Plus Therapeutics Inc. (NASDAQ:PSTV) shares are up on Friday on continuous momentum after the company announced that the U.S. Food and Drug Administration (FDA) on Wednesday granted Orphan Drug Designation for its investigational therapy Reyobiq for pediatric malignant gliomas (brain cancer).
Reyobiq Targets Pediatric Brain Cancer
Plus Therapeutics is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system (CNS).
Reyobiq (rhenium Re186 obisbemeda) is an investigational injectable radiotherapy specifically formulated to deliver direct targeted high-dose radiation in CNS (primarily brain and spine) tumors.
The FDA’s Orphan Drug Designation for Reyobiq, which targets rare and aggressive pediatric brain tumors, provides several potential benefits, including seven years of market exclusivity upon approval.
The designation is particularly significant as it encompasses pediatric ependymoma, expanding the potential impact of the therapy.
Regulatory Progress And Clinical Development Continue
The designation for pediatric malignant gliomas builds on recent regulatory and clinical progress for Reyobiq, including completion of a Type B meeting with the FDA supporting development plans in leptomeningeal metastases (LM), encouraging clinical data from the ReSPECT-LM trial, and ongoing advancement of Phase 1 and Phase 2 studies.
In addition, the company has received FDA clearance of its Investigational New Drug (IND) application to evaluate Reyobiq in pediatric patients with high-grade glioma and ependymoma.
On Tuesday, Plus Therapeutics said that the American Medical Association (AMA) has approved a new, Proprietary Laboratory Analyses Current Procedural Terminology code for its CNSide Cerebrospinal Fluid Tumor Cell Enumeration test.
The dedicated billing code is effective July 1.
Plus Therapeutics Technical Analysis Signals Mixed Trend
At $5.24, the stock is trading right at its 20-day simple moving average (SMA) level, indicating a potential short-term pivot point. However, it remains 17% below its 50-day SMA, suggesting that the intermediate trend is still bearish.
The relative strength index (RSI) is currently at 35.26, indicating neutral momentum, which suggests that the stock is neither overbought nor oversold at this time. The stock has experienced a significant 12-month decline of 73.73%, reflecting a challenging year for investors.
- Key Resistance: $6.00 — This level may act as a barrier for upward movement.
- Key Support: $5.00 — A critical level that could indicate further downside if breached.
PSTV Stock Price Activity: Plus Therapeutics shares were up 33.67% at $5.24 at the time of publication on Friday, according to Benzinga Pro data.
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