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COPENHAGEN - Danish radiopharmaceuticals company Curasight A/S (CPH:CURAS), a small-cap biotech firm valued at $25.47 million, announced Tuesday that the European Medicines Agency (EMA) has approved its clinical trial application for uTREAT in a Phase 1 study targeting glioblastoma, an aggressive form of brain cancer. According to InvestingPro data, while the company is not yet profitable, it maintains a moderate debt level with total debt to capital ratio of just 6%.
The trial, which will investigate uTREAT as a targeted radiopharmaceutical therapy in patients with newly diagnosed glioblastoma, represents the first clinical investigation of the company’s treatment platform. Curasight expects to dose the first patient before the end of 2025.
With this approval, Curasight is now advancing both its diagnostic platform (uTRACE) and therapeutic platform (uTREAT) in clinical development.
"The approval of the CTA underlines the strong progress being made in developing uTREAT as a potential more targeted therapeutic solution for patients with aggressive brain cancer, where there is a strong unmet medical need," said Ulrich Krasilnikoff, CEO of Curasight. The company’s stock, currently trading at $0.60, has shown mixed performance, with a strong return over the last month despite falling over 60% in the past six months. InvestingPro analysis suggests the stock may be undervalued at current levels.
The company’s approach combines diagnostic imaging and targeted treatment through its uPAR theranostic platform. According to the press release, a recent investigator-initiated Phase II study showed that 94% of Grade 4 gliomas, including glioblastomas, were uPAR-positive. Want deeper insights? InvestingPro subscribers have access to over 10 additional ProTips and comprehensive financial metrics to evaluate Curasight’s potential.
Glioblastoma affects approximately 30,000 patients annually in the US and EU, with a poor prognosis where only 5% of patients survive five years after diagnosis. The company suggests uTREAT could potentially replace or reduce external beam radiation, potentially lowering side effects to healthy brain tissue.
The information was provided in a company press release.
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