European marketing authorization application for MOB-015 submitted
Moberg Pharma AB (publ) have submitted its marketing authorization application for MOB-015 (nail fungus treatment). The company has submitted the application in Europe through the decentralized procedure, and market approval is expected in 2023.
Moberg Pharma have submitted a full application, which offers the possibility of data exclusivity in Europe for up to ten years following market approval. The Swedish Medical Products Agency is the reference member state and will lead the review of the application. The company's goal is to receive its first market approval and launch MOB-015 in 2023.
“Submitting the Marketing Authorization Application in Europe is a key milestone in our journey to launch a new and improved nail fungus drug. MOB-015 is uniquely positioned through its high antifungal efficacy, since there is significant need for a treatment that truly cures the nail infection,” says Anna Ljung, CEO of Moberg Pharma AB.
For additional information, please contact:
Anna Ljung, CEO, telephone: +46 707 66 60 30, e-mail: anna.ljung@mobergpharma.se
About this information
This information is information that Moberg Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 8.00 a.m. CET on March 28th, 2022.
About Moberg Pharma, www.mobergpharma.se
Moberg Pharma AB (publ) is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The company’s main asset, MOB-015, is a novel topical treatment for onychomycosis. Data from phase 3 clinical trials in more than 800 patients for MOB-015 indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners in place in Europe and Japan, among others, and the company's goal is to receive its first market approval and launch MOB-015 in 2023. Moberg Pharma is headquartered in Stockholm and the company’s shares are listed on the Small Cap list of the Nasdaq Stockholm (OMX: MOB).