Saniona Gets Positive EU Orphan Drug Opinion for Neurodevelopmental Disorder Treatment

03:37 AM EST, 11/13/2026 (MT Newswires) -- Saniona (SANION.ST) received a positive opinion from the European Medicines Agency's Committee for Orphan Medicinal Products recommending orphan drug designation for SAN2668 to treat CHD2-related neurodevelopmental disorder. The opinion was forwarded to the European Commission for a final decision, according to a Friday release. If granted, the designation would support the Swedish biopharmaceutical company's development of SAN2668 for severe developmental and epileptic encephalopathies. The designation would also make SAN2668 eligible for incentives, including EMA protocol assistance, reduced regulatory fees and up to 10 years of market exclusivity following marketing authorization in the European Union.