Sage Therapeutics Announces Second Quarter 2024 Financial Results and Highlights Pipeline and Business Progress
FDA approval was based on the results of 2 multicenter, randomized, double-blind, placebo-controlled studies (study 1 [NCT04442503] and study 2 [NCT02978326]) evaluating the efficacy of zuranolone for the treatment of women with PPD.2,3
Sage Therapeutics and Biogen may not have the broad label that they had hoped for with Zurzuvae, but the two companies are still touting the med’s initial launch performance in postpartum depression (PPD).
ZURZUVAE, the first and only oral, once-daily, 14-day treatment course, has shown to provide rapid improvements in depressive symptoms at Day 15 and as early as Day 3 for women with PPD Patient...
Before Sage and Biogen’s Zurzuvae (zuranolone) won approval from the FDA for postpartum depression (PPD) in August, the companies had said that the highly anticipated first-in-class treatment would be available for less than $10,000.
The Food and Drug Administration’s decision last month not to approve a new treatment for one of the most common forms of depression was, in part, due to safety concerns, according to newly released documents detailing the agency’s review process.
Sage Therapeutics is laying off 40% of its workforce this quarter in the wake of the FDA’s rejection of the biotech’s major depressive disorder drug earlier this month.
Shares of Sage Therapeutics are worth less than half of what they were late last week, after an approval decision for the company’s most closely watched medicine sharply limited its potential market.
Aug 4 (Reuters) - The U.S. Food and Drug Administration (FDA) on Friday approved Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) oral pill to treat postpartum depression (PPD) in adults.
MANHASSET, N.Y.--(BUSINESS WIRE)--Approximately one in eight women experience perinatal or postpartum depression (PPD) and current treatment options can take months for new mothers to find symptom relief, if ever. Today, The Feinstein Institutes for Medical Research at Northwell Health announced the publication of the results from the SKYLARK Study, a phase 3 placebo-controlled clinical trial of an investigational oral, 14-day neuroactive steroid zuranolone (50mg) pill in the treatment of PPD. The results showed rapid, clinically meaningful improvements in depressive symptoms at measured time points –supporting the potential for U.S. Food and Drug Administration (FDA) approval of the first oral, at-home, neuroactive steroid therapy to treat PPD.