DIRS.INFO The most relevant business & tech news

REUTERS/Andrew Kelly/File PhotoAug 7 (Reuters) - The U.S. drug regulator's approval of Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) first-of-its-kind postpartum depression (PPD) pill is unlikely to allay the drugmakers' growth concerns, analysts said on Monday. Adverse commentary after their PPD drug was approved by the U.S. Food and Drug Administration (FDA) on Friday sent Sage shares tumbling 40%, while Biogen dropped 3% in premarket trading. Zurzuvae's use as a clinical depression treatment represents a more than $1 billion sales opportunity compared with $250 million to $500 million potential for postpartum depression, said Jefferies analyst Michael Yee. "Postpartum depression is not necessarily where a big commercial opportunity is," Biogen CEO Christopher Viehbacher said last month. The U.S. FDA said last week that additional studies might be required to support the drug's approval for major depressive disorder (MDD), or clinical depression.

Persons: Andrew Kelly, Sage, Biogen, Baird, Brian Skorney, Skorney, Zurzuvae, Jefferies, Michael Yee, Christopher Viehbacher, Yee, Mariam Sunny, Bhanvi, Manas Mishra, Vinay Dwivedi Organizations: Food and Drug Administration, FDA, REUTERS, Sage Therapeutics, U.S . Food, Drug Administration, U.S, Thomson Locations: White Oak , Maryland, U.S, Bengaluru

☆ Sage Therapeutics stock plunges more than 50% after FDA denies wider use of postpartum depression drug
▼ + stars: | 2023-08-07 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

In this photo illustration, the Sage Therapeutics logo of a biopharmaceutical company seen on a smartphone and on a pc screen. Shares of Sage Therapeutics fell more than 50% on Monday after the Food and Drug Administration approved the biotech company's oral drug zuranolone for postpartum depression, but not for major depressive disorder, a bigger potential market. The two companies also applied for approval of zuranolone for major depressive disorder, also known as clinical depression. Zuranolone had the potential for $1 billion in peak sales, compared with $250 million to $500 million for postpartum depression, Jefferies analyst Michael Yee said in a research note Sunday. He said clinical depression "was really the big upside driver here" for the companies, while postpartum depression is "much smaller and may not be hugely profitable."

Persons: Sage, Zuranolone, Jefferies, Michael Yee Organizations: Sage Therapeutics, Food and Drug Administration

A trader works on the floor of the New York Stock Exchange (NYSE) in New York City, U.S., July 26, 2023. U.S. stocks have sharply rallied in 2023, with the benchmark S&P 500 (.SPX) clocking 17% gains year to date, fueled by optimism around artificial intelligence and hopes of a soft landing for the world's largest economy. "But in the service side, it's been pretty sticky and that's one reason why it's taking a lot longer for inflation to subside." Reuters GraphicsOverall, second-quarter earnings have been better-than-expected so far, with 79.1% of the 422 S&P 500 companies that have reported as of Friday beating analysts' estimates, according to Refinitiv data. The S&P index recorded 17 new 52-week highs and seven new lows, while the Nasdaq recorded 46 new highs and 128 new lows.

Persons: Brendan McDermid, Dow, Charlie Ripley, it's, John Williams, Michelle Bowman, Vaibhav, Zachary Kirkhorn, Berkshire Hathaway, Warren Buffett, Tyson, packer, Bansari Mayur Kamdar, Johann M, Saumyadeb Chakrabarty, Maju Samuel Organizations: New York Stock Exchange, REUTERS, Berkshire, Tyson, Dow, Nasdaq, Federal, CPI, Allianz Investment Management, York Fed, Dow Jones, Apple, Reuters, Sage Therapeutics, Tyson Foods, Yellow Corp, NYSE, Thomson Locations: New York City, U.S, Bengaluru

☆ FDA approves oral pill for postpartum depression for first time
▼ + stars: | 2023-08-05 | by ( ) www.reuters.com time to read: +2 min

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo/File PhotoAug 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. The companies had sought the FDA's approval for the drug, Zurzuvae, to treat major depressive disorder (MDD), or clinical depression, as well as postpartum depression, which affect millions of people. Analysts have anticipated that the stocks of both companies would fall if the drug was approved only for postpartum depression, due to the smaller patient population. Until now, the FDA said, treatment for postpartum depression was available only as an intravenous injection.

