HOUSTON, March 10, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company” or “Plus Therapeutics”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that on March 7, 2025 the Company received confirmation from Nasdaq that the Company has regained compliance with Nasdaq’s minimum stockholders’ equity requirement. The Company’s common stock will continue to be listed and ...

HOUSTON, March 10, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company” or “Plus Therapeutics”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that on March 7, 2025 the Company received confirmation from Nasdaq that the Company has regained compliance with Nasdaq’s minimum stockholders’ equity requirement. The Company’s common stock will continue to be listed and ...

HOUSTON, March 10, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (NASDAQ:PSTV) (the "Company" or "Plus Therapeutics"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that on March 7, 2025 the Company received confirmation from Nasdaq that the Company has regained compliance with Nasdaq's minimum stockholders' equity requirement. The Company's common stock will continue to be listed and t ...

Core Viewpoint - Plus Therapeutics, Inc. (PSTV) experienced a significant stock increase of 311.4% on March 6 after receiving Orphan Drug Designation (ODD) from the FDA for its lead candidate, rhenium (186Re) obisbemeda, aimed at treating leptomeningeal metastases in lung cancer patients [1][2]. Company Developments - The FDA's ODD supports the development of treatments for rare disorders affecting fewer than 200,000 individuals in the U.S., providing seven years of market exclusivity post-approval, tax credits for clinical studies, and exemptions from certain FDA fees, including a $4.3 million fee in 2025 [2]. - Rhenium (186Re) obisbemeda is a novel injectable radiotherapy designed for targeted high-dose radiation in central nervous system tumors, potentially improving patient outcomes [4]. - PSTV has completed enrollment in the ReSPECT-LM phase I study, assessing the safety and efficacy of rhenium (186Re) obisbemeda in patients with leptomeningeal metastases, and is advancing to phase II and phase I multiple-dose studies [5]. - The company is also evaluating rhenium (186Re) obisbemeda in the phase I/II ReSPECT-GBM study for recurrent glioblastoma and plans to develop it for pediatric brain cancers [6]. Market Performance - Over the past year, PSTV shares have declined by 14.8%, while the industry average decrease was 9.9% [3].

Core Insights - Rhenium (Re) Obisbemeda shows promising safety and efficacy for glioblastoma patients, with a median overall survival of 17 months for those receiving doses greater than 100 Gy, compared to 8 months with standard care [1][7] - The publication of Phase 1 trial results in a high-impact journal validates the clinical program and supports the ongoing ReSPECT-GBM Phase 2 trial [2] Company Overview - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system cancers, particularly recurrent glioblastoma and leptomeningeal metastases [9] - The company utilizes advanced platform technologies to enhance patient outcomes through targeted drug delivery and image-guided local beta radiation [9] Clinical Trial Details - The ReSPECT-GBM trial is currently enrolling patients and aims to provide a much-needed treatment option for recurrent glioblastoma, which has limited existing therapies [2][3] - Rhenium (Re) Obisbemeda is being evaluated in clinical trials, including ReSPECT-GBM and ReSPECT-LM, with significant funding support from the National Cancer Institute and a $17.6 million grant from the Cancer Prevention & Research Institute of Texas [5] Disease Context - Glioblastoma affects approximately 15,000 patients annually in the U.S. and is characterized by a poor prognosis, with an average life expectancy of less than 24 months [4] - Current treatments for recurrent glioblastoma offer marginal survival benefits and are associated with significant side effects, highlighting the need for more effective therapies [4] Treatment Mechanism - Rhenium (Re) Obisbemeda is a novel injectable radiotherapy designed to deliver high doses of targeted radiation directly to CNS tumors, potentially improving outcomes compared to existing therapies [5] - The treatment utilizes Rhenium-186, which has a short half-life and is effective for both destroying cancerous tissue and real-time imaging [5]

