CNSide Diagnostics, LLC
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Plus Therapeutics Provides Business Update on REYOBIQ™ Clinical Program and U.S. CNSide® Commercialization
Globenewswire· 2026-01-22 12:45
Core Insights - Plus Therapeutics is focused on scaling up the commercialization of CNSide and preparing for pivotal trials of REYOBIQ in 2026 [2][6] Company Overview - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company based in Houston, Texas, developing targeted radiotherapeutics for challenging CNS cancers [10] - The company aims to enhance clinical outcomes through a combination of image-guided local beta radiation and targeted drug delivery [10] Clinical Programs - REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy designed for CNS tumors, with potential advantages over existing therapies [6] - The REYOBIQ clinical program includes trials for recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer [6][8] - The ReSPECT-LM trial is expected to report data in Q3 2026, while the ReSPECT-GBM trial aims to complete enrollment and align with the FDA on pivotal trial design by Q4 2026 [7] Financial Updates - The company recently completed a $15 million offering to support its core business areas and extend its cash runway through 2027 [2] - Plus Therapeutics aims to cover 150 million US lives under various commercial payor agreements and achieve over 1,250 tests per year in commercial orders [7] CNSide Diagnostics - CNSide Diagnostics, a subsidiary of Plus Therapeutics, develops proprietary tests to identify tumor cells in the CNS, improving management for patients with leptomeningeal metastases [9]
Plus Therapeutics Announces Expansion of CNSide Team and Issuance of Inducement Grants
Globenewswire· 2025-12-09 12:30
Core Insights - Plus Therapeutics, Inc. is expanding its team at CNSide Diagnostics, LLC to enhance its capabilities in the CNS cancer diagnostics market, which is valued at over $6 billion in the U.S. [2][7] - The company is making progress towards a national launch and expanding test coverage, with plans for additional agreements with payors beyond existing contracts with UnitedHealthcare and Humana [2][8] Team Expansion - Mr. Prem Gurnani has been appointed as Senior Director of Lab Operations and Systems Implementation, bringing over 16 years of experience in diagnostics and clinical operations [8] - Ms. Elaine Luckey joins as Director of Quality and Regulatory Affairs, with over 20 years of experience in quality and regulatory affairs in laboratory environments [8] Equity Grants - The company granted stock options to Mr. Gurnani and Ms. Luckey, allowing them to purchase up to 33,750 shares each, with an exercise price equal to the closing stock price on December 4, 2025 [4][6] - Each executive also received 11,250 restricted stock units (RSUs), which will vest over three years, with one-third vesting on January 1, 2027 [5][6] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for challenging CNS cancers, aiming to improve clinical outcomes [8][9] - The company is advancing a pipeline of product candidates, particularly in leptomeningeal metastases and recurrent glioblastoma, supported by strategic partnerships for development and manufacturing [9]
Plus Therapeutics Granted 180-Day Extension to Regain Compliance with Nasdaq’s Minimum Bid Price Requirement
Globenewswire· 2025-11-17 12:30
Core Points - Plus Therapeutics, Inc. has received an additional 180-day extension from Nasdaq to comply with the $1.00 minimum bid price requirement, now having until May 11, 2026, to meet this requirement [1][2] - The extension does not affect the current listing status of the company's common stock on the Nasdaq Capital Market under the symbol "PSTV" [2] - If the closing bid price reaches at least $1.00 per share for 10 consecutive business days during the extension period, Nasdaq will confirm compliance and close the matter [2] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company based in Houston, Texas, focused on developing targeted radiotherapeutics for central nervous system cancers [4] - The company combines image-guided local beta radiation with targeted drug delivery approaches, advancing a pipeline of product candidates, particularly in leptomeningeal metastases and recurrent glioblastoma [4] - Plus Therapeutics has established a supply chain through strategic partnerships to support the development, manufacturing, and potential commercialization of its products [4] Subsidiary Information - CNSide Diagnostics, LLC, a wholly owned subsidiary of Plus Therapeutics, develops proprietary laboratory tests, including CNSide®, to identify tumor cells that have metastasized to the central nervous system [5] - The CNSide® CSF Assay Platform allows for quantitative analysis of cerebrospinal fluid, aiding in the management of patients with leptomeningeal metastases [5]
Plus Therapeutics Announces Successful Accreditation and Certification for Its CNSide® Diagnostics Clinical Laboratory
Globenewswire· 2025-09-18 11:30
Core Insights - CNSide Diagnostics has received accreditation from CMS for its lab in Houston, Texas, meeting CLIA regulations, which is essential for testing human specimens [1][2] - This accreditation is a significant milestone in the company's strategy to expand access to the CNSide CSF assay platform for patients with CNS cancers [2] - The CNSide CSF Assay Platform is designed to identify tumor cells in cerebrospinal fluid, aiding in the management of patients with leptomeningeal metastases [3] Regulatory and Market Access - The certification ensures compliance with proficiency testing, personnel qualifications, and quality control, which are critical for market access [2][6] - Achieving this milestone is necessary for obtaining state licensure in 48 of 50 states and ensuring broad commercial insurance coverage [6] - Lab accreditation is mandatory for enrolling in Medicare and Medicaid programs, which is essential for receiving payments for testing services [6] Company Overview - CNSide Diagnostics is a subsidiary of Plus Therapeutics, focusing on developing proprietary tests for identifying tumor cells that have metastasized to the CNS [3] - Plus Therapeutics is a clinical-stage pharmaceutical company based in Houston, developing targeted radiotherapeutics for challenging CNS cancers [4] - The company is advancing a pipeline of product candidates, particularly in leptomeningeal metastases and recurrent glioblastoma [4]
Plus Therapeutics Regains Compliance with Nasdaq Minimum Stockholders' Equity Requirement
GlobeNewswire News Room· 2025-03-10 11:30
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 ...