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 (PSTV), a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system cancers, has successfully regained compliance with Nasdaq's minimum stockholders' equity requirement as of March 7, 2025. The company's common stock will maintain its listing and continue trading on The Nasdaq Capital Market.
Plus Therapeutics (PSTV) has published promising Phase 1 clinical trial results for Rhenium (186Re) Obisbemeda in treating glioblastoma (GBM) in Nature Communications. The study demonstrated significant survival benefits:
Key findings from the trial of 21 patients include:
- Median overall survival of 11 months, exceeding the standard care's 8-month survival rate
- Patients receiving >100 Gy achieved 17-month median survival, compared to 6 months for those receiving 100 GyTreatment doses up to 22.3 mCi showed no dose-limiting toxicity
- Achieved tumor radiation doses up to 739.5 Gy without significant toxicity
The company is currently enrolling patients in its ReSPECT-GBM Phase 2 trial at leading medical centers.
Plus Therapeutics (PSTV) has received Orphan Drug Designation (ODD) from the FDA for Rhenium (186Re) Obisbemeda, targeting leptomeningeal metastases (LM) in lung cancer patients. This designation provides significant benefits including:
- 7 years potential market exclusivity
- Tax credits for qualified clinical trials
- Exemption from regulatory fees including $4.3M PDUFA charge in 2025
- PREA requirements exemption
The company has completed the ReSPECT-LM Phase 1 single-dose trial, establishing the recommended Phase 2 dose. Plus Therapeutics is now proceeding with a Phase 2 single-dose expansion trial and a Phase 1 multiple-dose trial, while working with the FDA to determine the optimal pivotal trial strategy.
Plus Therapeutics (PSTV), a clinical-stage pharmaceutical company focused on targeted radiotherapeutics for CNS cancers, has granted stock options to its new Chief Development Officer, Dr. Michael Rosol.
The equity award consists of options to purchase 30,000 shares of company common stock, with a four-year vesting schedule. One-fourth of the options will vest on the first anniversary, followed by equal monthly installments thereafter. The exercise price is set at the closing price of PSTV's common stock on February 28, 2025.
The options, granted outside the Company's 2020 Incentive Plan but with similar terms, are subject to Dr. Rosol's continued employment. The company has filed a Form S-8 for these equity awards, aiming to align the executive's interests with shareholders.
Plus Therapeutics (PSTV) has announced a private placement expected to generate approximately $15.0 million in gross proceeds. The offering comprises 28,042,140 common units at $0.66 per unit, with 22,727,270 units for new capital and 5,314,870 units exchanged for existing convertible notes.
Each unit includes one share of common stock (or pre-funded warrant), one Series A warrant (exercise price $1.32, 60-month term), and one Series B warrant (exercise price $1.98, 30-month term). The transaction is expected to close around March 4, 2025, subject to conditions including Nasdaq delisting clearance by March 31, 2025.
The proceeds will be used for repaying outstanding promissory notes, warrant repurchases, and general corporate purposes. D. Boral Capital serves as Placement Agent for this offering restricted to accredited investors.
Plus Therapeutics (PSTV) has completed its ReSPECT-LM Phase 1 single-dose escalation trial for Rhenium (186Re) Obisbemeda, determining the recommended Phase 2 dose (RP2D) for treating leptomeningeal metastases (LM).
Key findings include:
- Cohort 4 dose of 44.1 mCi established as the RP2D
- No dose-limiting toxicities observed at the RP2D level
- One patient at Cohort 4 achieved complete response with tumor cells eliminated from cerebrospinal fluid
- Cohort 6 enrollment completed at 75.0 mCi dose
The company is now advancing both a single dose-expansion Phase 2 trial and a multiple-dose Phase 1 trial using 44.1 mCi fractionated into three doses. Plus Therapeutics expects to complete enrollment in both trials this year while engaging with the FDA to define the optimal pivotal trial pathway.
Plus Therapeutics (NASDAQ: PSTV) has announced key leadership appointments for its CNSide Diagnostics subsidiary. Russell Bradley has been named President and General Manager, bringing over 30 years of leadership experience in diagnostics from companies like Abbott Laboratories, Luminex , and Beckman Coulter.
The company has also appointed Dr. Marc Hedrick, Rick Hawkins, and Russell Bradley to the CNSide Board of Directors. Additionally, Dr. Jonathan Stein has been appointed as CNSide Medical Director, bringing 20 years of expertise in molecular diagnostics, assay development, and regulatory compliance.
CNSide Diagnostics plans to begin a pilot market introduction this quarter, focusing on developing improved tools for testing and treating leptomeningeal disease. The subsidiary aims to secure full capitalization to support early access and initial launch plans in the U.S.
Plus Therapeutics (PSTV) has appointed Dr. Michael Rosol as Chief Development Officer to lead the company's clinical, pre-clinical, and biomarker development activities. Dr. Rosol brings 25 years of experience in clinical trial design, operations, and regulatory execution to the company, which is preparing to move from mid-stage to pivotal trials next year.
Previously serving as Chief Medical Officer and Senior Vice President at Navidea Biopharmaceuticals, Dr. Rosol also worked at Novartis Pharmaceuticals leading biomarker development and translational imaging groups. His academic background includes a Ph.D. from Boston University focusing on biomedical and radionuclide imaging, and appointments at prestigious institutions including Harvard Medical School/Massachusetts General Hospital and Mayo Clinic.
Plus Therapeutics (PSTV) has secured $5.7 million in financing through two sources: a $3.7 million private placement from existing investors and a $2.0 million advance payment from the Cancer Prevention and Research Institute of Texas (CPRIT). The funding will support the clinical development of Rhenium (186Re) Obisbemeda for leptomeningeal metastases (LM) and the development of CNSide LM diagnostic test.
The private placement includes secured convertible promissory notes totaling $3,362,251 and warrants to purchase up to 3,002,009 shares at $1.12 per share. The notes mature in one year, bear 10% annual interest, and are convertible into common stock. The $2.0 million CPRIT advance is part of an existing $17.6 million grant, with approximately $5.2 million remaining.
Additionally, the company issued Exchange Notes worth $3,188,922 in exchange for canceling 3,543,247 Series A warrants from May 2024.
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.