Core Viewpoint - Plus Therapeutics has received Orphan Drug Designation from the FDA for Rhenium (186Re) Obisbemeda, aimed at treating leptomeningeal metastases in lung cancer patients, highlighting the urgent need for new therapies in this underserved area [1][2]. Company Overview - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system cancers, with a pipeline that includes treatments for recurrent glioblastoma and leptomeningeal metastases [6][7]. - The company utilizes advanced platform technologies that combine image-guided local beta radiation and targeted drug delivery approaches to enhance clinical outcomes for patients [6]. Product Development - Rhenium (186Re) Obisbemeda is a novel injectable radiotherapy designed to deliver targeted high-dose radiation to CNS tumors, potentially improving patient outcomes compared to existing therapies [5]. - The company has completed the ReSPECT-LM Phase 1 single-dose trial, establishing the recommended Phase 2 dose, and is advancing into further clinical trials [3]. Market Context - Leptomeningeal metastases (LM) is a rare but serious complication of cancer, affecting approximately 5% of cancer patients, with a particularly high incidence in lung cancer and breast cancer [4]. - There are currently no FDA-approved therapies specifically for LM patients, emphasizing the critical need for innovative treatments in this area [4]. Regulatory Milestones - The Orphan Drug Designation provides several benefits, including seven years of market exclusivity, tax credits for clinical trials, and exemptions from significant regulatory fees, which can facilitate the development and commercialization of Rhenium (186Re) Obisbemeda [2].

HOUSTON, March 04, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced the pricing of a private placement with gross proceeds to the Company expected to be approximately $15.0 million. “This financing coupled with ongoing grant support strengthens our ability to rapidly advance our CNS cancer therapies,” said ...

AUSTIN, Texas, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (NASDAQ:PSTV) (the "Company" or "Plus Therapeutics"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced the completion of the ReSPECT-LM Phase 1 single-dose escalation trial, having determined an RP2D. The ReSPECT-LM single-dose escalation trial assessed the safety, tolerability, and potential efficacy of intratheca ...

Core Insights - Plus Therapeutics, Inc. has appointed Russell Bradley as President and General Manager of its subsidiary CNSide Diagnostics, LLC, aiming to enhance its operations in the diagnostic landscape for CNS cancers [2][3] - The company has also appointed Dr. Marc Hedrick, Mr. Rick Hawkins, and Mr. Russell Bradley to the CNSide Board of Directors, while Dr. Jonathan Stein has been named Medical Director [2][3] Company Developments - Russell Bradley brings over 30 years of leadership experience in diagnostics and life sciences, having held senior roles at Abbott Laboratories, Luminex Corporation, and Beckman Coulter, and is expected to make an immediate impact on CNSide [3] - The immediate priority for CNSide Diagnostics is to support early access and initial launch plans in the U.S. for its diagnostic tools targeting leptomeningeal disease [4] Product and Market Focus - CNSide Diagnostics develops proprietary laboratory-developed tests designed to identify tumor cells that have metastasized to the central nervous system, particularly for patients with carcinomas and melanomas [6] - The CNSide platform includes four laboratory-developed tests for treatment selection and monitoring of patients with leptomeningeal metastases, utilizing both cellular and molecular assays [7][8] - The CNSide CSF tumor cell enumeration LDT is currently being used in the ReSPECT-LM trial and is expected to be commercially available in 2025 [8] Industry Context - Leptomeningeal metastases (LM) is a rare but serious complication of cancer, affecting approximately 5% of cancer patients, with a particularly high incidence in breast cancer patients [5] - There are currently no FDA-approved therapies specifically for LM patients, highlighting a significant unmet medical need in the market [5]

Core Insights - Plus Therapeutics, Inc. has appointed Russell Bradley as President and General Manager of its subsidiary CNSide Diagnostics, LLC, aiming to enhance its operations in the diagnostic landscape for CNS cancers [2][3] - The company has also appointed Dr. Marc Hedrick, Mr. Rick Hawkins, and Mr. Russell Bradley to the CNSide Board of Directors, with Dr. Jonathan Stein as the new Medical Director [2][3] Company Developments - Russell Bradley brings over 30 years of experience in diagnostics and life sciences, having held senior roles at Abbott Laboratories, Luminex Corporation, and Beckman Coulter, and is expected to make an immediate impact on CNSide [3] - The immediate priority for CNSide Diagnostics is to support early access and initial launch plans in the U.S. for its diagnostic tools targeting leptomeningeal disease [4] Product and Market Focus - CNSide Diagnostics is focused on developing proprietary laboratory-developed tests to identify tumor cells that have metastasized to the central nervous system, particularly for patients with carcinomas and melanomas [6] - The CNSide platform includes four laboratory-developed tests for treatment selection and monitoring of patients with leptomeningeal metastases, utilizing both cellular and molecular assays [7][8] Industry Context - Leptomeningeal metastases (LM) is a rare but serious complication of cancer, affecting approximately 5% of cancer patients, with a particularly high incidence in breast cancer patients [5] - There are currently no FDA-approved therapies specifically for LM patients, highlighting a significant unmet medical need in this area [5]