Plus Therapeutics Highlights Three REYOBIQ™ Clinical Data Presentations at 2025 WFNOS/SNO Annual Meeting
Rhea-AI Summary
Plus Therapeutics (Nasdaq: PSTV) presented three clinical data updates at the WFNOS/SNO Annual Meeting (Nov 19-23, 2025) on REYOBIQ (rhenium-186 obisbemeda) in leptomeningeal metastases (LM) and recurrent glioblastoma (rGBM).
Key points: Cohort 1 of the ReSPECT-LM multidose trial began dosing (13.2 mCi) with no dose-limiting toxicity reported; prior single-dose data recommended a Phase 2 dose of 44.1 mCi. ReSPECT-GBM completed Phase 1 (1.0–41.5 mCi) with a 22.3 mCi Phase 2 dose and a maximum absorbed tumor dose of 739.5 Gy; Phase 2 has enrolled 24 of 34 patients. Imaging biomarker analyses showed dose–response correlations and median overall survival of 17 months for patients receiving ≥100 Gy versus 6 months for 100 Gy.
Positive
- Phase 1 GBM max absorbed tumor dose of 739.5 Gy
- Median overall survival 17 months for patients receiving ≥100 Gy
- ReSPECT-GBM Phase 2 enrollment at 24 of planned 34 patients
- ReSPECT-LM Cohort 1 dosed (13.2 mCi) with no dose-limiting toxicity
Negative
- Three patients enrolled in ReSPECT-LM Cohort 1 at data cutoff (small sample)
- Treatment-related Grade 1–2 adverse events include lymphopenia 7.9%, cognitive disorder 7.0%, headache 7.0%
News Market Reaction
On the day this news was published, PSTV gained 9.75%, reflecting a notable positive market reaction. Argus tracked a peak move of +11.0% during that session. Our momentum scanner triggered 12 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $9M to the company's valuation, bringing the market cap to $96M at that time. Trading volume was above average at 1.6x the daily average, suggesting increased trading activity.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Peers showed mixed moves, with RADX up 2.65% while BCAB, BRNS, and RNXT were down and VRCA modestly higher. This pattern points to stock-specific drivers for PSTV rather than a broad biotech move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 09 | Hiring & incentives | Positive | +6.3% | CNSide team expansion and inducement equity grants to support lab scaling. |
| Dec 04 | Clinical data update | Positive | +9.8% | WFNOS/SNO presentations with updated REYOBIQ LM and GBM clinical data. |
| Dec 01 | Conference acceptance | Positive | -4.4% | SABCS poster spotlight acceptance for LM Phase 1 dose-escalation data. |
| Nov 24 | FDA meeting update | Positive | +8.0% | Completion of FDA Type B meeting on REYOBIQ LM pivotal trial planning. |
| Nov 20 | Reimbursement expansion | Positive | -0.3% | Humana national coverage agreement for CNSide CSF assay for CNS cancer. |
Recent clinically focused and diagnostic access news has often been positive in tone, with 3 of 5 events showing aligned positive price reactions and 2 instances where upbeat clinical updates were followed by negative moves.
Over recent months, Plus Therapeutics has steadily built a clinical and diagnostic story around REYOBIQ and CNSide. Positive leptomeningeal metastases data with improved survival and strong response rates were followed by additional clinical presentations and an FDA Type B meeting on future LM development plans. On the diagnostic side, expanded payer coverage and team build-out supported a growing CNSide franchise. The current WFNOS/SNO data extend this trajectory by providing more detailed multidose LM and recurrent GBM results, plus imaging biomarker correlations.
Market Pulse Summary
The stock moved +9.8% in the session following this news. A strong positive reaction aligns with the stock’s tendency to move sharply on REYOBIQ clinical updates, where prior trial news saw average moves of 7.7%. The breadth of LM and recurrent GBM data, including survival and imaging correlations, offered a richer efficacy and safety picture. However, past instances of negative reactions to positive trial news suggest that enthusiasm sometimes faded, so investors later weighed execution, funding needs, and regulatory milestones when reassessing gains.
Key Terms
leptomeningeal metastases medical
glioblastoma medical
MRI medical
SPECT medical
biomarkers medical
adverse events medical
AI-generated analysis. Not financial advice.
Cohort 1 data from multiple dose ReSPECT- Leptomeningeal Metastases (LM) trial
showed no dosage limiting toxicity
ReSPECT-Glioblastoma (GBM) trial of REYOBIQ as a novel therapeutic for recurrent GBM demonstrated promising safety and efficacy signal, supporting continued Phase 2 enrollment and investigation
MRI combined with SPECT imaging biomarkers effectively evaluate overall survival response with REYOBIQ in recurrent GBM treatment and help guide personalized patient planning
HOUSTON, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announces three positive clinical data update presentations at the World Federation of Neuro-Oncology Societies/Society for Neuro-Oncology (WFNOS/SNO) Annual Meeting, November 19-23, 2025 in Honolulu, Hawaii. The World Federation of Neuro-Oncology Societies (WFNOS) and Society for Neuro-Oncology (SNO) advance research, education, and clinical care for patients with tumors of the central nervous system.
