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Tag: Products/Services

  • Enbridge $1.4 Billion Project Aims to Boost Canadian Oil Flow to U.S. Refineries

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    Pipeline operator Enbridge ENB 0.51%increase; green up pointing triangle will push ahead with a $1.4 billion expansion of its core network to boost deliveries of Canadian heavy oil and reach key refining markets in the U.S. Midwest and Gulf Coast.

    The Canadian energy company said Friday it reached a final investment decision on the first phase of a project to optimize its Mainline network, which is forecast to add egress capacity from Canada that will support increased production in the country and connect with what it described as the best refining markets in North America.

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    Robb M. Stewart

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  • Chips Held Hostage in Trade War Start Flowing Again to Auto Suppliers

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    Nexperia microchips are leaving China again, easing a shortage of simple but ubiquitous parts that threatened to paralyze the auto industry.

    German automotive supplier Aumovio, which was recently spun out of tire giant Continental, said Friday that the Sino-Dutch company’s semiconductors and components containing them were on their way from China to Aumovio’s distribution hub in Hungary.

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    Stephen Wilmot

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  • German Industrial Production Rebounds Weakly Amid Tentative Hopes Over Outlook

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    Industrial production in Europe’s largest economy rebounded less than expected in September, amid hopes that the outlook could be changing for the sector ahead of large-scale government investment.

    Output rose 1.3% on month, Germany’s statistics agency Destatis said Thursday, offsetting some of the 3.7% decline in August. Economists polled by The Wall Street Journal expected a larger 2.5% uptick.

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    Ed Frankl

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  • Exclusive | White House to Announce Resumption of Auto Chip Shipments From China

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    The White House is set to announce that the Dutch semiconductor company that paused shipments weeks ago and risked upending global car production will resume sending chips under a framework agreement reached during talks between President Trump and Chinese leader Xi Jinping, people familiar with the plans said. 

    The new policy on the Dutch chips is part of a forthcoming document from the White House laying out the details of the U.S.-China trade deal signed this week, according to the people.

    Copyright ©2025 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

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    Ryan Felton

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  • China, Betting It Can Win a Trade War, Is Playing Hardball With Trump

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    In its trade standoff with Washington, Beijing thinks it has found America’s Achilles’ heel: President Trump’s fixation on the stock market.

    China’s leader, Xi Jinping, is betting that the U.S. economy can’t absorb a prolonged trade conflict with the world’s second-largest economy, according to people close to Beijing’s decision-making. China is holding a firm line because of its conviction, the people said, that an escalating trade war will tank markets, as it did in April after Trump announced his so-called Liberation Day tariffs, prompting Beijing to hit back.

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    Lingling Wei

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  • Trump Threatens Higher Tariffs on China Citing Restrictions on Rare-Earth Elements

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    President Trump threatened to raise tariffs and impose export controls on China and said there was “no reason” to meet with Chinese leader Xi Jinping after Beijing’s new restrictions on rare-earth materials marked an escalation in tensions between the countries.

    China this week announced new export restrictions on rare earth minerals, which are critical components of products from semiconductors to electric vehicles and jet fighters. China dominates processing capabilities for rare earth minerals, giving it leverage over the U.S. and other nations.

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    Gavin Bade

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  • Munich Airport Pauses Flights After Latest Europe Drone Sighting

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    Germany’s Munich Airport grounded flights overnight after several drone sightings, the latest in a string of interruptions in European airspace that have spurred NATO members to retune defenses. The airport reopened and flights resumed on Friday morning.

    Air traffic was suspended Thursday night after the drones were spotted, grounding 17 departing flights and affecting nearly 3,000 passengers, the airport said. Additionally, 15 incoming flights were diverted to other airports in Germany and Austria. 

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    Joyu Wang

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  • Are Cheerios and Quaker Oats safe to eat? Experts weigh in on new pesticide concerns. 

    Are Cheerios and Quaker Oats safe to eat? Experts weigh in on new pesticide concerns. 

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    Should you pass on that morning bowl of cereal or oatmeal?

    That’s what some people may be asking in light of a study released this week by the Environmental Working Group, a Washington, D.C.-based nonprofit focused on agricultural and chemical-safety laws in the U.S. The study looked at the prevalence of a pesticide called chlormequat in oat-based food products, including cereals like Cheerios and Quaker Oats. 

