Although Sage Therapeutics, Inc.’s Phase III WATERFALL trial of zuranolone in adults with major depressive disorder (MDD) was positive, the benefit seen and its adverse event profile have raised doubts about its clinical meaningfulness, even if the data are sufficient to warrant US Food and Drug Administration filing.
Biogen/Sage’s Zuranolone Data May Not Be Enough For Tough Commercial Landscape
Phase III Data Seen As Underwhelming
The drug may have enough efficacy for approval, but data fell short of the benchmark seen as necessary for commercial adoption.
More from Business
• By
Aldeyra’s dry eye candidate reproxalap received a second FDA complete response letter, but the firm expressed confidence about refiling quickly based on two ongoing studies.
• By
Deal Snapshot: Lilly is the third company to sign a licensing deal for STAC-BBB with Sangamo, which also aims to secure a deal for its Fabry disease program in the second quarter.
• By
The challenging US biosimilar market remains a persistent problem, leading the biosimilar developer to reconsider how it invests in the future while pushing for changes.
• By
Public Company Edition: Stock valuations are falling due to political, economic and regulatory uncertainty, resulting in fewer large public offerings, more alternative financings and cost cuts. Carisma, Tenaya, BioAtla, Arbutus, Nkarta, Alector and Adaptimmune announced layoffs.