Plus Therapeutics Receives FDA Orphan Drug Designation
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 08 2026
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Should l Buy PSTV?
Source: Newsfilter
- Orphan Drug Designation: Plus Therapeutics' REYOBIQ™ has received Orphan Drug Designation from the FDA for treating pediatric malignant gliomas, marking a significant milestone that supports the company's innovation in rare cancer treatments.
- Market Exclusivity: This designation grants REYOBIQ seven years of market exclusivity, potentially enhancing the company's competitive position in the pediatric cancer treatment market while providing tax incentives for future clinical trials.
- Accelerated Clinical Progress: The orphan drug designation is based on positive clinical data for REYOBIQ in pediatric high-grade gliomas and ependymomas, indicating the drug's potential to improve patient outcomes, especially where existing treatment options are limited.
- Research Funding Support: The company has also received FDA approval for its Investigational New Drug application for REYOBIQ, further advancing its clinical research in pediatric high-grade gliomas and ependymomas, demonstrating ongoing development potential in CNS tumor treatments.
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Analyst Views on PSTV
Wall Street analysts forecast PSTV stock price to rise
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 6.390
Low
2.00
Averages
8.00
High
19.00
Current: 6.390
Low
2.00
Averages
8.00
High
19.00
About PSTV
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company. The Company is engaged in developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system. Combining image-guided local beta radiation and targeted drug delivery approaches, it is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). Its lead radiotherapeutic candidate, REYOBIQ (rhenium (186Re) obisbemeda), is designed specifically for CNS cancers including GBM, LM, and pediatric brain cancers (PBC) by direct localized delivery utilizing approved standard-of-care tissue access such as with convection-enhanced delivery (CED) and intraventricular brain (Ommaya reservoir) catheters. Its radiotherapeutic candidate, Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere (188RNL-BAM), is designed to treat many solid organ cancers including primary and secondary liver cancers via intra-arterial injections.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Plus Therapeutics Appoints New VP of Value Strategy
- Executive Appointment: Plus Therapeutics appointed Dr. Randy H. Goodman as Vice President of Value Strategy & Health Economics on April 13, 2026, leveraging over 20 years of experience in biotechnology and pharmaceuticals to enhance market access and value strategies in CNS cancers.
- Market Access Strategy: Dr. Goodman will lead the development and implementation of market access strategies aimed at supporting the commercial expansion of CNSide and REYOBIQ, ensuring their clinical and economic value is clearly articulated within the healthcare system to enhance product competitiveness.
- Equity Incentive Plan: As an inducement to join the company, Dr. Goodman was granted 9,000 shares of common stock, including 4,500 stock options and 4,500 restricted stock units (RSUs), with an exercise price of $5.41 per share and a 10-year term.
- Industry Influence: Having advised leading global healthcare organizations like Pfizer, Gilead Sciences, and Moderna, Dr. Goodman's expertise in health policy and value-based pricing will provide critical support for Plus Therapeutics in navigating the complex healthcare landscape.
See More
Plus Appoints New Chief Development Officer and Receives FDA Approval
- Executive Appointment: Plus Therapeutics has appointed Eric J. Daniels as Chief Development Officer effective April 20, with Daniels previously serving as CDO at Kiora Pharmaceuticals, overseeing clinical and manufacturing activities, aiming to enhance the company's R&D capabilities for future product development.
- FDA Approval: The company received FDA approval to evaluate its experimental therapy REYOBIQ in pediatric patients with high-grade glioma and ependymoma, marking a strategic expansion into pediatric oncology that could open new market opportunities for the company.
- Stock Performance: Shares of Plus Therapeutics surged 24% following the announcement of the new CDO and the FDA granting orphan drug designation, indicating strong market optimism about the company's future prospects, potentially leading to its best week since late September if gains hold.
- Orphan Drug Designation: REYOBIQ's orphan drug designation provides several potential benefits, including tax credits and fee waivers, which will help reduce R&D costs and enhance the product's competitive position in the market.
See More
Plus Therapeutics Appoints New Chief Development Officer
- Executive Appointment: Plus Therapeutics announced the appointment of Eric J. Daniels, M.D., MBA, as Chief Development Officer effective April 20, 2026, aimed at accelerating product development in the central nervous system cancer sector.
- Extensive Experience: Daniels brings over 20 years of biotechnology experience, having served as Chief Development Officer at Kiora Pharmaceuticals, where he oversaw the entire development portfolio, showcasing his deep background in clinical development and regulatory strategy.
- Strategic Importance: His addition is seen as crucial for advancing REYOBIQ and the broader CNS oncology portfolio, with Plus Therapeutics expecting to enhance the clinical and commercial viability of its products through his expertise.