    The EWG said it found detectable levels of the chemical in 92% of nonorganic oat-based foods purchased in May 2023.

    “Studies in laboratory animals show that chlormequat can cause harm to the normal growth and development of the fetus and damage the reproductive system,” Olga Naidenko, vice president at the EWG, told MarketWatch. Those risks, the EWG report noted, can include reduced fertility. 

    It has not been proven that the substance affects humans in the same way the studies cited by the EWG found it does lab animals, and there are other studies that have found chlormequat had no effect on reproduction in pigs or mice, or any impact on fertilization rates in mice.

    The EWG is still advocating that concerned consumers buy organic oat products as an alternative, however. 

    “Certified organic oats are, by law, grown without synthetic pesticides,” Naidenko said. 

    Representatives for General Mills
    GIS,
    +1.28%
    ,
    the company that makes Cheerios, and PepsiCo
    PEP,
    -0.92%
    ,
    which owns Quaker Oats, didn’t immediately respond to a request for comment. 

    ‘Any family raising kids or thinking about starting a family should do whatever they can do to avoid chlormequat. It’s not a safe product.’


    — Charles Benbrook, a scientific consultant who focuses on pesticides

    The EWG’s recommendation to go organic was echoed by experts that MarketWatch contacted. 

    Charles Benbrook, a scientific consultant based in Washington state who focuses on pesticides, said he’s an oatmeal eater who chooses organic oatmeal “when I can get it.”

    Regarding chlormequat, Benbrook said, “It’s not a safe product.”

    “Any family raising kids or thinking about starting a family should do whatever they can do to avoid chlormequat,” he said.

    Melissa Furlong, an assistant professor of environmental health sciences at the University of Arizona, said it’s important to note that chlormequat is not the only pesticide that is found in oat-based cereals. There’s still much we need to learn about the health effects the substance might have on humans, she added.

    “That’s not to say it isn’t the worst [pesticide]. We don’t really know,” Furlong said. 

    Chlormequat has not been approved for use on food crops grown in the U.S., according to the EWG, but it can be found in oats and oat products from other countries. Under the Trump administration, the Environmental Protection Agency started allowing imports of such products into the U.S., the EWG noted, which is why chlormequat can be found in some cereals sold in this country.

    The EPA is considering approving chlormequat for use on crops grown in the U.S., according to the agency’s website. In a call for public comment on its proposed decision, the agency said, “Based on EPA’s human health risk assessment, there are no dietary, residential, or aggregate (i.e., combined dietary and residential exposures) risks of concern.”

    The EPA didn’t respond immediately to a request for comment.

    For her part, Furlong said that while she usually buys organic oat products, she isn’t rigid about it — and she might still buy the occasional box of Cheerios.

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  • Eurozone Industrial Production Unexpectedly Expands Amid Signs Recovery for Sector

    Eurozone Industrial Production Unexpectedly Expands Amid Signs Recovery for Sector

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    By Ed Frankl

    Eurozone manufacturing is showing signs of life again after industrial production jumped unexpectedly in December, further signaling that the recent slump in manufacturing in the bloc may be coming to a close.

    Total production rose on 2.6% on month in December, according to figures published Wednesday by European Union statistics…

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  • Disney, Fox and Warner Bros. team up to launch new sports streaming service

    Disney, Fox and Warner Bros. team up to launch new sports streaming service

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    Walt Disney Co.’s ESPN, Fox Corp. and Warner Bros. Discovery Inc. are teaming to create a joint sports streaming service.

    The as-yet unnamed service, which could be available as early as the fall and offer a sort of Hulu model for sports, comes amid an explosion in sports-streaming rights and audiences.

    The service would essentially be a skinny bundle of the companies’ linear channels, including ESPN, ESPN2, ESPNU, SECN, ACCN, ESPNEWS, ABC, Fox, FS1, FS2, BTN, TNT, TBS, truTV, as well as the ESPN+ streaming service.

    “The launch of this new streaming sports service is a significant moment for Disney
    DIS,
    +2.73%

    and ESPN, a major win for sports fans, and an important step forward for the media business,” Disney Chief Executive Bob Iger said in a statement late Tuesday. “This means the full suite of ESPN channels will be available to consumers alongside the sports programming of other industry leaders as part of a differentiated sports-centric service.”

