CNS Pharmaceuticals Stock Price, News & Analysis

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.

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.

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.

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.

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.

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announced that CEO John Climaco will present at the Emerging Growth Virtual Conference on March 17-18, 2021. The event will feature discussions on glioblastoma, with Climaco participating in a panel on March 17 from 9:30-10:30 am ET. CNS is focused on developing treatments for brain and central nervous system cancers, including their lead drug candidate, Berubicin, aimed at glioblastoma multiforme. CNS plans to initiate a Phase 2 trial for Berubicin in the U.S. in 2021.

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announced that CEO John Climaco will present at the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. The company specializes in developing treatments for brain cancers. Participants can join virtual one-on-one meetings with management and view a video webcast of the presentation starting March 9 at 7:00 AM ET. CNS's lead drug candidate, Berubicin, targets glioblastoma multiforme and has shown a 44% response rate in previous trials. A Phase 2 trial is expected in 2021.

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announced that its clinical program for Berubicin, a novel treatment targeting glioblastoma multiforme (GBM), is set to start enrolling patients in March 2021. Berubicin is the first anthracycline capable of crossing the blood-brain barrier, aiming to improve outcomes for patients with this aggressive cancer. The study will involve approximately 35 clinical sites, with 21 currently confirmed. The primary endpoint is Overall Survival, with results expected to offer vital data for FDA approval. The FDA has granted Orphan Drug designation for Berubicin, ensuring marketing exclusivity.

On February 18, 2021, CNS Pharmaceuticals (NASDAQ: CNSP) announced that WPD Pharmaceuticals received a positive opinion from the Lower Silesian Medical Chamber Ethics Committee for its Berubicin clinical trial targeting Glioblastoma Multiforme (GBM). CNS also obtained Central IRB approval for its CNS-201 trial, marking a significant step in the collaborative development of Berubicin. The U.S. FDA has approved CNS's Investigational New Drug application for Berubicin, with a Phase 2 trial set to commence in Q1 2021. WPD plans to initiate multiple trials in 2021, supported by a $6 million grant.