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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) announces participation in the Virtual Investor Roundtable Event on November 18, 2021, at 9:00 AM ET. CEO John Climaco and CMO Sandra L. Silberman will present and engage in a moderated discussion followed by a Q&A session. Investors can submit questions live or pre-submit them via the event website. A live video webcast will be available on the company's website, with a replay accessible for one year. CNS specializes in treatments for brain and CNS cancers, focusing on their lead candidate, Berubicin.

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CNS Pharmaceuticals Inc. (NASDAQ: CNSP) announced its Berubicin clinical trial's progress by dosing its first patients for recurrent glioblastoma multiforme (GBM), a severe brain cancer. The pivotal trial, involving 243 patients, aims to evaluate Berubicin’s efficacy against lomustine, focusing on Overall Survival as the primary endpoint. Previous Phase 1 results indicated a 44% clinical benefit rate, with safety consistent with other anthracyclines. CEO John Climaco expressed optimism regarding the trial’s potential and the drug's profile, which appears to cross the blood-brain barrier.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announced the initiation of patient dosing in its clinical trial for Berubicin, targeting recurrent glioblastoma multiforme (GBM). This phase of the study is crucial as GBM treatment options are limited and standard care is ineffective in ~60% of cases. The trial will randomize approximately 243 patients to evaluate Berubicin's effectiveness against lomustine. Berubicin received Fast Track and Orphan Drug Designations from the FDA, highlighting its potential to address unmet medical needs in GBM.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) reported its financial results for Q2 2021, highlighting a net loss of approximately $3.8 million compared to $2.4 million in Q2 2020, primarily due to increased clinical trial preparation costs. The company commenced patient enrollment for a pivotal trial of Berubicin, its lead drug candidate for recurrent glioblastoma multiforme (GBM), which received Fast Track Designation from the FDA. As of June 30, 2021, CNSP holds approximately $10.5 million in cash, expected to fund operations into Q2 2022.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announced significant advancements on July 1, 2021, including the securing of $4.7 million through an ATM offering at an average price of $2.32, extending its cash runway to Q2 2022. The company received Fast Track Designation from the FDA for its lead drug candidate, Berubicin, aimed at treating recurrent glioblastoma multiforme (GBM). Enrollment has begun in a pivotal study aimed at evaluating Berubicin's efficacy and safety, with patient dosing expected to start in Q3 2021, marking key milestones in CNS's clinical and regulatory strategy.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announced that the FDA granted Fast Track Designation for its investigational drug Berubicin, aimed at treating recurrent glioblastoma multiforme (GBM). This designation accelerates the development process for drugs addressing serious conditions with unmet medical needs. CNS has also received Orphan Drug Designation for Berubicin. The company has initiated patient enrollment for a pivotal study of Berubicin, which showed promising responses in prior trials. This progress highlights a critical step in combating the aggressive nature of GBM.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) has been selected for inclusion in the Russell 2000® Index effective June 25, 2021, following the annual reconstitution of the index. This milestone is expected to enhance market awareness as the company advances its clinical programs for glioblastoma multiforme (GBM). The Russell 2000® Index includes approximately 2,000 of the smallest U.S. securities and is widely utilized by investment managers for benchmarking. The addition is anticipated to provide opportunities for increased visibility and value for CNSP.

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CNS Pharmaceuticals (NASDAQ: CNSP) announced the start of patient enrollment for a pivotal study on Berubicin, aimed at treating recurrent glioblastoma multiforme (GBM). This trial will include approximately 210 patients across 35 sites in the U.S. and aims to assess Berubicin's efficacy and safety as compared to standard care. The study's primary endpoint is Overall Survival, a critical measure recognized by the FDA. Additionally, Berubicin has received Orphan Drug Designation from the FDA, granting it seven years of marketing exclusivity upon approval.

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CNS Pharmaceuticals (NASDAQ: CNSP) reported its Q1 2021 financial results, posting a net loss of $3.6 million compared to $2.0 million in Q1 2020. R&D expenses surged to $2.2 million as the company prepares for clinical trials. CEO John Climaco highlighted the upcoming pivotal trial for Berubicin, aimed at treating glioblastoma (GBM), expecting patient enrollment to start in Q2 2021. The FDA has granted Berubicin Orphan Drug Designation, promising seven years of exclusivity post-approval. The company ended the quarter with $11.0 million in cash, funding operations through 2022.

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CNS Pharmaceuticals (NASDAQ: CNSP) announced its participation in the Q2 Virtual Investor Summit on May 18, 2021, at 12:30 PM ET. CEO John Climaco will present key advancements in the company's development of cancer treatments. CNS is focused on Berubicin, targeting glioblastoma multiforme (GBM), with a promising 44% disease control rate in previous trials. The company also aims to start a Phase 2 trial for Berubicin this year. Management will engage in virtual one-on-one meetings with registered investors.

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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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