    Added Warner Bros.
    WBD,

    CEO David Zaslav: “This new sports service exemplifies our ability as an industry to drive innovation and provide consumers with more choice, enjoyment and value and we’re thrilled to deliver it to sports fans.”

    Each company will own one-third of the platform, according to Disney, in a deal reminiscent of the original Hulu, which started off as a joint venture between ABC, Fox and NBCUniversal.

    The service will have a new brand with an independent management team, and will be available to bundle with Disney+, Hulu and Max subscriptions.

    “We’re pumped,” Fox
    FOX,
    +0.55%

    CEO Lachlan Murdoch said. “We believe the service will provide passionate fans outside of the traditional bundle an array of amazing sports content all in one place.”

    More details, including pricing, will be announced later.

    Prominently missing from the deal are Comcast Corp.
    CMCSA,
    -1.00%
    ,
    which owns NBCUniversal and its sports lineup that includes NFL football and the Olympics, and Paramount Global
    PARA,
    -0.21%
    ,
    which owns CBS — which carries the NFL and college football, among other sports.

    The new service will showcase thousands of high-profile sporting events and include all four major sports leagues — the NFL, NBA, MLB and NHL — as well as college football and basketball, golf, tennis, cycling, soccer and UFC.

    Shares of Disney were down 1% in extended trading Tuesday, while Fox shares jumped 6% and WBD gained 3%.

    Mike Murphy contributed to this report.

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  • Saudi Arabia Halts Oil Production Capacity Increase

    Saudi Arabia Halts Oil Production Capacity Increase

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    By Pierre Bertrand

    Saudi Arabian Oil Co., commonly known as Saudi Aramco, said that it has been ordered by the Saudi government to keep its oil production capacity at 12 million barrels a day.

    The oil and gas company said it received the instruction while it was working to increase production to 13 million barrels per day.

    “Aramco announces that it has received a directive from the Ministry of Energy to maintain its Maximum Sustainable Capacity (MSC) at 12 million barrels per day,” it said in a statement.

    Write to Pierre Bertrand at pierre.bertrand@wsj.com

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  • Denim pioneer Levi’s is rolling out ‘tech pants’ and other new offerings this year. But will retailers stock them?

    Denim pioneer Levi’s is rolling out ‘tech pants’ and other new offerings this year. But will retailers stock them?

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    With a rough 2023 in the rearview mirror, Levi Strauss & Co. this year is trying to tackle its problems with new pants.

    That includes pants with lighter-weight denim; pants for women that can be worn as high-rise or low-rise; and even nondenim pants that management, during Levi’s
    LEVI,
    +1.27%

    earnings call on Thursday, referred to as a “tech pant” for men with “moisture control and 360 mobility.” The company also plans to expand its offerings of Performance Cool pants intended to keep the wearer cool and dry on hotter days.

    But as those products roll out, the retailers that account for most of Levi’s sales are still cautious about packing their shelves with new apparel — even though Levi’s executives pointed to slightly better demand from clothing stores during the fourth quarter and holiday period. And as the denim pioneer cuts costs, brings in new leadership and tries to be a bigger e-commerce player, Wall Street will now be digging around for signs of a payoff.

    “Ultimately, the market will be looking for evidence new strategies can drive accelerated growth,” Stifel analyst Jim Duffy said in a research note on Thursday.

    “We continue to believe in brand vitality and opportunities for extension. With product reflective of new direction arriving in the marketplace across 2024, the proof will be in consumer response,” he continued.

    In an interview with MarketWatch on Friday, Duffy said he was optimistic about Levi’s standing as an established brand and stronger demand for its dresses, skirts and other women’s clothing items. But the more products a company rolls out, he suggested, the more it has to invest to make them work — and the more it needs to manage if sales falter.

    “The risk, as I see it, is that more categories means more SKUs and more product that is fashion rather than core basic styles, and more investment and inventory that, if it doesn’t translate to the marketplace, could result in higher markdowns,” he said, referring to the stock-keeping units by which retailers track inventory.

