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 (PSTV) presented interim Phase 1 data for its ReSPECT-LM clinical trial of Rhenium Obisbemeda in leptomeningeal metastases, focusing on breast cancer patients. Nine of 20 patients with LM primary breast cancer were treated across five dose escalation cohorts. The treatment showed promising results with 88% circulating tumor cell response rate and 75% MRI imaging clinical benefit rate. Only one dose-limiting toxicity was reported, and the median overall survival was 9 months, with 2 patients surviving beyond 600 days. The company plans to initiate a Phase 1b single-dose breast expansion cohort in Q1 2025.
Plus Therapeutics (PSTV) will present Phase 1 interim data for its ReSPECT-LM trial at the 2024 San Antonio Breast Cancer Symposium. The presentation will focus on Rhenium (186Re) Obisbemeda treatment for leptomeningeal metastases (LM) in breast cancer patients.
The presentation, led by Dr. Andrew Brenner from the University of Texas Health Science Center, is scheduled for December 13, 2024. LM is a rare but serious cancer complication affecting the cerebrospinal fluid and leptomeninges, with breast cancer being the most common primary cancer leading to LM. The condition affects 3-5% of breast cancer patients and has a poor prognosis, with 1-year and 2-year survival rates of only 7% and 3%, respectively. Currently, there are no FDA-approved therapies specifically for LM.
Plus Therapeutics (Nasdaq: PSTV) has renewed its Master Services Agreement with Telix IsoTherapeutics Group for the supply of cGMP rhenium-186 (Re-186), a key radioisotope used in their lead radiotherapeutic candidate Rhenium (186Re) Obisbemeda. The five-year renewable agreement ensures reliable supply for late-stage clinical trials and commercial needs. This agreement complements their partnership with SpectronRx for final drug manufacturing, establishing a comprehensive end-to-end supply chain. The agreement focuses on producing aluminum perrhenate radionuclide intermediate and final processing of cGMP Re-186, enabling scalable, just-in-time manufacturing.
Plus Therapeutics (PSTV) presented positive interim data from its ReSPECT-LM Phase 1 trial of Rhenium (186Re) Obisbemeda for leptomeningeal metastases at the 2024 SNO Annual Conference. The trial, involving 20 patients through Cohort 5, demonstrated a 93% response rate in circulating tumor cells, 75% in MRI imaging, and 86% in clinical response. The treatment showed a favorable safety profile with only one dose-limiting toxicity. Median overall survival for Cohorts 1-4 was 9 months, with 6 out of 16 patients alive at analysis. The FDA has agreed to initiate a multiple administration dose escalation trial, with enrollment expected in early 2025.
Plus Therapeutics announced positive results from the FORESEE clinical trial evaluating CNSide™ Cerebrospinal Fluid Assay for leptomeningeal metastases (LM). The trial met its primary endpoint, with CNSide influencing treatment decisions in over 90% of cases. The assay showed 80% sensitivity in detecting tumor cells compared to 29% for standard CSF cytology. Notable findings include CNSide's ability to identify actionable mutations and its revelation of HER2 positivity in 60% of breast cancer patients with HER2-negative primary tumors, significantly impacting treatment strategies.
Plus Therapeutics will present data at the 2024 Society for NeuroOncology Annual Meeting showcasing their CNSide CSF Assay Platform's effectiveness in analyzing leptomeningeal metastases (LM). The study examined 258 CSF samples from 66 LM patients across five institutions.
The analysis revealed significant findings: 88% of patients showed biomarker changes through FISH analysis, with 26 new actionable biomarkers identified. Additionally, 20% of patients demonstrated biomarker changes through ICC analysis, discovering 7 new actionable biomarkers. The research evaluated 14 biomarkers total, with 12 showing changes during treatment.
These findings suggest dynamic mutation profiles in LM, highlighting potential implications for treatment strategies, particularly regarding radiotherapeutics like Rhenium Obisbemeda.
Plus Therapeutics reported Q3 2024 financial results and business updates. Key highlights include FDA agreement to start a Phase 1 trial for Rhenium (186Re) Obisbemeda in leptomeningeal metastases treatment, positive ReSPECT-GBM trial data presentation, and a new manufacturing partnership with SpectronRx. Financial results show cash balance of $4.8M as of September 30, 2024, grant revenue of $4.4M YTD, and operating loss of $10.8M. The company received a $0.9M DoD grant payment and expects a $3.9M CPRIT grant advance within 90 days.
Plus Therapeutics (Nasdaq: PSTV) and SpectronRx have signed a Manufacturing Services Agreement for the production of Rhenium (186Re) Obisbemeda, a radiotherapy for CNS cancers. SpectronRx will utilize its facilities to produce late-stage clinical and commercial supplies of the treatment. The partnership aims to expand Plus' manufacturing capabilities and strengthen supply chain redundancy for upcoming late-stage clinical trials in 2025. SpectronRx operates across five locations with over 170,000 sq ft of radiopharmaceutical manufacturing space and 150 employees, serving 29 countries and collaborating with 31 pharmaceutical companies.
Plus Therapeutics (PSTV), a clinical-stage pharmaceutical company focused on targeted radiotherapeutics for central nervous system cancers, has scheduled its third quarter 2024 financial results announcement for Thursday, November 14, 2024, after market close. The management team will host a conference call and webcast at 5:00 p.m. ET to discuss the results and provide a corporate update. Participants can pre-register through the provided dial-in link and access the webcast through the company's website, where it will remain available for 90 days following the live call.
Plus Therapeutics (PSTV) will present multiple data sets at the 2024 Society for Neuro-Oncology Annual Meeting in Houston, Texas, November 21-24, 2024. The presentations will focus on their leptomeningeal metastases (LM) programs, including results from the ReSPECT-LM Phase 1 clinical trial of Rhenium Obisbemeda and the FORESEE Trial of circulating tumor cells. The company will also host an educational symposium titled 'Novel Targeted Radiotherapies to Manage Leptomeningeal Metastases' featuring clinical experts discussing LM therapeutic and diagnostic programs.
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