Hemispherian Receives FDA Orphan Drug Status for GLIX1 for the Treatment of Malignant Glioma
Oslo, Norway, July 1, 2025 – Norwegian biotech company Hemispherian AS has reached a significant milestone: The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to the active substance GLIX1 for the treatment of malignant glioma, a group of serious brain tumors including glioblastoma. This status underscores GLIX1's potential to offer significant clinical benefit over existing therapies and addresses the urgent medical need in this rare, life-threatening disease. "The FDA's recognition confirms our scientific approach and our mission to develop innovative solutions for oncological challenges," explained Zeno Albisser, CEO of Hemispherian. "GLIX1 is a novel small molecule drug with a unique mechanism of action. The support from US and EU regulatory authorities strengthens our goal of offering a new treatment option for patients with malignant glioma." Details of the Orphan Drug Award The FDA grants ODD in accordance with Section 526 of the Federal Food,...
