• 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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Saniona AB published the original content used to generate this news brief on November 13, 2026, and is solely responsible for the information contained therein.