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 reports news on its CNS oncology business, which combines precision diagnostics with targeted radiopharmaceutical development for central nervous system cancers. Recurring updates cover REYOBIQ™ (rhenium Re186 obisbemeda), a radiotherapeutic program for indications including leptomeningeal metastases and recurrent glioblastoma, as well as clinical and translational presentations, regulatory designations, manufacturing technology transfer and supply-chain partnerships.
The company’s news also covers the commercial expansion of CNSide®, including payer coverage, Medicare enrollment and reimbursement work for its cerebrospinal fluid assay platform. Corporate updates include leadership appointments, equity inducement grants under Nasdaq rules, financial results, capital actions and listing-compliance matters tied to its Nasdaq-traded common stock.
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.
Plus Therapeutics (Nasdaq: PSTV) reported Q3 2025 results and business updates focused on diagnostics, therapeutics, and capital structure.
Key points: cash and investments $16.6M at Sept 30, 2025; received a $1.9M advance as part of a $17.6M CPRIT grant; regained Nasdaq compliance; UnitedHealthcare national coverage effective Sept 15, 2025 covering >51 million people for the CNSide CSF LDT; CLIA accreditation for Houston lab and CNSide commercially available in Texas since Aug 2025; presented positive ReSPECT-LM Phase 1 results showing feasibility, favorable safety, and an efficacy signal.
Plus Therapeutics (NASDAQ: PSTV) announced commercial progress for its wholly owned subsidiary CNSide Diagnostic on Oct 21, 2025, launching a Cerebrospinal Fluid (CSF) Tumor Cell Enumeration LDT after CLIA accreditation.
Highlights include a national policy agreement with UnitedHealthcare covering ~51 million people, expansion of a purpose-built laboratory in Houston/Texas Medical Center, expanded state license applications, and senior promotions to lead commercial and technical operations.
Plus Therapeutics (Nasdaq: PSTV) has secured a significant national coverage agreement with UnitedHealthcare Insurance Company for its CNSide® Cerebrospinal Fluid Tumor Cell Enumeration test. The agreement, effective September 15, 2025, extends coverage to over 51 million people across the United States.
The CNSide® CSF Assay Platform, which has demonstrated 92% sensitivity and 95% specificity, aids in diagnosing and monitoring patients with leptomeningeal metastases. The test has been validated through 9 peer-reviewed publications and the FORESEE clinical trial, with over 11,000 tests performed at more than 120 U.S. cancer institutions since 2020, influencing treatment decisions in 90% of cases.
Plus Therapeutics (NASDAQ:PSTV) has received a $1.9 million advance payment from the Cancer Prevention and Research Institute of Texas (CPRIT) as part of a previously awarded $17.6 million grant. This marks the second non-dilutive payment following a $1.6 million receipt in July 2025.
The funding will support the clinical development of REYOBIQ™ for the ReSPECT-LM dose optimization trial and the development of CNSide LM diagnostic test. The company expects an additional $1.9 million in funding over the next 12 months. Plus Therapeutics maintains active grants from the National Institutes of Health and Department of Defense, demonstrating strong institutional support for its clinical programs.
Plus Therapeutics (Nasdaq: PSTV) announced that its subsidiary, CNSide Diagnostics, has received CMS accreditation for its Houston-based laboratory. The certification confirms compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations for testing human specimens.
The accreditation is a crucial milestone for the broader market release of the CNSide cerebrospinal fluid (CSF) assay platform, designed for patients with or at risk for CNS cancers. This achievement enables state licensure in 48 states, broad commercial insurance coverage, access to government payor coverage, and expansion of payment coding opportunities.
Plus Therapeutics (NASDAQ:PSTV), a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system (CNS) cancers, will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025.
The company's President and CEO, Marc H. Hedrick, M.D., will engage in a fireside chat with H.C. Wainwright's VP of Equity Research, Sean Lee. The discussion will be available on demand starting September 5, 2025, at 7:00 AM ET for registered conference attendees.
Plus Therapeutics (Nasdaq: PSTV), a clinical-stage pharmaceutical company focused on targeted radiotherapeutics for CNS cancers, has regained compliance with Nasdaq listing requirements. The company received confirmation from Nasdaq on August 22, 2025, verifying compliance with two key criteria: maintaining a market value of listed securities above $35 million and stockholders' equity exceeding $2.5 million.
As a result, PSTV has been granted an extended grace period until November 12, 2025, to meet the $1.00 bid price requirement, replacing the previous September 8 deadline. The company remains under panel monitoring for the Equity Standard through August 22, 2026.
Plus Therapeutics (NASDAQ:PSTV) announced positive results from its ReSPECT-LM Phase 1 trial for REYOBIQ™ in treating leptomeningeal metastases (LM). The trial, involving 29 subjects across 6 cohorts, demonstrated significant efficacy with a 76% radiographic and 87% clinical response rate through day 112.
Key outcomes include 100% reduction in CSF tumor cells at day 28, with five of seven patients showing >80% tumor cell reduction surviving at least one year. The median overall survival reached 9 months, substantially better than the typical 4-month survival rate. The study established a recommended Phase 2 single dose of 44.1 mCi, with no dose-limiting toxicities in cohorts 1-4 and manageable safety profile in higher doses.
[ "Clinical benefit rate exceeded 75% in 3 key outcome measures", "Median overall survival of 9 months vs typical 4 months in literature", "100% reduction in CSF tumor cells observed at day 28", "Favorable safety profile with majority of adverse events being Grade 1 and 2", "Five of seven patients with >80% tumor cell reduction survived at least 1 year" ]Plus Therapeutics (NASDAQ:PSTV), a clinical-stage pharmaceutical company focused on targeted radiotherapeutics for CNS cancers, has successfully addressed its Nasdaq listing compliance concerns. The company reported stockholders' equity of $3 million as of June 30, 2025, exceeding the minimum requirement of $2.5 million under Nasdaq Listing Rule 5550(b)(1).
This development follows a period of non-compliance identified on June 3, 2025, which led to a hearing before the Nasdaq Hearings Panel on July 15, 2025. The Panel granted Plus an extension to demonstrate compliance, and the company's recent Form 10-Q filing on August 14, 2025, confirms its return to compliance with the Equity Rule.