|Bid||154.67 x 900|
|Ask||155.41 x 800|
|Day's Range||153.81 - 157.28|
|52 Week Range||79.88 - 188.82|
|Beta (3Y Monthly)||3.04|
|PE Ratio (TTM)||N/A|
|Earnings Date||Jul 30, 2018 - Aug 3, 2018|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||200.00|
, which just received FDA approval for Zulresso, the first treatment for postpartum depression. Dr. Jonas said that postpartum depression is the most common complication for women after childbirth, and suicide remains a leading cause of death among adults overall.
Shares of Sage Therapeutics Inc. rose 3% Wednesday morning after the company’s announcement Tuesday evening that the Food and Drug Administration had approved its drug for the treatment of postpartum depression.
Today was shaping up to be a bone-crushing session on Wall Street, Jim Cramer told his Mad Money viewers Wednesday. Without one, it will be a lot harder to own sectors like the industrials that need a strong global economy. Cramer explained that President Trump is taking a page from the Ronald Reagan playbook with Russia, "trust, but verify." The Chinese have a long history of not abiding by what they agree to, he said, which was evident most recently in the South China Sea.
Sage Therapeutics stock dipped Wednesday after the FDA approved its postpartum depression treatment, Zulresso. Investors are now looking at another depression drug called SAGE-217.
Sage said the FDA approved its Zulresso — chemically brexanolone — an injection for the treatment of postpartum depression. Zulresso has both Priority Review status as well as a Breakthrough Therapy Designation from the FDA. "The potential to rapidly reduce symptoms in this critical disorder is an exciting milestone in women's mental health," said Samantha Meltzer, the primary investigator of the Zulresso clinical trials.
Sage Therapeutics (NYSE:SAGE) is popped yesterday on FDA approval of its postpartum depression drug -- the first of its kind. So far, SAGE stock is up 3%, but this on the back of a more than 70% run up year-to-date in anticipation of the news.Source: Shutterstock Postpartum depression is a sometimes life-threatening condition that can happen before or after a woman gives birth to a child. In serious cases, she may harm herself or her child as a result. It is estimated that as many as one in nine women who have recently given birth suffer from postpartum depression, but it is a little talked about condition, so up to half of cases go unreported. But now there is a specific treatment. Zulresso was approved as an IV treatment to be administered in a certified healthcare facility over 2.5 days. With no other drug on the market to treat postpartum depression, Sage has no competition to worry about. And with a market cap of $7.8 billion -- lower than the addressable market potential for this treatment -- biotech investors cannot afford to ignore SAGE stock. Efficacy of ZulressoIn two clinical studies where participants received Zulresso or placebo, those who were treated showed an improvement of depressive symptoms compared to the placebo group.InvestorPlace - Stock Market News, Stock Advice & Trading TipsSage Therapeutics recently raised $500 million through a SAGE stock offering on February 25. This cash infusion will give the company the capital it needs to roll out Zulresso following its approval. Sage Is Sitting on Plenty of CashIn its fourth quarter, SAGE lost $3.38 per share on revenue of just $0.28 million. But it ended the period with $922.8 million in cash, cash equivalents and marketable securities. This is up from $518.8 million at the end of 2017. Sage's management said it has enough cash on hand to fund expenses until the second half of next year (2020).Sage accelerated its R&D activity, which increased such expenses to $88.8 million, up from $50.9 million. IT spent $282.1 million in R&D for the full year 2018. Sage spent more on discovery efforts associated with identifying new clinical candidates, along with additional indications in its three CNS franchises. After the FDA approved Zulresso, R&D costs associated with Phase 3 clinical development may shift to marketing and G&A spend instead. Ahead of the launch, Sage spent $201.4 million in G&A costs, up sharply from $62.9 million last year. Sage's Full PipelineWithin Sage Therapetics' pipeline are more promising drugs. For example, SAGE-217 is being tested for efficacy in treating major depressive disorder, postpartum depression, biopolar depression and insomnia. Meanwhile, SAGE-324 has an indication for Parkinson's Disease, Essential Tremor and Epileptiform Disorders. The Bottom Line on Sage StockEven after Sage stock's recent rally, 10 analysts who follow the stock have an average12-month target price of $198 -- according to Tipranks. That's more than 25% upside. Biotech investors who are looking for similar stocks could consider Neurocrine Bio (NASDAQ:NBIX) or Zogenix (NASDAQ:ZGNX). * 5 Cloud Stocks to Help Your Portfolio Fly Sage Therapeutics has a promising drug that will not face any competition. Markets already expect strong sales for Zulresso. The company has a strong cash balance and plenty of more drugs in the pipeline. For these reasons, biotech investors should take a serious look at SAGE stock.Disclosure: As of this writing, the author did not hold a position in any of the aforementioned securities. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 7 Invincible Stocks Leading The Bull Market Higher * 5 Dow Jones Stocks Coming to Life * 7 of the Best High-Yield Funds for 2019 and Beyond Compare Brokers The post Sage Stock Pops on FDA Approval for Postpartum Depression Drug appeared first on InvestorPlace.
