Shares of CNS Pharmaceuticals Inc. (CNSP) are rising over 7% in pre-market today, after the company announced that it has filed an application with the U.S. FDA to receive Orphan Drug Designation or ODD for its lead product Berubicin.
Under a prior developer, Berubicin, then known as RTA 744, was granted ODD by the FDA for the treatment of malignant gliomas. In the prior developer's Phase 1 trial of Berubicin, 44% of the patients demonstrated a significant improvement in progression free survival. Additionally, one patient in this study experienced a complete response to his treatment with Berubicin.
"We are excited to announce the Orphan Drug application submission for Berubicin, as it would grant special status and accelerate the development of Berubicin to treat glioblastoma, one of the world's most aggressive forms of cancer," stated John Climaco, CEO of CNS Pharmaceuticals.
The stock has been trading in the range of $1.25 - 5.69 for the past one year, and closed Wednesday's trade at $2.99, down 8 cents or 2.61%. CNSP is currently trading at $3.20, up 21 cents or 7.02% in the pre-market trading session.
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