“Real world clinical experience with REYOBIQ in both primary and metastatic CNS cancers continues to show a promising safety profile and signs of efficacy,” said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “This expanding clinical data set around REYOBIQ coupled with substantial progress bringing our CNSide diagnostic portfolio to market provides our team at Plus with growing confidence that we can achieve our goal of materially improving survival rates for patients with CNS cancers.”
KEY HIGHLIGHTS:
Phase 1 Multicenter Study of Multiple Doses of Rhenium (186Re) Obisbemeda (Reyobiq) for Leptomeningeal Metastases: Rationale, Design, and Preliminary Cohort 1 Data
Overview:
- Completed ReSPECT-LM single dose trial showed REYOBIQ was well-tolerated up to a maximum tolerated dose of 66mCi, with a recommended phase 2 dose of 44.1 mCi, and absorbed doses delivered of >300 Gy observed
- ReSPECT-LM open label, multidose Phase 1/2 trial initiated to identify maximum tolerated dose across varying dosing intervals and to characterize efficacy of multiple doses at optimal dose selected by assessing response using CNSide CSF tumor cell enumeration test
Response:
- Enrollment in Cohort 1 has begun with delivery of 13.2 mCi at 3 intervals
- Three patients enrolled as of data cutoff: one patient has received all doses without dose limiting toxicity
Next Steps:
- Phase 1b/2a dose optimization trial is enrolling with the ultimate goal of improving outcomes for LM patients
Phase 1/2 ReSPECT-GBM Trial of Rhenium (186Re) Obisbemeda in Recurrent Glioblastoma: Safety and Efficacy from the Phase 1 and Update on Phase 2
Overview:
- Phase 1 dose-escalation study completed, with patients dosed from 1.0 mCi to 41.5 mCi, achieving a maximum absorbed tumor dose of 739.5 Gy. Dose 22.3 mCi was selected as the recommended Phase 2 dose due to its favorable safety profile
- Ongoing Phase 2 study has enrolled 24 of planned 34 patients as of data cutoff; study continues to evaluate safety and efficacy at the Phase 2 recommended dose
Safety:
- Across all patients treated in both Phase 1 and 2, most treatment-related adverse events were Grade 1 or 2, including lymphopenia (
7.9% ), cognitive disorder (7.0% ), and headache (7.0% ), with no treatment-related deaths or study discontinuations due to serious adverse reactions (SARs)
Response:
- Efficacy data from Phase 1 cohorts 1 to 6 showed a median overall survival of 17 months for patients receiving ≥100 Gy, compared to 6 months for those receiving <100 Gy, surpassing historical bevacizumab monotherapy outcomes
- SPECT/CT imaging continues to confirm high tumor-specific radiation retention, with minimal systemic exposure
Next Steps:
- Phase 2 continues to enroll
- REYOBIQ has demonstrated promising safety and efficacy profile, supporting continued investigation as a novel therapeutic for recurrent GBM
Assessment of rhenium-186 obisbemeda (186RNL) therapy for recurrent glioblastoma (rGBM) using MRI and SPECT imaging biomarkers
Overview:
- Phase 1 ReSPECT-GBM showed promising improvements in overall survival
- REYOBIQ efficacy also evaluated using MRI and SPECT imaging biomarkers
Response:
- REYOBIQ dose positively correlates with treatment coverage ratio, time to peak, and progression free survival; negatively correlates with mean transit time and tumor volume
- Based on a Wilcoxon Signed Rank test on 23 patients receiving REYOBIQ, untreated tumor volume was significantly increased relative to treated tumor volume. Overall survival negatively associated with tumor volume
Conclusion:
- MRI combined with SPECT imaging biomarkers effectively evaluate REYOBIQ in recurrent GBM treatment, guiding patient specific planning
Plus Therapeutics and its wholly owned subsidiary, CNSide Diagnostics focused on central nervous system metastases management, each hosted a booth at the WFNOS/SNO Annual Meeting exhibit hall.
About LM
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately
About REYOBIQ™ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year
About CNSide Diagnostic, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://www.plustherapeutics.com.
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company’s ability to maintain the listing of its common stock on Nasdaq; risks related to a halt in trading or delisting of the Company’s common stock on Nasdaq; Medicare and private payors may not provide coverage and reimbursement or may breach, rescind or modify their contracts or reimbursement policies or delay payments; the risk that our products and services may not perform as expected; the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2024, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
investor@plustherapeutics.com
FAQ
What REYOBIQ (PSTV) data were presented at WFNOS/SNO Nov 19-23, 2025?
What is the recommended Phase 2 dose of REYOBIQ for recurrent GBM (PSTV)?
How many patients are enrolled in the ReSPECT-GBM Phase 2 trial (PSTV) as of the data cutoff?
What survival results were reported for REYOBIQ in recurrent GBM (PSTV)?
Were there any dose-limiting toxicities in the ReSPECT-LM Cohort 1 (PSTV)?
What adverse events were observed with REYOBIQ across Phase 1 and 2 (PSTV)?
