All articles tagged with #sage therapeutics
Originally Published 7 months ago — by Investor's Business Daily
Supernus Pharmaceuticals is acquiring Sage Therapeutics in a $561 million deal, boosting Sage's stock significantly amid recent setbacks and pipeline challenges, with the deal offering a premium over previous bids and potentially valuing Sage at up to $795 million if milestones are met.
Originally Published 7 months ago — by Sage Therapeutics
Supernus Pharmaceuticals is acquiring Sage Therapeutics in a deal valued at up to $795 million, aiming to expand its neuropsychiatry portfolio with the FDA-approved postpartum depression treatment ZURZUVAE and to achieve significant growth and cost synergies by 2026.
Originally Published 2 years ago — by CNN
The first oral pill approved by the FDA to treat postpartum depression, called Zurzuvae, is now available in the US. The medication, which costs $15,900 per course before insurance, has shown promising results in reducing depressive symptoms within three days. However, concerns have been raised about its accessibility due to the high cost. Biogen and Sage Therapeutics have launched a patient support program to provide financial assistance and medication at no cost for eligible individuals. Other options for treating postpartum depression, such as SSRIs, are more affordable but take longer to take effect.
Originally Published 2 years ago — by Endpoints News
Sage Therapeutics is laying off 40% of its workforce following the FDA's rejection of its major depressive disorder (MDD) drug. The company's pill was approved for postpartum depression but the rejection forced a reevaluation of their plans. Two key employees, including the chief scientific officer, are departing, and the company employed 689 people as of February 8th.
Originally Published 2 years ago — by Barron's
The split FDA decision on a new depression medicine from Sage Therapeutics and Biogen has disrupted the strategies of both companies and cast doubt on the future of their collaboration.
Originally Published 2 years ago — by MarketWatch
Sage Therapeutics' stock plummeted by 49% in premarket trading after the FDA approved its zuranolone treatment for postpartum depression but not for major depressive disorder (MDD). The FDA's approval makes zuranolone the first and only oral treatment for postpartum depression, a condition that affects one in eight new mothers in the US. Sage is currently reviewing the FDA's feedback and considering its next steps, including resource allocation and a workforce reorganization. CEO Barry Greene stated that the company plans to provide more details and next steps before the end of the third quarter. Biogen, which co-developed zuranolone, also saw a decline in its stock.
Originally Published 2 years ago — by CBS News
The FDA has approved zuranolone, the first oral treatment for postpartum depression. Branded as Zurzuvae, the once-a-day pill is meant to be taken for two weeks and has shown rapid improvement in depression symptoms. Postpartum depression affects an estimated 15% of women after childbirth and can last for months or even years. Previously, the only approved option was an IV infusion. Zuranolone works by rebalancing dysregulated neuronal networks in the brain. The drug carries a boxed warning for side effects such as drowsiness and dizziness, and a risk of suicidal thoughts. It will need to clear a 90-day DEA scheduling process before entering the market. The FDA only approved zuranolone for postpartum depression, not major depressive disorder, citing a lack of evidence.
Originally Published 2 years ago — by NPR
The FDA has approved the first pill, Zurzuvae, specifically designed to treat severe depression after childbirth. Postpartum depression affects thousands of new mothers in the U.S. each year, and while standard treatments like counseling or antidepressants may not work for everyone, Zurzuvae has shown promising results in clinical trials. The pill, taken once a day for 14 days, has been found to reduce signs of depression within a few days for many patients. The drug's milder side effects and oral administration make it a beneficial option for women experiencing extreme postpartum depression.
Originally Published 2 years ago — by BBC
The US Food and Drug Administration (FDA) has approved the first pill, zuranolone (sold as Zurzuvae), for the treatment of postpartum depression (PPD). Previously, PPD treatment was only available as an intravenous injection. Clinical trials showed that the pill significantly reduced depressive symptoms within three days, with effects lasting up to four weeks after the last dose. Common side effects include drowsiness, dizziness, and diarrhea. The medication can affect a person's ability to drive and perform hazardous activities, and patients are advised not to drive or operate heavy machinery for at least 12 hours after taking it. The manufacturers, Sage Therapeutics and Biogen, had also sought approval for the use of zuranolone in major depressive disorder (MDD), but the FDA determined that further studies were needed.
Originally Published 2 years ago — by Fox Business
The FDA has approved the first pill, called Zurzuvae, specifically for the treatment of severe postpartum depression. The drug, to be taken once a day for two weeks, has shown positive results in reducing depression symptoms in women. Postpartum depression affects around 400,000 women each year, and Zurzuvae provides a beneficial oral medication option for those coping with extreme feelings. However, concerns remain about the long-term effects and cost of the drug.