European marketing authorization application for MOB-015 submitted

Rhea-AI Summary

Moberg Pharma AB has submitted a marketing authorization application for MOB-015, a new treatment for nail fungus, as of March 28, 2022. The application is part of a decentralized procedure in Europe, with market approval anticipated in 2023. By receiving this approval, Moberg aims for up to ten years of data exclusivity. The Swedish Medical Products Agency will lead the review process. CEO Anna Ljung emphasized the importance of this submission, highlighting the need for an effective treatment for nail infections.

Positive

• Application for MOB-015 submitted, indicating progress towards market entry.
• Potential for up to ten years of data exclusivity in Europe post-approval, enhancing competitive advantage.

Negative

• None.

STOCKHOLM, March 28, 2022 /PRNewswire/ -- 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 28^th, 2022.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/moberg-pharma/r/european-marketing-authorization-application-for-mob-015-submitted,c3529030

The following files are available for download:

https://mb.cision.com/Main/1662/3529030/1551387.pdf

European marketing authorization application for MOB-015 submitted

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SOURCE Moberg Pharma

FAQ

What is the marketing authorization application for MOB-015?

Moberg Pharma has submitted a marketing authorization application for MOB-015, a nail fungus treatment, expected to receive approval in 2023.

When was the MOB-015 application submitted?

The marketing authorization application for MOB-015 was submitted on March 28, 2022.

What is the expected outcome of the MOB-015 application?

The expected outcome is market approval for MOB-015 in Europe in 2023, allowing for potential data exclusivity.

Who is leading the review process for the MOB-015 application?

The Swedish Medical Products Agency is the reference member state leading the review of the MOB-015 application.