Persons: Andrew Kelly, Zurzuvae, Biogen, Sage, Sriparna Roy, Lavanya, Krishna Chandra Eluri, Leslie Adler, William Mallard Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, Sage Therapeutics, U.S . Drug Enforcement Administration, Therapeutics, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru

☆ US FDA approves Biogen-Sage Therapeutics pill for postpartum depression
▼ + stars: | 2023-08-04 | by ( ) www.reuters.com time to read: +1 min

REUTERS/Andrew Kelly/File Photo/File PhotoAug 4 (Reuters) - The U.S. Food and Drug Administration on Friday approved Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) oral pill to treat postpartum depression (PPD) in adults. The companies had sought the FDA's approval for the drug, Zurzuvae, to treat major depressive disorder), or clinical depression, as well as postpartum depression (PPD), which affect millions of people. Analysts were anticipating the stocks of both companies to fall if the drug was approved only for postpartum depression due to the smaller patient population. Until now, the FDA said, treatment for postpartum depression was available only as an IV injection. Postpartum depression (PPD) affects around one in seven women who give birth.

Persons: Andrew Kelly, Sriparna Roy, Lavanya, Krishna Chandra Eluri, Leslie Adler Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, Sage Therapeutics, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru

☆ Oppenheimer says investors are missing opportunities in three biotech areas and the related stocks
▼ + stars: | 2023-05-16 | by ( Christina Cheddar Berk | ) www.cnbc.com time to read: +4 min

As biopharma investors follow the latest buzz around advancements in clinical research, they may be under-appreciating opportunities in neurology, psychiatry and genetic medicine, according to a report from Oppenheimer. "Valuation multiples across disease areas show CNS [ or central nervous system] and Genetic Medicine at relative low points." In July, the Food and Drug Administration could grant full approval to Leqembi , its Alzheimer's Disease treatment. As a very new area of medicine, gene therapy has greatest potential to accelerate sales growth as treatments come to market. He described immunology multiples as "generally stable" and genetic medicine multiples as highly volatile.

☆ The top doctor at a $2.7 billion pharma company developing a new depression drug says we may be 'on the cusp' of a new wave of mental-health treatments
▼ + stars: | 2023-02-13 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +6 min

Most depression treatments don't work quickly and are meant to be taken for long periods of time. Sage Therapeutics is developing a fast-acting drug that patients take for two weeks. That's according to Laura Gault, the chief medical officer at Sage Therapeutics, a Massachusetts-based company working to develop a new antidepressant drug, called zuranolone. Sage's stock has climbed 7.9% in the past 12 months, giving the company a market value of about $2.7 billion. Unlike most other antidepressants, zuranolone is designed to be taken for a short period of timeIn trials, zuranolone has improved symptoms of major depressive disorder and postpartum depression.

☆ Key inflation data in the week ahead will offer clues to future Fed rate moves and the market's path
▼ + stars: | 2023-02-11 | by ( Zev Fima | ) www.cnbc.com time to read: +8 min

Looking forward The January consumer price index (CPI) , which calculates the average change over time in prices that shoppers pay for goods and services, is slated for Tuesday. Economists and investors will use the number to gauge the odds of a soft landing or hard landing for the economy. The producer price index (PPI) for January, which calculates the change in selling prices received by producers of goods and services, is out on Thursday. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust's portfolio.

☆ Biogen's new CEO says Alzheimer's will become a major franchise for the company but that a different drug has the 'biggest undervalued potential'
▼ + stars: | 2023-01-09 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +4 min

But new CEO Christopher Viehbacher said that he sees Alzheimer's becoming a new franchise. He added that zuranolone, an antidepressant, is the "biggest undervalued potential" of the company. On the heels of the approval of a new Alzheimer's drug, Cambridge-based biotech company Biogen seems focused on expanding its focus to a wider range of illnesses. New Alzheimer's drug lecanemab could signal a new franchiseThe first is lecanemab, a drug for Alzheimer's disease that was granted an accelerated approval by the US Food and Drug Administration last week. "I think zuranolone is the biggest undervalued potential of Biogen," Viehbacher said.