    Levi’s on Thursday said it would lay off between 10% and 15% of its global corporate staff in the first half of this year, a move intended to save $100 million in costs over that period. The layoffs are part of a two-year plan, called Project FUEL, intended to save money and strengthen the part of Levi’s business that sells directly to consumers via its own e-commerce network and its physical stores, as opposed to third-party retail operations.

    The layoff announcement arrived days ahead of Chief Executive Chip Berg’s departure from that role, with Michelle Gass taking over on Jan. 29. As the company tries to be bigger than men’s jeans, Gass, in Levi’s earnings release on Thursday, said she saw an opportunity to grow internationally, make Levi’s own online and bricks-and-mortar sales a greater priority, and turn the brand into a larger “denim apparel lifestyle business.”

    Levi’s shares fell after hours Thursday, after the company’s full-year profit forecast came in below expectations. The stock rebounded 1.3% on Friday but is still down 10.3% over the past 12 months.

    Still, Levi’s direct-to-consumer sales jumped 11% during the fourth quarter, and accounted for 42% of sales overall. Duffy said that the company has pushed deeper into its direct-sales business because it gives executives greater insight into what consumers want, as well as more control over how it markets and sells its clothing. Cutting out other retailers also widens margins on sales, he noted.

    Levi’s operating margins were higher in the fourth quarter. It also declared a dividend of 12 cents per share, payable in cash on Feb. 23.

    But sales in Levi’s wholesale segment — the sales it gets from retailers who buy Levi’s product, then sell it to consumers — fell 2%. Better results in the U.S. and Asia were offset by a drop in Europe, the company said.

    Retailers have spent the past two years trying to clear unwanted clothes from their stockrooms, and cutting prices in the process, after spiking inflation restricted many shoppers’ appetites to basics.

    As Gass prepares to take the reins, she sought to put a positive spin on retail-chain sentiment. “So net-net, overall, as a company, we’re exiting the year on a strong note,” Gass said on the earnings call. “And U.S. wholesale, we’re encouraged. But as it relates to that channel, we’re not declaring victory yet. There’s been a lot of volatility this past year, some in our control, some outside. And so we are taking a cautious approach as we look forward.”

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  • Boeing’s financials won’t be hurt by latest 737 Max issues, analysts say. The company’s size is one reason.

    Boeing’s financials won’t be hurt by latest 737 Max issues, analysts say. The company’s size is one reason.

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    Alaska Airlines, United Airlines and Turkish Airlines have all grounded their Boeing 737 Max 9 airplanes after part of one such jet tore away during an Alaska Airlines flight on Friday. But despite the potential safety risks for travelers and further damage to Boeing’s
    BA,
    -8.03%

    reputation, some Wall Street analysts, for now, have downplayed the financial impact for the jet maker.

    In part, they pointed to the company’s status as one of two major players in aircraft production — the other being Airbus
    EADSY,
    +3.52%
    .
    They also cited a tighter supply of available aircraft and limited near-term impact, at least while investigators try to figure out the cause of the incident.

    Those airlines and others took the action over the weekend after a panel on a jet blew out about 10 minutes into Alaska Airlines Flight 1282 at an altitude of about 16,000 feet.

    No one died in the incident. But the Federal Aviation Administration ordered the temporary grounding of certain Boeing 737 Max 9 aircraft. The order covered 171 planes.

    Shares of Boeing fell 8.2% as the stock weighed on the Dow Jones Industrial Average
    DJIA.

    Still, some Wall Street analysts on Monday said to buy the stock anyway. They said the latest difficulties with the aircraft — which follow the 2019 grounding of Max jets by many nations following two fatal crashes — were unlikely to have a big near-term financial impact.

    BofA analysts, in a research note dated Sunday, said that “at this point in time, due to the duopoly nature of the industry, we do not see this impacting orders for any of the 737 MAX variants. However, if the hits to the program do keep coming … at some point, the flying public may lose confidence in the 737 MAX which could ultimately impact sales.”

    The analysts said it wasn’t clear yet whether the blowout on Friday was due to an assembly mistake at Boeing, an improper installation from fuselage maker Spirit AeroSystems or oversight issues elsewhere. But they noted that the aircraft was relatively new, having been delivered on Oct. 31. And they said that “some scrutiny must be saved for regulators as well, as the FAA is ultimately responsible for certificating these aircraft before delivery.”

