CNS Pharmaceuticals Inc. (NASDAQ: CNSP) stock gained by 2.78% at last close while the CNSP stock price surged by 7.57% in the pre-market trading. CNS Pharmaceuticals is a clinical-stage pharmaceutical business working on anti-cancer medication candidates for the cure of brain and central nervous system tumors, both primary and metastatic. Berubicin, CNSP’s primary medication candidate, is a new anthracycline that seems to penetrate the blood-brain barrier for the first time.
What is happening?
WPD Pharmaceuticals is delighted to announce that CNS Pharmaceuticals which is the company that licenses the drug candidate Berubicin to WPD for 29 countries, primarily in Europe, has been given Fast Track Designation by the US Food and Drug Administration (FDA) for the care of patients with reoccurring glioblastoma multiforme (GBM). CNS also acquired Orphan Drug Designation from the FDA for Berubicin, which is used for the treatment of patients with recurrent GBM, as reported earlier.
Fast Track Designation allows for more regular interactions with the FDA in order to speed up the development and evaluation process for medicines that are supposed to cure serious or life-threatening diseases and have the potential to meet an unmet medical need. Berubicin’s Fast Track Designation from the US Food and Drug Administration is a significant step forward in the development of the drug for the treatment of glioblastoma, the most aggressive, fatal, and treatment-resistant kind of brain cancer. Many patients have few alternatives, and thousands of people die each year as a result of their cancer.CNS now has a faster road to approval for Berubicin, and a clear chance to bring this potentially transformative experimental treatment to market sooner.
The initiation of patient recruitment in CNS’s Berubicin trial for the treatment of recurrent glioblastoma multiforme was recently reported. WPD stands to gain a lot from the progress of Berubicin as a GBM therapy because it has the right to manufacture and market the medication candidate in 29 countries.