☆ Health-care ETFs tend to rise around next week's annual JPMorgan conference. Here's what to know
▼ + stars: | 2023-01-06 | by ( Jesse Pound | ) www.cnbc.com time to read: +3 min

Next week is one of the biggest of the year for health-care investors, and it has historically been a good time to own ETFs that track the industry. The 2023 JPMorgan Health Care Conference is set to kick off next Monday in San Francisco. The sector's S & P 500 weight also sits at a 50-year high of 16%. According to a note from Goldman Sachs, health care is now the second-biggest weight in the S & P 500. Merck , Eli Lilly and AbbVie were a few of the stocks with the biggest positive contributions to the S & P 500 last year, according to Goldman.

☆ Insider buying: This CEO bought roughly $5 million of his stock after an activist investor lawsuit
▼ + stars: | 2022-11-18 | by ( Jesse Pound | ) www.cnbc.com time to read: +2 min

The CEO of medical device company Masimo bought roughly $5 million of stock over the past week, adding to his stake shortly after a lawsuit from an activist investor. Masimo : CEO Joe Kiani made two groups of purchases worth nearly $5 million in total on Nov. 11 and Nov. 14. Corebridge Financial : director Alan Colberg bought about $688,000 worth of stock on Nov. 10. Cogent Communications : director Marc Montagner bought roughly $549,000 of stock on Nov. 9. The purchase of Cogent stock by Montagner is the largest ever insider purchase for the internet service provider.

☆ Stocks making the biggest moves premarket: Target, Lowe's, Carnival and others
▼ + stars: | 2022-11-16 | by ( Peter Schacknow | ) www.cnbc.com time to read: +2 min

Lowe's (LOW) – Lowe's added 2.4% in premarket trading after the home improvement retailer beat top and bottom line estimates for its latest quarter and reported better-than-expected comparable store sales. Carnival (CCL) – Carnival slumped 12.7% in the premarket after the cruise line operator announced a $1 billion convertible debt offering as part of its refinancing plan. Advance Auto Parts (AAP) – Advance Auto Parts plummeted 14.7% in off-hours trading after the auto parts retailer posted lower-than-expected quarterly earnings. Competitor O'Reilly Auto Parts (ORLY) fell 2.9%. Sage Therapeutics (SAGE) – Sage Therapeutics gained 3.3% in premarket trading after an SEC filing showed CEO Barry Greene added 14,500 shares to his stake in the drug maker.

☆ Stocks making the biggest moves midday: Target, Carnival, Advance Auto Parts, Lowe's and more
▼ + stars: | 2022-11-16 | by ( Samantha Subin | ) www.cnbc.com time to read: +3 min

Advance Auto Parts — Advance Auto Parts tumbled 16.3% after reporting lower-than-expected quarterly earnings after the bell Tuesday. Lowe's said the company, unlike Target, is not seeing negative inflation impact on sales. O'Reilly Automotive — Shares automotive parts retailer added 2% after the company upped its share repurchase program by $1.5 billion. Oscar Health — The insurance stock added 1.9% after Wells Fargo upgraded the stock to overweight, saying shares can rally nearly 40% going forward. Lincoln National — Shares added 2.1% following an upgrade to a buy rating by Goldman Sachs.

☆ Stocks making the biggest moves after hours: Carnival, Advance Auto Parts and more
▼ + stars: | 2022-11-15 | by ( Samantha Subin | ) www.cnbc.com time to read: +1 min

In an aerial view, the Carnival Miracle cruise ship operated by Carnival Cruise Lines sits docked at Pier 27 on September 30, 2022 in San Francisco, California. Carnival announced a private offering of $1 billion in convertible senior notes due in 2027. Shares of rival cruise operators Royal Caribbean and Norwegian Cruise Line fell about 2% and 3.3%, respectively, on the news. Advance Auto Parts — Shares of the auto parts provider shed 9.9% after the company missed Wall Street's earning per shares estimates and lowered its adjusted EPS outlooks for the year. Ginkgo Bioworks — The stock — created during the SPAC boom — slipped 6.4% in extended trading after Gingko announced a $100 million common stock offering.

Search resuls for: "Sage Therapeutics"

14 mentions found