Plus Therapeutics Engages FDA to Advance REYOBIQ Trial Strategy for Leptomeningeal Metastases
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 09 2026
0mins
Should l Buy PSTV?
Source: Newsfilter
- FDA Meeting Outcomes: Plus Therapeutics' Type B meeting with the FDA resulted in constructive discussions regarding the pivotal trial design for REYOBIQ in leptomeningeal metastases, which is expected to expedite clinical development timelines and facilitate application submissions.
- Accelerated Approval Potential: The FDA indicated that while there is insufficient data to support circulating tumor cells as an intermediate clinical endpoint, accelerated approval may be appropriate for the LM indication, highlighting the urgent need for novel therapies.
- Trial Design Recommendations: The FDA recommended a randomized controlled trial design and suggested incorporating multiple histologies into a single trial, which will enhance the clinical relevance and market applicability of the study.
- Commercial Manufacturing Plans: Based on the feedback from the meeting, Plus plans to accelerate REYOBIQ's commercial manufacturing and scale-up activities to meet a potential expedited timeline for market entry, further strengthening its competitive position.
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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: 0.257
Low
2.00
Averages
8.00
High
19.00
Current: 0.257
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.
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- Clinical Trial Progress: The REYOBIQ ReSPECT-LM and ReSPECT-GBM Phase 2 trials are set to report data in Q3 and Q4 2026, respectively, which is expected to provide a basis for FDA submission of pivotal trial designs, facilitating the path to market for new therapies.
- Market Expansion Plans: CNSide aims to cover 150 million US lives through multiple commercial payor agreements and secure Medicare and Medicaid coverage, targeting over 1,250 commercial orders annually to enhance market penetration.
- Innovative Test Launch: CNSide will introduce additional cerebrospinal fluid tumor characterization tests to enrich its platform, aiming to improve management for patients with leptomeningeal metastases and address the urgent need for novel therapies.
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- Clinical Trial Progress: The company is actively conducting the ReSPECT-LM, ReSPECT-GBM, and ReSPECT-Pediatric CNS trials, targeting leptomeningeal metastases, recurrent glioblastoma, and pediatric brain tumors, indicating significant progress in developing radiopharmaceuticals for difficult-to-treat cancers.
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- Funding Support: Plus Therapeutics has completed a $15 million upsized offering aimed at accelerating the REYOBIQ clinical program and the commercialization of the CNSide diagnostic platform, thereby extending its cash runway through 2027 to ensure ongoing operations during critical development phases.
- Clinical Trial Progress: The REYOBIQ ReSPECT-LM and ReSPECT-GBM Phase 2 trials are set to report data in Q3 and Q4 2026, respectively, which is expected to provide a basis for FDA submission of pivotal trial designs, facilitating the path to market for new therapies.
- Market Expansion Plans: CNSide aims to cover 150 million US lives through multiple commercial payor agreements and secure Medicare and Medicaid coverage, targeting over 1,250 commercial orders annually to enhance market penetration.
- Innovative Test Launch: CNSide will introduce additional cerebrospinal fluid tumor characterization tests to enrich its platform, aiming to improve management for patients with leptomeningeal metastases and address the urgent need for novel therapies.
See More
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- Business Update Announcement: Plus Therapeutics will deliver a business update on January 22, 2026, ahead of market open, followed by a conference call to discuss recent advancements in its precision radiotherapeutics program for CNS cancers, demonstrating the company's ongoing commitment to this field.
- Clinical Trial Progress: The company is actively conducting the ReSPECT-LM, ReSPECT-GBM, and ReSPECT-Pediatric CNS trials, targeting leptomeningeal metastases, recurrent glioblastoma, and pediatric brain tumors, indicating significant progress in developing radiopharmaceuticals for difficult-to-treat cancers.
- Strong Financial Position: As of Q3 2025, Plus Therapeutics reported $16.6 million in cash and cash equivalents, providing a solid financial runway for advancing its clinical and regulatory programs, showcasing effective financial management.
- Stock Performance Recovery: PSTV shares have traded between $0.16 and $2.31 over the past year, closing yesterday at $0.29, up 2.31%, and further rising to $0.33 in pre-market trading, up 14.12%, reflecting optimistic market sentiment towards the company's future prospects.
See More
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- Business Update Announcement: Plus Therapeutics will provide a business update before market open on January 22, 2026, aimed at informing investors about recent developments and future plans to bolster market confidence.
- Conference Call Details: The management team will host a conference call at 9:00 AM ET on the same day, expected to discuss company strategy and product pipeline in detail, enhancing investor understanding of future growth prospects.
- Pipeline Progress: The company focuses on developing precision diagnostics and radiopharmaceuticals for central nervous system cancers, particularly in leptomeningeal metastases and recurrent glioblastoma, showing promising clinical potential.
- Role of Subsidiary CNSide: CNSide Diagnostics, a wholly-owned subsidiary of Plus Therapeutics, is dedicated to developing laboratory tests to identify tumor cells that have metastasized to the central nervous system, further strengthening the company's competitive position in cancer management.
See More
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- Small-Cap Outperformance: Despite pressure on large caps, the Russell 2000 index reached new highs last week, reflecting strong earnings prospects for small-cap stocks supported by positive economic data, attracting increased investor interest.
- Market Sentiment Fluctuations: While bank earnings from Goldman Sachs and Morgan Stanley were strong, overall market performance remained volatile due to macro policy uncertainties, indicating a cautious investor outlook on future economic trends.
- Venus Concept Stock Surge: Venus Concept's stock skyrocketed over 500% after Madryn Asset Management disclosed a 91% stake, despite recent revenue declines, as investors expressed optimism about the company's strategic direction and upcoming product innovations.
See More
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- Financing Update: Plus Therapeutics announced the pricing of 39,473,684 units at $0.38 each, expecting to raise approximately $15 million, which will provide fresh capital to advance its precision diagnostics and radiopharmaceutical programs targeting central nervous system cancers.
- Market Performance: Connect Biopharma's stock rose 5.96% to $2.31 without any new news, reflecting ongoing investor interest in its lead candidate rademikibart's new mechanism of action data and strategic priorities for 2026.
- Sector Momentum: ABVC BioPharma's shares increased by 3.37% to $2.15, suggesting that investor interest may be driven by broader momentum in the biotech sector despite the absence of new corporate updates.
- Clinical Progress: Traws Pharma's stock rose 2.82% to $1.82 following its announcement of filing a U.S. IND application for tivoxavir marboxil, further supporting investor optimism around the company's pipeline.
See More
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- High-Risk Stock Surge: High Roller Technologies, Inc. (NYSE:ROLR) shares skyrocketed 289% to $13.64 after announcing a binding Letter of Intent with Crypto.com to launch an event-based prediction markets product in the U.S., demonstrating strong market demand for innovative offerings.
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