Moberg Pharma AB announced that the Decentralized Procedure hasended with a positive outcome and that MOB-015 is recommended for national approval in 13 European countries for the treatment of mild to moderate fungal infections of the nails in adults. The approval in the European Union represents the first marketing authorizations for MOB-015's new onychomycosis treatment worldwide. Approval is supported by two Phase 3 trials where MOB-015 demonstrated superior levels of mycological cure (76% vs up to 42% for comparators), and a significantly better complete cure rate compared to vehicle, without any serious adverse reactions.

MOB-015 is a topical formulation of terbinafine, enabling effective concentrations of terbinafine to the nail and nail bed while avoiding the risk of systemic exposure seen with oral terbinafine use. The Decentralized Procedure includes the following EU countries: Austria, Belgium, Czech Republic, Denmark, Finland, France, Hungary, Ireland, Italy, Netherlands, Norway, Spain and Sweden. Next steps include national implementation in each country and granting of marketing authorizations including OTC-approvals when applicable.

National approvals are expected to follow during upcoming months and timelines may vary between countries.