MRNS - Marinus' seizure drug Ztalmy inches toward EU approval with EMA nod

2023-05-26 08:20:12 ET

• A committee of the European Medicines Agency (EMA) recommended the approval of Marinus Pharmaceuticals' ( NASDAQ: MRNS ) Ztalmy (ganaxolone) to treat epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder.
• The genetic disorder is characterized by seizures beginning in infancy.
• the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Ztalmy as an adjunctive treatment of epileptic seizures linked with CDKL5 deficiency disorder in patients two to 17 years of age.
• Ztalmy may be continued in patients 18 years of age and older, the agency added.
• The European Commission (EC), which generally follows the opinion of the CHMP, will make final decision on the approval of the drug.
• Ztalmy was approved in the U.S. in March 2022. and was commercially launched in July the same year.
• MRNS +3.97% to $7.31 premarket May 26

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