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CNS Pharmaceuticals, Inc. - CNSP STOCK NEWS

Welcome to our dedicated page for CNS Pharmaceuticals news (Ticker: CNSP), a resource for investors and traders seeking the latest updates and insights on CNS Pharmaceuticals stock.

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) is a Houston-based clinical-stage biopharmaceutical company established in 2017. The company is dedicated to developing novel anticancer drug candidates aimed at treating primary and metastatic cancers of the brain and central nervous system (CNS). Their lead drug candidate, Berubicin, is a pioneering anthracycline that distinguishes itself by its ability to cross the blood-brain barrier, offering new hope for patients suffering from glioblastoma multiforme (GBM), an aggressive and currently incurable form of brain cancer.

Berubicin has shown promise in initial trials, with the Phase I clinical trial completing successfully. As of now, Berubicin is being evaluated in a potentially pivotal study. The preliminary safety data was presented at the Society of NeuroOncology (SNO) 28th Annual Meeting, highlighting its comparability in patient demographics and safety with the control arm of the study. Encouragingly, the independent Data Safety Monitoring Board (DSMB) recommended the continuation of the trial without modification after a pre-planned interim futility analysis, signifying Berubicin’s acceptable efficacy and safety profile.

The company has also secured several important collaborations and licensing agreements, including partnerships with Houston Pharmaceuticals, Inc., the University of Texas M.D. Anderson Cancer Center, and WPD Pharmaceuticals Inc. These agreements bolster the development pipeline and provide access to cutting-edge research and development facilities.

Financially, CNS Pharmaceuticals is proactive in securing necessary funding for their research endeavors. Recent public offerings and strategic financial management have ensured operational continuity and support for their ongoing clinical trials. Despite the inherent risks and uncertainties of drug development, CNS Pharmaceuticals remains steadfast in their mission to develop effective cancer therapies.

Beyond Berubicin, CNS Pharmaceuticals continues to explore additional drug candidates and therapies to address various CNS oncology indications. The company's commitment to innovation and patient care positions it as a potential leader in the fight against some of the most challenging cancer types.

For more information, please visit www.CNSPharma.com and connect with the company on Twitter, Facebook, and LinkedIn.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announced its joint sponsorship with WPD Pharmaceuticals for the 2020 Society of NeuroOncology (SNO) Virtual Meeting, held from November 19-21, 2020. As a Supporter level sponsor, CNS will have a virtual booth and its Science Advisory Board member, Dr. Patrick Wen, will participate in a panel discussion on clinical trials. CNS is developing novel treatments for brain cancers, with its lead drug candidate Berubicin showing a 44% disease control rate from a prior Phase 1 trial. A Phase 2 trial is expected to commence by the end of 2020.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announced its participation in A.G.P.'s Virtual Healthcare Symposium on November 19, 2020. The event will feature 1-on-1 virtual meetings for investors to connect with company management. CNS is focused on developing treatments for brain and central nervous system cancers, with its lead candidate, Berubicin, targeting glioblastoma multiforme. CNS holds a worldwide exclusive license for Berubicin, which showed a 44% disease control rate in prior trials. A Phase 2 trial for Berubicin is expected to start by the end of 2020.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) has submitted an Investigational New Drug (IND) application to the FDA for Berubicin, targeting Glioblastoma Multiforme (GBM). The Phase 2 trial aims to evaluate Berubicin's efficacy in patients who failed first-line therapy, comparing it to Lomustine. The trial includes an adaptive design with interim analysis to optimize patient population size. CNS holds an exclusive license for Berubicin and plans to initiate the trial in Q1 2021, pending FDA review.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announced a webcast on November 12, 2020, to discuss the design of its Phase 2 clinical trial for Berubicin, aimed at treating glioblastoma multiforme (GBM). The trial will randomize patients between Berubicin and standard care, incorporating interim assessments for safety and effectiveness. Following promising results from a Phase 1 trial, where a 44% disease control rate was noted, CNS plans to submit an IND application to the FDA. The trial represents a critical step in developing novel treatments for aggressive brain cancers.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announces a video update on November 12, 2020, discussing its Phase 2 trial for Berubicin, aimed at treating glioblastoma multiforme. This trial will randomize patients to receive either Berubicin or standard care, incorporating interim assessments for safety and effectiveness. CNS plans to submit an FDA Investigational New Drug application based on encouraging Phase 1 results, where a 44% disease control rate was observed. The company holds exclusive rights to Berubicin and is advancing its clinical trials for both adult and pediatric patients.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) has announced the completion of manufacturing for its lead drug candidate, Berubicin, by both its U.S. and European manufacturers. This milestone positions the company to file an Investigational New Drug Application (IND) and initiate a U.S. Phase 2 clinical trial for glioblastoma multiforme (GBM) in early 2021. Berubicin received Orphan Drug Designation from the FDA, granting it development advantages. The company has also enhanced its clinical trial setup by engaging key partners and appointing renowned experts to its advisory board.

