Hemispherian's GLIX1 Receives EU Orphan Drug Designation for Glioma

Hemispherian AS has received a positive opinion from the European Medicines Agency's Committee for Orphan Medicinal Products for its lead molecule, GLIX1, targeting glioma, announced in a press release. This designation marks a significant regulatory milestone, recognizing the urgent medical need in treating glioma, a severe brain cancer.

The Orphan Drug Designation (ODD) provides Hemispherian with several incentives, including 10 years of market exclusivity in the EU upon approval, protocol assistance, and eligibility for fee reductions during regulatory submissions. These benefits aim to encourage the development of innovative treatments for rare diseases with high unmet needs.

GLIX1 has shown promising results in non-clinical studies, demonstrating significant tumor reduction and extended survival in animal models. This suggests a clinically relevant advantage over existing treatments, fulfilling the EMA's criteria for "significant benefit."