    Spirit AeroSystems’ stock
    SPR,
    -11.13%

    was down 11%.

    Analysts at William Blair also said they didn’t expect a big hit to Boeing’s financials.

    “While the Alaska Airlines door plug accident was terrifying, we do not believe that it will have a major financial impact, unless another incident occurs after the aircraft returns to service,” they said in a note on Monday.

    Analysts there estimated that over the past two months, the Max 9 made up less than one-fifth of Boeing’s total deliveries. They said those deliveries would only be “modestly impacted over the first quarter as it could take some time to determine the cause.”

    Of the 23 analyst ratings on Boeing’s stock tracked by FactSet, 18 are buy ratings or the equivalent.

    Read more: How Boeing’s latest 737 Max problem is hurting the Dow

    However, Morgan Stanley analyst Ravi Shanker said the 737 Max 9 issues will likely disrupt first-quarter results for United Airlines
    UAL,
    +2.78%

    and Alaska Air
    ALK,
    -0.21%
    .

    “This will hopefully be a situation resolved in days/weeks rather than months, but it will also serve as a reminder of how fragile airline capacity can be despite the overhang of capacity,” Shanker said in a Monday research note.

    United Airlines’ stock rose 2.4% on Monday, while Alaska Air’s dipped by 0.3%.

    Along with United Airlines, Alaska Airlines and Turkish Airlines, Copa Airlines and Aeromexico grounded about 40 Boeing 737 Max 9 planes, according to reports.

    According to Deutsche Bank analysts, the affected fleet accounts for 16.1% of Alaska Airlines flights and 6.6% of United flights, although United has more 737 Max 9 aircraft than Alaska.

    Other airlines with the plane in their fleet include Jet Airways of India with one plane, Jin Air of Korea with three, KLM Royal Dutch Airlines
    KLMR,

    with five and Korean Air Lines
    003490,
    -1.52%

    with nine, according to Planespotter.net.

    European regulators also grounded the 737 Max 9 for inspection.

    Some major airlines do not have any 737 Max 9s in their fleets, including American Airlines
    AAL,
    +7.21%
    ,
    Southwest Airlines
    LUV,
    -0.10%

    and Air Canada
    AC,
    +3.42%
    ,
    according to reports.

    Also read: Shares in Boeing slump, supplier Spirit AeroSystems tanks, after panel blows out

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  • Bluebird Bio Stock Is in Free Fall

    Bluebird Bio Stock Is in Free Fall

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    Two weeks ago, bluebird bio secured Food and Drug Administration approval for its gene therapy for sickle cell disease, a significant milestone for the roughly 100,000 people in the U.S. who suffer from the condition.

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  • AMD Stock Is More Expensive Than Nvidia. That Makes No Sense.

    AMD Stock Is More Expensive Than Nvidia. That Makes No Sense.

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    Advanced Micro Devices is on a roll this week, with its shares marching higher since the chip maker revealed ambitious plans to push into artificial intelligence. Investors looking to dive in best be warned: the stock now looks more expensive than Nvidia.

    Continue reading this article with a Barron’s subscription.

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  • AMD wins high praise for AI advancements as its stock soars 6%

    AMD wins high praise for AI advancements as its stock soars 6%

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    While Advanced Micro Devices Inc. shares didn’t enjoy a Wednesday bump during the company’s artificial-intelligence event, they were rallying sharply Thursday as analysts reflected on the chip maker’s presentation.

    Chief Executive Lisa Su and her team “put together one of the most impressive new product event/launches by our reckoning in the last decade, perhaps ever,” Rosenblatt Securities analyst Hans Mosesmann wrote in a note to clients.

    The launch of AMD’s
    AMD,
    +7.09%

    MI300X AI/graphics-processing-unit accelerator “was not just a speeds and feeds geek fest (it was that for sure, with AMD claiming superiority in AI inferencing), but an industry movement coalescing around the concept of ‘open’ sourced technologies are preferred (demanded really), to address the insanely fast/accelerating life-changing thing that AI has become,” Mosesmann continued.

    Opinion: AMD’s new products represent the first real threat to Nvidia’s AI dominance

    He was also impressed by the company’s talk of its software platform ROCm, which he thinks is catching up to Nvidia Corp.’s
    NVDA,
    +1.54%

    CUDA.