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CNS Pharmaceuticals (NASDAQ: CNSP) announced the completion of the manufacturing process for its lead drug candidate, Berubicin, aimed at treating glioblastoma multiforme (GBM). This milestone is crucial for filing an Investigational New Drug (IND) application in Q4 2020 and initiating a Phase 2 trial in the U.S. in Q1 2021. The company has engaged various partners for trial preparations and received Orphan Drug Designation from the FDA, potentially leading to market exclusivity. The dual-track manufacturing strategy also aims to mitigate COVID-19-related delays.

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CNS Pharmaceuticals (NASDAQ: CNSP) recently featured a segment on glioblastoma in "Behind the Mystery," aired on Lifetime TV. The segment, which aired on October 12, 2020, showcased the story of a glioblastoma patient and insights from CNS's Scientific Advisory Board member, Dr. Sigmund Hsu. Approximately 13,000 new glioblastoma cases are diagnosed annually in the U.S., making it one of the most aggressive brain cancers. CNS is committed to developing treatments for this disease, with a Phase 2 clinical trial of its lead drug, berubicin, planned for late 2020.

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CNS Pharmaceuticals (NASDAQ: CNSP) announced that its European manufacturer, BSP Pharmaceuticals, has started producing its lead drug candidate, Berubicin, for treating glioblastoma multiforme (GBM), a lethal brain cancer. CEO John Climaco highlighted significant progress towards filing an IND by the end of Q4 2020 and initiating a U.S. Phase 2 trial in Q1 2021. The company implemented a dual-track manufacturing strategy to mitigate COVID-19-related risks. Additionally, the FDA granted Berubicin Orphan Drug Designation, which may provide the company with market exclusivity upon approval.

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CNS Pharmaceuticals (NASDAQ: CNSP) announced a critical achievement in the manufacturing of Berubicin, its lead cancer treatment. Partner NCK A/S has received a Certificate of Analysis for the Active Pharma Ingredient, which allows for large-scale production. This development is expected to ensure drug availability for upcoming Phase 2 clinical trials for glioblastoma, anticipated to start in Q1 2021. CNS holds exclusive rights to Berubicin and aims to advance treatment options for aggressive brain cancers, following promising earlier trial results.

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FAQ

What is the current stock price of CNS Pharmaceuticals (CNSP)?

The current stock price of CNS Pharmaceuticals (CNSP) is $0.1051 as of November 15, 2024.

What is the market cap of CNS Pharmaceuticals (CNSP)?

The market cap of CNS Pharmaceuticals (CNSP) is approximately 4.5M.

What is CNS Pharmaceuticals' primary focus?

CNS Pharmaceuticals specializes in developing novel treatments for primary and metastatic cancers in the brain and central nervous system.

What is Berubicin?

Berubicin is CNS Pharmaceuticals' lead drug candidate, a novel anthracycline designed to treat glioblastoma multiforme (GBM) and other serious brain cancers by crossing the blood-brain barrier.

What makes Berubicin different from other cancer treatments?

Berubicin is the first anthracycline to appear to cross the blood-brain barrier, potentially making it more effective against brain cancers compared to traditional chemotherapy drugs.

What stage is Berubicin currently in?

Berubicin is currently undergoing a potentially pivotal study, with promising interim safety results and a recommendation to continue the trial without modification.

What recent achievements has CNS Pharmaceuticals reported?

CNS Pharmaceuticals recently completed planned enrollment for its Berubicin trial, received DSMB's recommendation to continue the study without modification, and announced positive interim safety data.

Who are CNS Pharmaceuticals' key partners?

CNS Pharmaceuticals has partnerships with Houston Pharmaceuticals, Inc., the University of Texas M.D. Anderson Cancer Center, and WPD Pharmaceuticals Inc.

What financial steps has CNS Pharmaceuticals taken recently?

CNS Pharmaceuticals has conducted public offerings to secure funding for its ongoing clinical trials and research and development efforts.

What designations has the FDA granted to Berubicin?

The FDA has granted Berubicin Fast Track Designation, enabling more frequent interactions for expediting development, and Orphan Drug Designation, which may provide seven years of marketing exclusivity upon approval.

What is the primary endpoint of the Berubicin study?

The primary endpoint is Overall Survival (OS), which the FDA recognizes as a basis for oncology drug approval when a statistically significant improvement is shown.

How does CNS Pharmaceuticals ensure the accuracy and safety of its trials?

CNS Pharmaceuticals relies on an independent Data Safety Monitoring Board (DSMB) to review interim data and ensure the safety and efficacy of its clinical trials.

CNS Pharmaceuticals, Inc.

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