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Tag: SAGE Therapeutics Inc

  • Sage Therapeutics inventory plunges greater than 50% after FDA denies wider use of postpartum melancholy drug

    On this photograph representation, the Sage Therapeutics emblem of a biopharmaceutical corporate observed on a smartphone and on a computer display screen.

    Pavlo Gonchar | SOPA Photographs | Lightrocket | Getty Photographs

    Stocks of Sage Therapeutics fell greater than 50% on Monday after the Meals and Drug Management licensed the biotech corporate’s oral drug zuranolone for postpartum melancholy, however no longer for primary depressive dysfunction, a larger possible marketplace.

    Stocks of Biogen, which collectively evolved the remedy with Sage, had been up modestly.

    The FDA’s approval past due Friday made zuranolone the primary oral remedy for postpartum melancholy, a not unusual complication that is affecting 1 in 8 ladies right through and after being pregnant and hinders their skill to serve as most often.

    The 2 firms additionally implemented for approval of zuranolone for primary depressive dysfunction, often referred to as scientific melancholy. However the FDA stated they didn’t supply sufficient proof of the drug’s effectiveness in treating the situation, which impacts a miles higher inhabitants of sufferers.

    Medical melancholy afflicts roughly 17.3 million American adults, or about 7% of the folk ages 18 and older, in a given yr.

    Zuranolone had the possibility of $1 billion in height gross sales, when put next with $250 million to $500 million for postpartum melancholy, Jefferies analyst Michael Yee stated in a analysis observe Sunday.

    He stated scientific melancholy “used to be in reality the massive upside driving force right here” for the corporations, whilst postpartum melancholy is “a lot smaller and might not be vastly winning.”

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    Wells Fargo analyst Mohit Bansal additionally stated the scientific melancholy marketplace contributed to 85% of the company’s long run gross sales estimates for zuranolone. However “there is usually a silver lining because the pricing energy is also upper” in postpartum melancholy, he wrote in a Sunday analysis observe. 

    Sage and Biogen have no longer disclosed zuranolone’s value for postpartum melancholy remedy.

    The FDA stated further research may well be required to give a boost to the drug’s popularity of scientific melancholy. 

    However Yee famous that Biogen is not going to “briefly transfer ahead on every other late-stage find out about” at the drug for scientific melancholy because the corporate is that specialize in saving prices and lately introduced layoffs.

  • Shares making the largest strikes noon: Goal, Carnival, Advance Auto Portions, Lowe’s and extra

    Pedestrians cross through a Goal retailer within the Tenleytown community of Washington, DC, on August 17, 2022.

    Mandel Ngan | AFP | Getty Photographs

    Take a look at the corporations making headlines in noon buying and selling.

    Goal – Stocks of the large field store tumbled greater than 13.1% after the corporate mentioned its benefit fell through round 50% in its fiscal 3rd quarter and lower its fourth-quarter outlook, after seeing gross sales gradual in past due October. “As we glance forward, we think the difficult setting to linger past the vacation season and into 2023,” its CFO mentioned on an income name. Different retail names akin to Macy’s, Hole and Nordstrom adopted Goal decrease.

    similar making an investment newsInsurance inventory Oscar Well being is a purchase and will soar just about 40%, Wells Fargo says in improve

    Carnival Cruise – Stocks of Carnival Cruise traces shed 13.7% after the cruise operator introduced it could be offering $1 billion in convertible debt as a part of its 2024 refinancing plan.

    Advance Auto Portions — Advance Auto Portions tumbled 15.1% after reporting lower-than-expected quarterly income after the bell Tuesday. The car portions dealer was once therefore downgraded through UBS, which mentioned the corporate’s steep unit losses recommend “it’s dropping shoppers at a speedy tempo.”

    TJX Corporations — Stocks won 4.1% after the corporate crowned income estimates for the former quarter and named a brand new leader monetary officer.

    Lowe’s Corporations – Stocks of the store won 3% after the corporate reported robust income for the 3rd quarter and stored its steering in position. Lowe’s mentioned the corporate, in contrast to Goal, is now not seeing unfavorable inflation have an effect on on gross sales.

    Eating place Manufacturers Global — Stocks of the Burger King mum or dad corporate popped 6.7% after the corporate introduced plans to rent former Domino’s Pizza CEO Patrick Doyle as government chair.

    O’Reilly Car — Stocks car portions store added 1.1% after the corporate upped its percentage repurchase program through $1.5 billion.

    Etsy – Etsy stocks slipped 4.5% after Evercore ISI put the inventory at the company’s checklist of tactical underperformers, although it maintained its “outperform” ranking on stocks. The company likes Etsy’s long-term possible however sees weak spot within the percentage value within the coming months

    Zoom Video — The video conferencing title dove 4.5% after Citi reduced its value goal at the inventory and maintained its promote ranking. The financial institution additionally lower estimates for the fourth quarter and monetary yr 2024.