    “Of course, Nvidia is not going away, and we are quite sure will remain the dominant AI player for years to come but AMD we feel made the case yesterday that they will be an important AI innovator on a secular basis,” Mosesmann noted, as he kept his outperform rating and $200 target price on the stock.

    AMD shares were up 6% in Thursday morning trading.

    Baird’s Tristan Gerra was also impressed.

    “Rapidly unfolding hyperscaler engagements, highly competitive AI architecture specs, along with accelerated new product roadmap, bode well for share gains and continued acceleration in AI-related revenue for AMD beyond 2024, while faster-than-expected rate of adoption so far could potentially drive upside in the AI revenue outlook for 2024, in our view,” he wrote.

    Read: Nvidia and Microsoft CEOs say industrial companies will benefit most from AI. Here are stocks to put on your watch list.

    Gerra also sees the potential for “high-volume deployments,” thanks to the “significant software milestones” AMD is showing. He rates the stock at outperform with a $125 target price.

    TD Cowen’s Matthew Ramsay said that AMD’s event reinforced his belief that the company “is well positioned to meaningfully participate” in the large total addressable market for AI accelerators.

    The company called out Microsoft Corp.
    MSFT,
    -0.01%
    ,
    Meta Platforms Inc.
    META,
    +2.41%

    and Oracle Corp.
    ORCL,
    -0.08%

    as customers, announcements that were “strong” but not “surprising,” in Ramsay’s view.

    “We remain encouraged that AMD is making an impressive case (and is getting customer support) to provide adaptive computing solutions for both training and inference in increasingly large [generative-AI] infrastructure builds,” he wrote. “We believe this signifies a strong AI strategy of delivering a broad portfolio of [central processing unit], GPU, and [field-programmable gate array] assets, with open software that enables easily deployed AI workloads while leveraging the company’s existing partnerships to accelerate its AI ramps at-scale.”

    Ramsay has an outperform rating and $130 target price on AMD shares.

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  • Roche's Inavolisib Breast Cancer Drug Shows Promise in Late-Stage Study

    Roche's Inavolisib Breast Cancer Drug Shows Promise in Late-Stage Study

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    By Mauro Orru

    Roche Holding said its investigational treatment, inavolisib, showed promise in a late-stage study to treat patients with breast cancer.

    The Swiss pharmaceutical company said Tuesday that the phase 3 study met its primary endpoint of progression-free survival, showing that inavolisib, in combination with palbociclib and fulvestrant, delivered a statistically significant and clinically meaningful improvement compared to palbociclib and fulvestrant alone.

    While Roche acknowledged that overall survival data were immature at this stage, it said it had observed a clear positive trend. The inavolisib combination was well tolerated.

    The group said inavolisib is an investigational, oral targeted treatment with potential to provide durable disease control.

    Write to Mauro Orru at mauro.orru@wsj.com

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  • Pfizer gets FDA green light for new shot that can streamline teenagers’ vaccinations

    Pfizer gets FDA green light for new shot that can streamline teenagers’ vaccinations

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    Pfizer Inc.
    PFE,
    -1.73%

    said Friday that the U.S. Food and Drug Administration has approved the first five-in-one vaccine designed to protect teenagers and young adults against meningococcal disease. 

    The new Pfizer shot, Penbraya, protects against the five most common subgroups of meningococcal disease, a rare but serious and potentially fatal illness that most often affects babies and teenagers. 

    Penbraya “has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots,” Annaliesa Anderson, Pfizer senior vice president and head of vaccine research and development, said in a statement. 

    The U.S. Centers for Disease Control and Prevention currently recommends that all 11- to 12-year-olds get a meningococcal vaccine protecting against four of the subgroups — A, C, W and Y — and get a booster dose of the same vaccine type at age 16. Teenagers and young adults age 16 to 23 may also get a meningococcal B vaccine, the CDC says, particularly if they’re at increased risk due to other health conditions. 

    The complex vaccination schedule has weighed on uptake of the meningococcal shots, and the COVID-19 pandemic may have compounded the problem, as many families missed routine appointments when vaccinations were due, researchers say. Among teenagers who were born in 2008 — who were due for their routine adolescent vaccinations as the pandemic was raging in 2020 — uptake of meningococcal and other recommended vaccines declined, according to CDC research. Only about 60% of the 17-year-olds surveyed by the CDC last year had received both recommended doses of the ACWY vaccine, and fewer than 30% had received at least one dose of the meningococcal B vaccine. 

