Sage Therapeutics and Biogen Announce Plans to Submit a New Drug Application (NDA) for Zuranolone to the U.S. Food & Drug Administration in the Second Half of 2022 with Rolling Submission Expected to Start in Early 2022
Following the pre-NDA meeting, the companies confirmed t he current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD The planned initial submission package will be for the treatment of MDD with an anticipated PPD filing thereafter
Biogen Announces Topline Results from the Tofersen Phase 3 Study and its Open-Label Extension in SOD1-ALS
In the Phase 3 VALOR study, the primary endpoint as measured by the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) did not reach statistical significance; however, signs of reduced disease progression across multiple secondary and exploratory endpoints were observed The
Sustainability Report: 2020 Year in Review
Learn more about what actions we are taking to deliver on our bold and unwavering commitments to our patients, employees, environment and communities.