    Oscar Well being — The insurance coverage inventory rose fairly upper after Wells Fargo upgraded the inventory to obese, pronouncing stocks can rally just about 40% going ahead. The financial institution mentioned the outlook for Oscar Well being seems to be “favorable” following its year-to-date underperformance.

    Alcon — Alcon’s inventory won 4.6% after the corporate posted a quarterly benefit that simply beat analyst expectancies.

    Lincoln Nationwide — Stocks added 3.6% following an improve to a purchase ranking through Goldman Sachs. The financial institution mentioned stocks may soar greater than 30% from Tuesday’s shut and that the insurance coverage title must get better from an oversized price that in the past impacted traders’ self assurance.

    Sage Therapeutics —The biotechnology corporate concerned with mind well being ended the consultation flat after emerging on information that CEO Barry Greene added 14,500 stocks to his stake, consistent with an SEC submitting.

    Corteva — Stocks slid 2% following a downgrade to impartial from purchase through UBS in what it known as a valuation name. However UBS upped the seed-and-crop product maker’s value goal to $73 in keeping with percentage from $70.

    — CNBC’s Tanaya Macheel, Alexander Harring, Carmen Reinicke and Michelle Fox contributed reporting

  • Shares making the most important strikes premarket: Goal, Lowe’s, Carnival and others

    Take a look at the firms making headlines earlier than the bell:

    Goal (TGT) – Goal plunged 13.5% within the premarket after lacking consensus estimates through 59 cents with quarterly income of $1.54 consistent with proportion. The store expects a drop in vacation season gross sales and lower its running margin forecast for the present quarter in part. Goal additionally stated it’ll release a cost-cutting plan designed to avoid wasting as much as $3 billion consistent with 12 months.

    Lowe’s (LOW) – Lowe’s added 2.4% in premarket buying and selling after the house development store beat best and final analysis estimates for its newest quarter and reported better-than-expected similar retailer gross sales.

    Carnival (CCL) – Carnival slumped 12.7% within the premarket after the cruise line operator introduced a $1 billion convertible debt providing as a part of its refinancing plan.

    Advance Auto Portions (AAP) – Advance Auto Portions plummeted 14.7% in off-hours buying and selling after the automobile portions store posted lower-than-expected quarterly income. Even supposing its earnings matched Side road forecasts, effects had been impacted through shoppers transferring to its inexpensive in-house manufacturers reasonably than dearer nationwide manufacturers. The corporate additionally decreased its full-year outlook. Competitor O’Reilly Auto Portions (ORLY) fell 2.9%.

    Sage Therapeutics (SAGE) – Sage Therapeutics won 3.3% in premarket buying and selling after an SEC submitting confirmed CEO Barry Greene added 14,500 stocks to his stake within the drug maker.

    Corteva (CTVA) – Corteva fell 1% within the premarket after UBS downgraded the seed and crop coverage merchandise corporate’s inventory to impartial from purchase in what the company says is a valuation name. But, UBS higher its value goal on Corteva’s inventory to $73 from $70 consistent with proportion.

    Alibaba (BABA), NetEase (NTES) – The China-based corporations are a few of the shares gaining floor following a Reuters file that U.S. regulators won “just right get entry to” to audits of Chinese language companies indexed within the U.S. Alibaba rose 1.8% whilst Netease jumped 3.6% in premarket motion.

    Etsy (ETSY) – The net crafts market used to be placed on Evercore’s “Tactical Underperform” listing, even because the company maintained an outperform ranking at the inventory. Evercore likes Etsy’s long-term outlook however foresees a 3-month pattern of slower acquire frequency and a shift in spending towards lower-priced pieces. Etsy slid 3.6% within the premarket.

  • Shares making the most important strikes after hours: Carnival, Advance Auto Portions and extra

    In an aerial view, the Carnival Miracle cruise send operated by means of Carnival Cruise Strains sits docked at Pier 27 on September 30, 2022 in San Francisco, California.

    Justin Sullivan | Getty Photographs

    Take a look at the firms making headlines after the bell: 

    Carnival — Stocks of the cruise line plummeted greater than 13% in prolonged buying and selling after the corporate introduced plans to boost extra debt. Carnival introduced a non-public providing of $1 billion in convertible senior notes due in 2027. Stocks of rival cruise operators Royal Caribbean and Norwegian Cruise Line fell about 2% and three.3%, respectively, at the information.

    Advance Auto Portions — Stocks of the automobile portions supplier shed 9.9% after the corporate overlooked Wall Boulevard’s incomes in step with stocks estimates and decreased its adjusted EPS outlooks for the yr. Income fell in step with analysts’ expectancies.

    Sage Therapeutics — Sage Therapeutics stocks added just about 8% in prolonged buying and selling on information that CEO Barry Greene upped his stake within the biopharma corporate, in line with SEC filings.

    Ginkgo Bioworks — The inventory — created right through the SPAC increase — slipped 6.4% in prolonged buying and selling after Gingko introduced a $100 million not unusual inventory providing.