- Innovative Platform: The company focuses on developing targeted radiotherapeutic platforms for difficult-to-treat CNS cancers, and Daniels' leadership is anticipated to lead to improved patient outcomes, further solidifying the company's market position.
See More
Plus Therapeutics Receives FDA Orphan Drug Designation
- Orphan Drug Designation: Plus Therapeutics' REYOBIQ™ has received Orphan Drug Designation from the FDA for treating pediatric malignant gliomas, marking a significant milestone that supports the company's innovation in rare cancer treatments.
- Market Exclusivity: This designation grants REYOBIQ seven years of market exclusivity, potentially enhancing the company's competitive position in the pediatric cancer treatment market while providing tax incentives for future clinical trials.
- Accelerated Clinical Progress: The orphan drug designation is based on positive clinical data for REYOBIQ in pediatric high-grade gliomas and ependymomas, indicating the drug's potential to improve patient outcomes, especially where existing treatment options are limited.
- Research Funding Support: The company has also received FDA approval for its Investigational New Drug application for REYOBIQ, further advancing its clinical research in pediatric high-grade gliomas and ependymomas, demonstrating ongoing development potential in CNS tumor treatments.
See More
Plus Therapeutics Secures New CPT Code for CNSide Test
- New CPT Code Approval: The American Medical Association has approved a proprietary laboratory analysis code 0640U for Plus Therapeutics' CNSide CSF Tumor Cell Enumeration test, effective July 1, 2026, marking a significant milestone in the company's U.S. commercialization efforts and expected to facilitate broader clinical adoption.
- Streamlined Reimbursement Process: The implementation of the new code simplifies the reimbursement pathway for oncologists and neurologists managing patients with suspected leptomeningeal metastases, thereby enhancing the clinical adoption rate of the CNSide test and strengthening the company's market position in CNS cancer management.
- Facilitating Clinical Adoption: By providing a dedicated billing code, the CNSide test will benefit from standardized claims submission, which not only aids in increasing physician utilization but also supports tracking of test utilization through real-world evidence generation, further driving market acceptance.
- Advancing Commercial Strategy: This coding milestone reinforces Plus Therapeutics' commercial foundation in the U.S. market, which is anticipated to contribute significantly to revenue growth while also supporting the expansion of its therapeutic pipeline.
See More
Plus Therapeutics Secures New Payer Agreement with Highmark
- Expanded Coverage: The agreement with Highmark increases the total covered lives for Plus Therapeutics' CNSide® Tumor Cell Enumeration assay from 67 million to 75 million, making significant progress towards the company's goal of 150 million covered lives by 2026, thereby enhancing patient access across the U.S.
- Reduced Reimbursement Barriers: This agreement is expected to accelerate the adoption of CNSide in oncology centers by lowering reimbursement barriers for ordering physicians, thereby strengthening the company's competitive position in the oncology diagnostics market.
- Clinical Utility Validation: The CNSide® assay has demonstrated superior clinical utility over conventional CSF cytology in nine peer-reviewed publications and the FORESEE clinical trial, enabling earlier and more accurate detection and monitoring of leptomeningeal metastases, which optimizes treatment strategies.
- Significant Economic Benefits: Health economic analyses indicate that early detection with CNSide can reduce overall healthcare costs related to leptomeningeal metastases by approximately 40%, driven by earlier diagnosis and treatment optimization, ultimately improving patient outcomes.
See More
Plus Therapeutics Appoints New VP of Value Strategy
- Executive Appointment: Plus Therapeutics appointed Dr. Randy H. Goodman as Vice President of Value Strategy & Health Economics on April 13, 2026, leveraging over 20 years of experience in biotechnology and pharmaceuticals to enhance market access and value strategies in CNS cancers.
- Market Access Strategy: Dr. Goodman will lead the development and implementation of market access strategies aimed at supporting the commercial expansion of CNSide and REYOBIQ, ensuring their clinical and economic value is clearly articulated within the healthcare system to enhance product competitiveness.
- Equity Incentive Plan: As an inducement to join the company, Dr. Goodman was granted 9,000 shares of common stock, including 4,500 stock options and 4,500 restricted stock units (RSUs), with an exercise price of $5.41 per share and a 10-year term.
- Industry Influence: Having advised leading global healthcare organizations like Pfizer, Gilead Sciences, and Moderna, Dr. Goodman's expertise in health policy and value-based pricing will provide critical support for Plus Therapeutics in navigating the complex healthcare landscape.
See More
Plus Appoints New Chief Development Officer and Receives FDA Approval
- Executive Appointment: Plus Therapeutics has appointed Eric J. Daniels as Chief Development Officer effective April 20, with Daniels previously serving as CDO at Kiora Pharmaceuticals, overseeing clinical and manufacturing activities, aiming to enhance the company's R&D capabilities for future product development.