FedEx led Wednesday's early declines, while Dow Jones stock Walt Disney edged higher, as stocks opened lower ahead of the Federal Reserve announcement.
Sage Therapeutics Inc. — which had its first medicine, Zulresso, a treatment for postpartum depression, approved late Tuesday — hopes to break the solo launch curse and translate its approval into sustained share price gains. Zulresso has a big advantage that a number of other troubled solo launches have lacked: It’s the first drug to be approved specifically for post-partum depression and works quickly after a single infusion. Most depression drugs take weeks to have an impact.
U.S. stock futures were down slightly on Wednesday, as investors awaited a key decision on interest rates and bond sales from the Federal Reserve and reacted to reports of potential tension in U.S.-China trade talks. Contracts tied to the Dow Jones Industrial Average fell 17 points, futures for the S&P 500 slipped 1.75 points, and Nasdaq futures were down 4.75 points. The Fed is expected to announce its decision on rates at 2 p.m. ET, with Fed Chairman Jerome Powell scheduled to lead a press briefing afterward.
Postpartum depression is a type of mood disorder that affects some women after childbirth, causing sadness and loss of interest in activities. Doctors have prescribed general antidepressants such as Zoloft to treat postpartum depression, but they can take several weeks to have an effect, and they don’t work for everyone. This is the second new depression drug the Food and Drug Administration has approved in March after decades that saw no major new treatments.
TRENTON, N.J. (AP) — The U.S. Food and Drug Administration has approved the first drug specifically developed for severe depression after childbirth.
The U.S. Food and Drug Administration on Tuesday approved https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633919.htm Sage Therapeutics Inc's drug for postpartum depression, marking the first approval of a treatment specifically developed for the condition that affects a new mother's ability to care for herself or her baby. The drug, which is administered as a single 60-hour intravenous infusion, is chemically identical to the hormone allopregnanolone. "You're talking about someone coming into the hospital or treatment center on a Friday and go home Sunday night," Sage's Chief Executive Officer Jeff Jonas told Reuters ahead of the approval.
Postpartum depression is the most common medical complication of childbirth, estimated to affect approximately 400,000 women annually in the U.S. Sage Therapeutics (SAGE), a biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, announced today the U.S. Food and Drug Administration (FDA) has approved ZULRESSOTM (brexanolone) injection for the treatment of postpartum depression (PPD). ZULRESSO is expected to be available in late June following scheduling by the U.S. Drug Enforcement Administration, which is expected to occur within 90 days.
The U.S. Food and Drug Administration has approved the first drug specifically developed for severe depression after childbirth.
rose 4% in after-hours trading Tuesday after the FDA approved its drug treatment for postpartum depression, a common complication of childbirth. The drug, Brexanalone, is the first from the biotech company to win approval from the FDA. Pospartum depression is a major depressive episode that occurs following childbirth, the agency said in a press release.
Zulresso is an IV injection used to treat the sometimes life-threatening condition of postpartum depression, which is a major depressive episode that occurs following or leading up to childbirth.
Zulresso is Sage's first product to reach the market and one of two treatments the company has developed to treat postpartum depression.
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Recent activity in depression treatment from Johnson & Johnson and Allergan could benefit Sage Therapeutics, an analyst said Thursday. Sage is working on an oral drug called SAGE-217.
Jim Cramer talks with Sage Therapeutics CEO Jeff Jonas about the biopharma company's Zulresso drug for postpartum depression and how it could help mothers.