list of analyst forecasts on Plus Therapeutics stock, see the PSTV Stock Forecast page.

Spark’s Take on PSTV Stock

According to Spark, TipRanks’ AI Analyst, PSTV is a Underperform.

The score is driven primarily by very weak financial performance (zero 2025 revenue, widening losses, and accelerating cash burn), reinforced by bearish technicals with the stock far below key moving averages. Positive corporate updates and governance additions help at the margin, but do not outweigh the current funding and profitability risks; valuation signals are limited by negative earnings.

To see Spark’s full report on PSTV stock, click here.

More about Plus Therapeutics

Plus Therapeutics, Inc., headquartered in Houston, Texas, is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for difficult-to-treat central nervous system cancers. Its lead product candidate, REYOBIQ (rhenium Re186 obisbemeda), is being advanced through clinical trials in indications such as leptomeningeal metastases, recurrent glioblastoma and pediatric brain cancers, supported by grants and a specialized CNS diagnostics subsidiary.

The company combines image-guided local beta radiation with targeted drug delivery to concentrate high-dose radiotherapy at tumor sites while limiting damage to healthy tissue. It has built a supply chain through strategic partnerships to support development, manufacturing and potential commercialization of its CNS oncology pipeline.

Average Trading Volume: 463,832

Technical Sentiment Signal: Sell

Current Market Cap: $20.04M

For detailed information about PSTV stock, go to TipRanks’ Stock Analysis page.

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