- FDA Approval: The company received FDA approval to evaluate its experimental therapy REYOBIQ in pediatric patients with high-grade glioma and ependymoma, marking a strategic expansion into pediatric oncology that could open new market opportunities for the company.
- Stock Performance: Shares of Plus Therapeutics surged 24% following the announcement of the new CDO and the FDA granting orphan drug designation, indicating strong market optimism about the company's future prospects, potentially leading to its best week since late September if gains hold.
- Orphan Drug Designation: REYOBIQ's orphan drug designation provides several potential benefits, including tax credits and fee waivers, which will help reduce R&D costs and enhance the product's competitive position in the market.
See More
Plus Therapeutics Appoints New Chief Development Officer
- Executive Appointment: Plus Therapeutics announced the appointment of Eric J. Daniels, M.D., MBA, as Chief Development Officer effective April 20, 2026, aimed at accelerating product development in the central nervous system cancer sector.
- Extensive Experience: Daniels brings over 20 years of biotechnology experience, having served as Chief Development Officer at Kiora Pharmaceuticals, where he oversaw the entire development portfolio, showcasing his deep background in clinical development and regulatory strategy.
- Strategic Importance: His addition is seen as crucial for advancing REYOBIQ and the broader CNS oncology portfolio, with Plus Therapeutics expecting to enhance the clinical and commercial viability of its products through his expertise.
- Innovative Platform: The company focuses on developing targeted radiotherapeutic platforms for difficult-to-treat CNS cancers, and Daniels' leadership is anticipated to lead to improved patient outcomes, further solidifying the company's market position.
See More
Plus Therapeutics Receives FDA Orphan Drug Designation
- Orphan Drug Designation: Plus Therapeutics' REYOBIQ™ has received Orphan Drug Designation from the FDA for treating pediatric malignant gliomas, marking a significant milestone that supports the company's innovation in rare cancer treatments.
- Market Exclusivity: This designation grants REYOBIQ seven years of market exclusivity, potentially enhancing the company's competitive position in the pediatric cancer treatment market while providing tax incentives for future clinical trials.
- Accelerated Clinical Progress: The orphan drug designation is based on positive clinical data for REYOBIQ in pediatric high-grade gliomas and ependymomas, indicating the drug's potential to improve patient outcomes, especially where existing treatment options are limited.
- Research Funding Support: The company has also received FDA approval for its Investigational New Drug application for REYOBIQ, further advancing its clinical research in pediatric high-grade gliomas and ependymomas, demonstrating ongoing development potential in CNS tumor treatments.
See More
Plus Therapeutics Secures New CPT Code for CNSide Test
- New CPT Code Approval: The American Medical Association has approved a proprietary laboratory analysis code 0640U for Plus Therapeutics' CNSide CSF Tumor Cell Enumeration test, effective July 1, 2026, marking a significant milestone in the company's U.S. commercialization efforts and expected to facilitate broader clinical adoption.
- Streamlined Reimbursement Process: The implementation of the new code simplifies the reimbursement pathway for oncologists and neurologists managing patients with suspected leptomeningeal metastases, thereby enhancing the clinical adoption rate of the CNSide test and strengthening the company's market position in CNS cancer management.
- Facilitating Clinical Adoption: By providing a dedicated billing code, the CNSide test will benefit from standardized claims submission, which not only aids in increasing physician utilization but also supports tracking of test utilization through real-world evidence generation, further driving market acceptance.
- Advancing Commercial Strategy: This coding milestone reinforces Plus Therapeutics' commercial foundation in the U.S. market, which is anticipated to contribute significantly to revenue growth while also supporting the expansion of its therapeutic pipeline.
See More
Plus Therapeutics Secures New Payer Agreement with Highmark
- Expanded Coverage: The agreement with Highmark increases the total covered lives for Plus Therapeutics' CNSide® Tumor Cell Enumeration assay from 67 million to 75 million, making significant progress towards the company's goal of 150 million covered lives by 2026, thereby enhancing patient access across the U.S.
- Reduced Reimbursement Barriers: This agreement is expected to accelerate the adoption of CNSide in oncology centers by lowering reimbursement barriers for ordering physicians, thereby strengthening the company's competitive position in the oncology diagnostics market.
- Clinical Utility Validation: The CNSide® assay has demonstrated superior clinical utility over conventional CSF cytology in nine peer-reviewed publications and the FORESEE clinical trial, enabling earlier and more accurate detection and monitoring of leptomeningeal metastases, which optimizes treatment strategies.
- Significant Economic Benefits: Health economic analyses indicate that early detection with CNSide can reduce overall healthcare costs related to leptomeningeal metastases by approximately 40%, driven by earlier diagnosis and treatment optimization, ultimately improving patient outcomes.
See More
