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, Inc. (Nasdaq: PSTV) announced that CEO Marc Hedrick will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 14, 2022, at 2:00 p.m. ET, in New York City. The presentation will focus on the company’s development of targeted radiotherapeutics for rare cancers. Investors interested in meetings with management should contact the conference coordinator. An archived replay of the presentation will be available on the Plus Therapeutics website for 90 days post-event.
Plus Therapeutics (PSTV) announced the initiation of the ReSPECT-GBM Phase 2 trial, focusing on the Rhenium-186 NanoLiposome (186RNL) for treating recurrent glioblastoma (GBM). The FDA has approved the trial, emphasizing dose exploration and the collection of safety and efficacy data. A future registrational trial will prioritize overall survival as the main endpoint. The trial's principal investigator will provide updates at the ESMO Congress. Plus Therapeutics continues to develop innovative targeted radiotherapeutics for challenging cancers, backed by NIH and CPRIT funding.
Plus Therapeutics, Inc. (PSTV) has announced a significant update following a Type C meeting with the FDA regarding the cGMP production of its investigational radiotherapeutic, 186RNL, aimed at treating recurrent glioblastoma. The FDA supports the company’s CMC practices, aligning with its proposed manufacturing and release strategies. This endorsement is crucial as Plus Therapeutics prepares for ongoing and future ReSPECT™ clinical trials, with cGMP 186RNL expected to be available in the second half of 2022. The company emphasizes that this regulatory clarity mitigates risks of potential delays.
Plus Therapeutics, Inc. (PSTV) has announced an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2022 regarding its Phase 1/2a ReSPECT-GBM™ clinical trial. The trial evaluates Rhenium-186 NanoLiposome (186RNL) for treating recurrent glioblastoma. The presentation is scheduled for September 9, 2022, at 14:00 CEST, led by Dr. Andrew J. Brenner. This investigation aims to demonstrate the safety and efficacy of 186RNL in delivering high doses of radiation directly to tumors through Convection Enhanced Delivery (CED).
Plus Therapeutics (PSTV) has secured a $17.6 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to advance Rhenium-186 NanoLiposome (186RNL) aimed at treating leptomeningeal metastases. This funding will cover a significant portion of the developmental costs for the next three years. Additionally, the clinical trial for 186RNL continues to progress with Cohort 1 enrollment completed, demonstrating no dose-limiting toxicities. The therapy has received FDA Fast Track designation, indicating significant potential in addressing this severe cancer complication.
Plus Therapeutics, Inc. (PSTV) announced a share repurchase program authorized for up to $2.0 million of its outstanding common stock, signaling strong confidence in its long-term strategy and balance sheet. The program will be funded through available cash and executed based on market conditions over the next 12 months. The company intends to utilize Rule 10b5-1 trading plans for buybacks, while maintaining flexibility to adjust the program as needed. This initiative underlines Plus Therapeutics' commitment to enhancing shareholder value.
Plus Therapeutics (PSTV) showcased positive findings from ongoing trials of Rhenium-186 Nanoliposome (186RNL) for treating recurrent glioblastoma (GBM) and leptomeningeal metastases at the 2022 CNS Clinical Trials Conference. The Phase 1/2a trial reported safe administration of 186RNL, demonstrating a substantial decrease in cerebrospinal fluid (CSF) cell count in treated patients. Additionally, significant overall survival benefits were noted in GBM patients receiving high radiation doses. The company aims to continue clinical evaluations and further dose escalations.
Plus Therapeutics (PSTV) announced the presentation of data from two clinical trials targeting recurrent glioblastoma and leptomeningeal metastases at the 2022 CNS Clinical Trials and Brain Metastases Conference on August 12-13, 2022. The oral presentation will focus on the safety and feasibility of Rhenium-186 Nanoliposome in leptomeningeal metastases, while a poster will cover its use in recurrent glioma as part of the ReSPECT Phase 1 Trial. This showcases advancements in innovative, targeted radiotherapeutics for challenging cancer types.
Plus Therapeutics (PSTV) announced that Dr. Norman LaFrance will present on their investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome (186RNL), at the Targeted Radiopharmaceuticals Summit in Boston on July 27, 2022. The presentation is titled ‘Radiolabeled NanoLiposomes: A Novel Targeted Treatment for Rare and Central Nervous System Cancers’, and will provide updates on the U.S. ReSPECT clinical trials. Plus Therapeutics focuses on developing innovative cancer therapies, utilizing advanced nanotechnology for drug delivery.
Plus Therapeutics (PSTV) announced the completion of Cohort 1 enrollment in the ReSPECT-LM Phase 1/2a trial for 186RNL, targeting leptomeningeal metastases. The company achieved key manufacturing objectives and presented positive interim data on 186RNL for glioblastoma. Financially, cash stood at $18.1 million with a net loss of $5.3 million for Q2 2022. Operating expenses rose to $5.1 million due to CMC development costs. The company plans multiple data presentations and aims to finalize GMP production for ongoing clinical trials by the end of 2022.