Plus Therapeutics Announces Read Out of Type B Meeting with the FDA with Goal of Accelerating Approval of REYOBIQ™ for Leptomeningeal Metastases
Rhea-AI Summary
Plus Therapeutics (NASDAQ:PSTV) completed a Type B meeting with the FDA on Jan 8, 2026 to discuss a potential pivotal trial strategy for REYOBIQ in leptomeningeal metastases (LM).
The FDA indicated accelerated approval may be appropriate for LM but said circulating tumor cells (CTCs) lack sufficient data to serve as an intermediate clinical endpoint. The agency recommended a primary endpoint with established clinical benefit (for example, overall survival), discussed randomized controlled trial designs including an intrathecal chemotherapeutic comparator, and said multiple histologies may be reasonable in one trial. Plus plans to incorporate FDA feedback into its dose‑optimization trial, seek protocol alignment later in 2026, and accelerate manufacturing scale‑up to target pivotal trial readiness in late 2026.
Positive
- FDA indicated accelerated approval may be appropriate for LM
- Company plans to incorporate FDA feedback into dose optimization trial
- Targeting pivotal trial readiness in late 2026
- Plan to accelerate commercial manufacturing scale-up
Negative
- FDA found insufficient data to support CTCs as an intermediate endpoint
- Regulator recommended primary endpoint like overall survival, likely lengthening trials
- FDA discussed a randomized comparator design, increasing trial complexity
News Market Reaction – PSTV
On the day this news was published, PSTV declined 3.73%, reflecting a moderate negative market reaction. Argus tracked a trough of -19.6% from its starting point during tracking. Our momentum scanner triggered 16 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $3M from the company's valuation, bringing the market cap to $80M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
PSTV is up 8.34% while close peers show mixed moves: RADX +0.83%, VRCA +1.12%, BCAB -1.37%, RNXT -3.81%, BRNS roughly flat. Momentum scanner flagged ACRV +7.12% and RNXT +6.93%, but with no same-day peer news and mixed directions across the group, today’s move appears stock-specific.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 11 | Diagnostics expansion | Positive | +7.1% | CNSide assay licensing expanded to cover 48 states and 90% of population. |
| Dec 09 | Hiring & inducements | Positive | +6.3% | Expanded CNSide team and inducement grants to scale operations for large market. |
| Dec 04 | Clinical data update | Positive | +9.8% | Multiple REYOBIQ clinical data presentations in LM and GBM with dosing details. |
| Dec 01 | Conference presentation | Positive | -4.4% | Announcement of SABCS poster spotlight on LM Phase 1 dose-escalation results. |
| Nov 24 | FDA meeting update | Positive | +8.0% | Completed FDA Type B meeting on REYOBIQ LM pivotal trial planning and timelines. |
Across the last five news events, four positive-leaning announcements were followed by positive price reactions, with one notable divergence on a clinical presentation.
Over the past few months, Plus Therapeutics has reported steady progress across its CNS programs and diagnostics. In November–December 2025, multiple REYOBIQ clinical updates and FDA meeting disclosures around leptomeningeal metastases drew positive 24-hour moves of 7.98% and 9.75%. CNSide Diagnostics expansion news in December 2025 also coincided with gains above 6%. Today’s FDA Type B meeting readout fits this pattern of regulatory and clinical milestones supporting the CNS oncology strategy.
Market Pulse Summary
This announcement detailed constructive FDA Type B meeting feedback on REYOBIQ’s pivotal strategy for leptomeningeal metastases, including guidance on endpoints, comparators, and treated populations, with a goal of pivotal readiness by late 2026. Recent history showed multiple REYOBIQ and CNSide milestones with generally positive market responses. Investors may monitor future protocol amendments, manufacturing scale-up progress, and subsequent FDA interactions alongside the company’s capital needs and listing-compliance status from recent filings.
Key Terms
type b meeting regulatory
leptomeningeal metastases medical
circulating tumor cells medical
overall survival medical
patient reported outcomes medical
intrathecal chemotherapeutic medical
AI-generated analysis. Not financial advice.
On track to define optimal dosing interval and advance manufacturing scale up of REYOBIQ for pivotal trial readiness in late 2026
HOUSTON, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, announces the completion of a Type B meeting with the U.S. Food and Drug Administration (FDA) on next steps on REYOBIQ pivotal trial strategy for leptomeningeal metastases (LM). The meeting resulted in constructive discussion with the FDA regarding key elements of the potential pivotal study design for REYOBIQ in LM. Plus intends to incorporate the FDA’s feedback in the current dose optimization trial and seek alignment with the FDA on a revised protocol, likely later this year. The company’s goal is to be ready for a potential pivotal trial following completion of the current dose optimization trial and, ultimately, work towards the potential approval of REYOBIQ for patients affected by LM.
Highlights of FDA responses to the Company's key enquiries:
- Accelerated approval – FDA indicated that accelerated approval may be appropriate for the LM indication, but there are insufficient data to support the use of circulating tumor cells (CTCs) as an intermediate clinical endpoint. FDA and Plus discussed that additional steps would be necessary to validate CTCs as a surrogate endpoint to potentially support other future applications.
- Primary and key endpoints – FDA recommended that the study evaluate an endpoint with established clinical benefit, such as overall survival, while encouraging further study of patient reported outcomes and neurologic function as endpoints that could potentially support a marketing application. FDA and Plus aligned that CTCs could be considered for use as a secondary endpoint.
- Trial design and comparator group - FDA and Plus discussed a randomized controlled trial design approach and that the study may include an intrathecal chemotherapeutic as a comparator, as well as approaches to standardize the comparator and any additional interventions available under the trial protocol.
- Treated populations - FDA conveyed it may be reasonable to incorporate multiple histologies (i.e., multiple underlying disease etiologies) in a single trial.
“Our recent FDA end of phase meeting was constructive, and we hope will help us speed up our clinical development timelines and facilitate faster submission of an application for the approval of REYOBIQ for patients with LM,” said Dr. Marc H. Hedrick, President & Chief Executive of Plus Therapeutics. “As there are no approved drugs for LM, this discussion with the FDA early in clinical development will allow us to make relevant amendments to our current trial protocol and to begin meaningful planning for an anticipated pivotal trial. Furthermore, based in part on this meeting, we will plan to accelerate REYOBIQ commercial manufacturing and scale-up activities to meet an expedited timeline.”
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 Diagnostics, 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. For more information, visit https://www.cnside-dx.com/.
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 the potential study design for REYOBIQ in LM and the Company’s plans to plan to accelerate REYOBIQ commercial manufacturing, among others. 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; 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 position 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 the Company; 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. The Company discusses some of these matters more fully, as well as certain risk factors that could affect its business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including its 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 the Company makes may turn out to be wrong and can be affected by inaccurate assumptions it 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 did Plus Therapeutics announce about REYOBIQ and the FDA on Jan 8, 2026 (PSTV)?
Does the FDA support accelerated approval for REYOBIQ in leptomeningeal metastases (PSTV)?
What primary endpoint did the FDA recommend for a REYOBIQ pivotal trial (PSTV)?
Will Plus change its current REYOBIQ trial after the FDA meeting (PSTV)?
How does the FDA meeting affect REYOBIQ manufacturing plans for PSTV?
