Brief: Mithra Announces Promising Topline Safety Results From Donesta Phase 3 Study In US

Mithra Pharmaceuticals SA

03/03/2023 22:08

March 3 (Reuters) - Mithra Pharmaceuticals SA
 MITRA.BR :
    * MITHRA ANNOUNCES PROMISING TOPLINE SAFETY RESULTS FROM
DONESTA®
PHASE 3 STUDY IN NORTH AMERICA
    * FULL DATASET ANALYSIS IS STILL IN PROGRESS
    * RESULTS WILL SUPPORT FILING WITH U.S. REGULATORY AGENCY
ANTICIPATED BY END OF H1 2023 FOR MARKET AUTHORIZATION IN H1
2024
    * PRIMARY SAFETY DATA ARE ANTICIPATED IN H1 2024 FOR EUROPE
WITH
MARKET AUTHORIZATION IN H1 2025
    * PHASE 3 NORTH AMERICAN STUDY TOPLINE SAFETY RESULTS
SUPPORT
OVERALL GOOD SAFETY PROFILE OF DONESTA
    * HIGHLIGHTS WILL BE PRESENTED DURING WEBCAST DEDICATED TO
MITHRA’S 2022 FULL YEAR RESULTS

Source text: [ID: https://bit.ly/3kGmdGW]
Further company coverage:  MITRA.BR 

 (Gdansk Newsroom)
 ((gdansk.newsroom@thomsonreuters.com; +48 58 7696600;))