zuranolone

Mixed-bag approval hit Sage hard but spared Biogen Sage Therapeutics recently notched an FDA win for the neuroactive steroid zuranolone (Zurzavae) for postpartum depression (PPD). For major depressive disorder (MDD), however, the agency handed the drug a complete response letter. In the wake of the news, Sage’s stock is down 46% to $19.52, while BIIB,…

FDA’s approval of Zurzuvae for PPD could mark a significant shift in the fight against postpartum depression (PPD). On August 4, the agency gave the green light for the oral medication, although it declined its use for major depressive disorder (MDD), citing insufficient evidence of effectiveness. The former approval represents a milestone as the first ever…

Biogen (Nasdaq:BIIB) and Sage Therapeutics (Nasdaq:SAGE) have announced that the FDA accepted the New Drug Application (NDA) for zuranolone, a neuroactive steroid. The drug candidate could be a novel 14-day oral medication to treat Major Depressive Disorders (MDD) or postpartum depression (PPD). Priority review has been granted and the application is slated to be processed…

Sage Therapeutics (Nasdaq:SAGE) and Biogen (Nasdaq:BIIB) have filed a rolling NDA submission to the FDA for zuranolone, a potentially novel, rapid-acting, daily treatment for adults with major depressive disorder (MDD) and postpartum depression (PPD).  If approved, zuranolone could significantly alter the antidepressant market. A neuroactive steroid, the drug would be prescribed as a 14-day oral…

Antidepressants remain some of the most widely prescribed drugs, but most popular antidepressants are now available as generics. While selective serotonin reuptake inhibitors (SSRIs) and SNRIs (serotonin and norepinephrine reuptake inhibitors) remain the most commonly prescribed antidepressants, various new types of drugs may be available in the future. For example, drug companies are working on…

Postpartum depression is one of the most common psychological conditions after childbirth, affecting roughly one in eight new mothers. “Postpartum depression is one of the most common — often underdiagnosed complications of childbirth,” said Dr. Samantha E. Meltzer-Brody, director of the University of North Carolina Center for Women’s Mood Disorders. The pandemic has likely only…

Sage Therapeutics (Nasdaq:SAGE) and Biogen (Nasdaq: BIIB) have begun a rolling submission of a New Drug Application (NDA) to FDA for zuranolone to treat major depressive disorder (MDD). The two companies plan on submitting additional clinical data for the NDA in the second half of the year. Biogen entered into a $1.5 billion licensing agreement…

Sage Therapeutics’ (NSDQ:SAGE) and Biogen’s (NSDQ:BIIB) experimental depression drug zuranolone fared well in a Phase 3 clinical trial comparing it to placebo in the treatment of postpartum depression. The investigational drug demonstrated meaningful improvements in terms of the baseline 17-item Hamilton Rating Scale for Depression (HAMD-17) score, the most common clinician-administered depression assessment scoring system.…

Biogen (NSDQ:BIIB) has entered into a licensing agreement with Sage Therapeutics (NSDQ:SAGE) to commercialize zuranolone (SAGE-217) and SAGE-324.  It will pay $1.5 billion in addition to potential milestone payments.  Zuranolone is an investigational neuroactive steroid that could treat major depressive disorder, postpartum depression, insomnia and other psychiatric disorders.  SAGE-324 could potentially treat essential tremor and…