Welcome to our dedicated page for Plus Therapeutics news (Ticker: PSTV), a resource for investors and traders seeking the latest updates and insights on Plus Therapeutics stock.
Plus Therapeutics, Inc. (NASDAQ: PSTV) generates a steady flow of news as a clinical-stage pharmaceutical and healthcare company focused on targeted radiotherapeutics and precision diagnostics for central nervous system (CNS) cancers. Headquartered in Houston, Texas, the company regularly reports on its clinical trial progress, regulatory interactions, capital markets activity, and expansion of its CNSide Diagnostics subsidiary.
News about Plus Therapeutics often highlights developments related to REYOBIQ™ (rhenium Re186 obisbemeda), its lead investigational radiotherapy for recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancers. Updates include clinical data presentations at major oncology meetings, safety and efficacy findings from the ReSPECT-GBM and ReSPECT-LM trials, and discussions with the U.S. Food and Drug Administration (FDA) on pivotal trial design and potential accelerated approval pathways.
Another key news theme is the company’s CNSide Diagnostics, LLC subsidiary and the CNSide® CSF Assay Platform. Press releases describe new state laboratory licenses, national coverage agreements with major payors, and real-world utilization metrics for the CNSide cerebrospinal fluid Tumor Cell Enumeration test used in managing leptomeningeal metastases.
Investors following PSTV can also expect announcements on financing and listing matters, such as public offerings of common stock and warrants, purchase agreements with institutional investors, and updates on Nasdaq listing compliance related to minimum bid price and equity standards. Corporate governance items, including proxy statements and stockholder meeting results, appear in both news and SEC filings.
This news page aggregates these updates so readers can track Plus Therapeutics’ clinical milestones, diagnostic platform expansion, regulatory communications, and capital markets events in one place. For those researching PSTV, it provides context on how the company is advancing its CNS cancer programs and managing its public company obligations over time.
Plus Therapeutics (NASDAQ: PSTV) priced an upsized underwritten public offering of 39,473,684 units at $0.38 per unit, producing expected gross proceeds of approximately $15 million before underwriting discounts, commissions and expenses. Each unit includes one share of common stock and one warrant exercisable immediately at $0.38 per share and expiring five years from issuance.
The underwriter has a 30‑day option to purchase up to an additional 5,921,052 shares and/or warrants to cover over‑allotments. Proceeds are intended for working capital and general corporate purposes. The offering is expected to close on January 15, 2026, subject to customary closing conditions; Lake Street Capital Markets is sole underwriter. Registration statements were declared effective January 13, 2026.
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.
Plus Therapeutics (Nasdaq: PSTV) announced that CNSide Diagnostics, its wholly owned subsidiary, has received state lab licenses to provide the CNSide® CSF Tumor Cell Enumeration (TCE) laboratory-developed test in California, Rhode Island and Maryland, bringing coverage to 48 of 50 U.S. states and serving over 90% of the U.S. population.
The CNSide® CSF assay supports diagnosis and treatment monitoring for leptomeningeal metastases, reports >11,000 tests at 120+ U.S. cancer institutions since 2020, and cites 92% sensitivity, 95% specificity, and influence on treatment decisions in 90% of cases. Tests are performed at a CLIA-certified facility in Houston and are available exclusively through CNSide Diagnostics.
Plus Therapeutics (Nasdaq: PSTV) announced two hires for its wholly owned subsidiary CNSide Diagnostics and the issuance of inducement equity grants on December 4, 2025. The company said it is scaling lab operations to address a stated $6 billion+ U.S. addressable market for a cerebrospinal fluid assay for metastatic CNS cancers and plans additional payor agreements beyond UnitedHealthcare and Humana.
The hires: Prem Gurnani (Senior Director, Lab Operations) and Elaine Luckey (Director, Quality & Regulatory). Each received options to buy 33,750 shares and 11,250 RSUs with multi-year vesting; option exercise price equals the Dec 4, 2025 closing stock price. A Form S-8 was filed covering the awards.
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.
Plus Therapeutics (Nasdaq: PSTV) announced acceptance of an abstract for a poster spotlight with oral presentation at the San Antonio Breast Cancer Symposium (SABCS) on Dec 12, 2025. The presentation will report Phase 1 dose-escalation results for rhenium (186Re) obisbemeda (186RNL) in patients with leptomeningeal metastases (LM).
Presenter Andrew Brenner, M.D., Ph.D., will present on Dec 12, 2025 at 7:39 AM CST in Hemisfair 3 at the Henry B. Gonzalez Convention Center. LM affects roughly 5% of metastatic cancer patients and has median survival of 2–6 months, underscoring the unmet need for new CNS-targeted therapies.
Plus Therapeutics (Nasdaq: PSTV) announced completion of a Type B meeting with the U.S. Food and Drug Administration on November 7, 2025 to discuss clinical development plans for REYOBIQ in leptomeningeal metastases (LM), including design of a planned pivotal/registrational trial. The company described the meeting as constructive and said it will receive FDA meeting minutes, provide an update and guidance on next steps early in 2026, and implement focused amendments to its LM trial to align the development timeline with FDA recommendations.
Plus Therapeutics (Nasdaq: PSTV) announced that its subsidiary CNSide Diagnostics signed a national coverage agreement with Humana effective October 29, 2025, adding coverage for approximately 16 million people and bringing total CNSide CSF TCE LDT policy coverage to 67 million in the U.S.
The CNSide® Cerebrospinal Fluid Tumor Cell Enumeration laboratory developed test supports rapid diagnosis, treatment monitoring, and guidance for leptomeningeal metastases. Performance and adoption details: >11,000 tests at >120 U.S. cancer institutions since 2020; 92% sensitivity, 95% specificity; influenced treatment decisions in 90% of cases. The test is available exclusively through CNSide Diagnostics as a U.S. testing service.
Plus Therapeutics (Nasdaq: PSTV) received a 180-day extension from Nasdaq to regain compliance with the $1.00 minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2).
The extension does not affect the company's current listing and gives Plus until May 11, 2026 to achieve a closing bid of at least $1.00 for a minimum of 10 consecutive business days, at which point Nasdaq would confirm compliance in writing. The company cautioned there is no assurance it will regain compliance even if other listing requirements remain met.
Plus Therapeutics (Nasdaq: PSTV) will present ReSPECT-LM clinical trial results at the 40th SITC Annual Meeting and MRF Brain Metastases Summit on November 9, 2025.
Phase 1 single-dose escalation data reported at SNO/ASCO 2025 showed clinical benefit rate >75% across three outcome measures, RNA sequencing and circulating tumor cell reductions consistent with tumor cell death, and no dose-limiting toxicities up to the recommended Phase 2 dose of 44.1 mCi. REYOBIQ has received FDA Fast Track and Orphan Drug designations and enrollment in the ReSPECT-LM Dose Optimization Trial is ongoing.
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