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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, a biopharmaceutical company, announced it has received approval from the Italian Medicines Agency for its global trial evaluating Berubicin, a novel treatment for recurrent glioblastoma multiforme (GBM). The trial, which aims to assess the efficacy of Berubicin compared to the standard treatment Lomustine, is set to include 60 clinical sites across the U.S. and Europe, with 41 already opened. A key interim analysis is planned for Q3 2023, focusing on patient survival rates. CNS has been granted Fast Track Designation and Orphan Drug Designation from the FDA for Berubicin, potentially expediting its development and providing marketing exclusivity. The company emphasizes its commitment to addressing unmet medical needs in treating GBM through this ongoing clinical trial.

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CNS Pharmaceuticals reported significant advancements in its Phase 2 trial for Berubicin, a treatment for recurrent glioblastoma multiforme (GBM). The company has opened 41 clinical trial sites globally, with results from a pre-planned interim analysis expected in Q3 2023. Financially, CNSP reported a net loss of $15.3 million for 2022, up from $14.5 million in 2021, mainly due to increased administrative costs. R&D expenses decreased slightly to $9.3 million. As of December 31, 2022, the company had approximately $10.1 million in cash, enough to fund operations through Q3 2023.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) will present at the Virtual Investor GBM Spotlight Event on April 4, 2023, at 3:00 PM ET. CEO John Climaco and Key Opinion Leader Michael Weller, MD, will discuss the company's lead candidate, Berubicin, for treating recurrent glioblastoma multiforme (GBM). This event highlights CNSP's commitment to addressing the critical need for effective treatments in neuro-oncology. A live webcast will be available, followed by a replay for 90 days.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announced it has no financial exposure to Silicon Valley Bank (SVB), which the Federal Deposit Insurance Corp. took control of due to liquidity concerns. CNSP confirmed that it does not hold any deposits or investments at SVB, reassuring investors about its financial stability. The company focuses on developing innovative treatments for primary and metastatic cancers in the brain and central nervous system. Its lead drug candidate, Berubicin, is designed to treat serious brain cancer, including glioblastoma multiforme (GBM).

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announced the enrollment of the first patient in Switzerland for its global trial evaluating Berubicin in treating recurrent glioblastoma multiforme (GBM). The trial has opened 40 of 59 planned sites in the U.S., Italy, France, Spain, and Switzerland, with an interim analysis expected mid-2023 when 30-50% of subjects reach primary endpoints. Berubicin, an anthracycline that crosses the blood-brain barrier, aims to address the significant unmet need in GBM treatment. The FDA has granted Fast Track and Orphan Drug designations to Berubicin, facilitating expedited development and potential marketing exclusivity.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) has announced the enrollment of the first patient in Spain for its global trial evaluating Berubicin for treating recurrent glioblastoma multiforme (GBM). The trial, which aims to assess Berubicin's efficacy and safety, has opened 37 of the 59 planned clinical sites across several countries, including the U.S., Italy, France, Spain, and Switzerland. An interim analysis is expected mid-2023 after 30-50% of subjects reach the primary endpoint. The FDA has granted Berubicin Fast Track and Orphan Drug Designations, enhancing its development process and potential market exclusivity.

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CNS Pharmaceuticals (NASDAQ: CNSP) has announced an investigator-initiated Phase 1b/2 clinical trial evaluating its drug, Berubicin, for treating newly diagnosed and relapsed/refractory primary central nervous system lymphoma (PCNSL) and non-Hodgkin's lymphoma with CNS involvement. Conducted at Pomeranian Medical University in Poland, the trial will assess the safety, efficacy, and pharmacokinetics of Berubicin, with the aim of determining the recommended Phase 2 dose. Approximately 60 patients are expected to participate in this single-center study, demonstrating CNSP's commitment to addressing the unmet needs in CNS oncology.

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CNS Pharmaceuticals is set to present at the Virtual Investor 2023 Companies to Watch Event on January 18, 2023, at 10:00 AM ET. CEO John Climaco will lead the presentation, showcasing the company's innovative pipeline for treating brain and central nervous system cancers, primarily focusing on their lead drug candidate, Berubicin. This anthracycline is notable for its ability to cross the blood-brain barrier and targets aggressive brain cancers like glioblastoma multiforme. A live webcast will be available on the company’s website, with a replay accessible for 90 days.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) has appointed Faith L. Charles as the new Chair of its Board of Directors. Charles brings over 30 years of life sciences experience and currently leads the Life Sciences practice at Thompson Hine, LLP. Her expertise spans corporate governance, capital markets, and strategic collaborations. CNS aims to leverage her knowledge to advance its clinical development, particularly for its lead drug candidate, Berubicin, targeting brain and CNS cancers. CEO John Climaco expressed optimism about her impact on growth and shareholder value.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) has announced preliminary results from its pivotal trial of Berubicin, targeting recurrent glioblastoma multiforme (GBM). Data presented at the Society for Neuro-Oncology's annual meeting indicates a balanced patient population for efficacy comparison against Lomustine. As of October 17, 2022, 49 patients were enrolled, with 35 receiving Berubicin. The trial aims for an interim analysis in mid-2023, assessing overall survival and safety. Updated enrollment shows significant progress, now at 67 patients, highlighting the critical need for effective GBM treatments.

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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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