Saniona receives positive EU orphan drug designation opinion for SAN2668 in CHD2-related disorder

• Saniona received a positive European Medicines Agency committee opinion recommending orphan drug designation for SAN2668 in CHD2-related neurodevelopmental disorder.
• The recommendation is the first for this disorder in the EU; a final European Commission decision is pending.
• Designation could provide regulatory support, reduced fees and eligibility for 10 years of EU market exclusivity following marketing authorization.
• SAN2668 is a preclinical GABA-A receptor modulator designed for severe pediatric epilepsies, targeting seizure control while minimizing adverse effects.
• No treatments are specifically approved for CHD2-related neurodevelopmental disorder, where most patients remain resistant to multiple anti-seizure medications.

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