Plus Therapeutics Inc Stock Price, News & Analysis

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.

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.