    The new Pfizer shot combines components of a meningococcal group B vaccine and an ACWY vaccine. 

    A CDC immunization advisory committee is set to meet Oct. 25 to discuss recommendations for the use of Penbraya in teenagers and young adults, Pfizer said. 

    The green light for Penbraya gives Pfizer the edge in its race with GSK
    GSK,
    +0.54%
    ,
    which is also working on a five-in-one meningococcal shot. GSK earlier this year released positive late-stage clinical-trial results for that vaccine. 

    The FDA approval of Pfizer’s shot caps a rocky week for the pharmaceutical giant, which late last Friday cut $9 billion from its full-year revenue guidance due to reduced COVID sales expectations and announced a cost-cutting program designed to deliver savings of at least $3.5 billion. Pfizer executives said on a call with analysts Monday that development of combination respiratory vaccines, such as those that provide COVID and flu protection in one shot, remains a focus for the company, in part because they can help boost vaccine uptake.

    Pfizer shares were down 1.7% Friday and have dropped 40% in the year to date, while the S&P 500
    SPX
    has gained 10%.

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  • Ardelyx wins long battle for FDA approval of kidney-disease treatment 

    Ardelyx wins long battle for FDA approval of kidney-disease treatment 

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    Ardelyx Inc.
    ARDX,
    -0.58%

    on Tuesday won its long fight for U.S. regulatory approval of a treatment designed to help patients with chronic kidney disease.

    The biopharma company said late Tuesday that the U.S. Food and Drug Administration approved tenapanor, marketed under the brand name Xphozah, for control of serum phosphorus in patients with chronic kidney disease on dialysis. A high level of phosphorus in the blood is often a sign of kidney damage and can lead to weak bones, joint pain, cardiovascular problems and other issues.    

    The approval concludes an extraordinary comeback for Xphozah. Ardelyx’s application for approval of the treatment was previously rejected by the FDA in July 2021, when the agency said the drug’s effect was “small and of unclear clinical significance.” To preserve cash, Ardelyx a few months later said it would cut its workforce by 65%, but it also pursued multiple appeals of the agency’s decision. An FDA advisory committee voted last November that the benefits of Xphozah outweigh its risks. The agency late last year ultimately granted Ardelyx’s appeal, and the company resubmitted its Xphozah application to the FDA in April. 

    More than 550,000 people in the U.S. have chronic kidney disease and are on maintenance dialysis. The vast majority of them have high phosphorus levels, also called hyperphosphatemia, according to Ardelyx. 

    High phosphorus levels “must be taken care of in these patients, and the current therapies are mostly insufficient in doing so,” Ardelyx CEO Mike Raab told MarketWatch. 

    Chronic kidney disease patients with high phosphorus levels have traditionally been treated with phosphate binders that can soak up phosphorus from food during digestion, but that approach can require patients to swallow a large number of pills. The Xphozah treatment requires two pills a day, “each the size of a Tic Tac,” Raab said. 

    The FDA approved Xphozah as add-on therapy in patients who can’t tolerate or have an inadequate response to phosphate binders, Ardelyx said in a release.

    Xphozah, which will be Ardelyx’s second U.S. product launch, should be available sometime in November, Raab said.

    Ardelyx will present updated data on Xphozah for hyperphosphatemia at an American Society of Nephrology meeting in early November, the company said in a release Monday. 

    Ardelyx shares jumped in late September after Japanese regulators approved tenapanor for hyperphosphatemia in adults with chronic kidney disease on dialysis. 

    Ardelyx shares fell 0.6% on Tuesday and have gained 21% in the year to date, while the S&P 500
    SPX
    has gained 13.9%. 

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  • Family Dollar recalls dozens of P&G, J&J, Colgate products in 23 states due to incorrect temperature storage

    Family Dollar recalls dozens of P&G, J&J, Colgate products in 23 states due to incorrect temperature storage

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    Family Dollar voluntarily recalled dozens of over-the-counter drugs, products and medical devices sold at its stores because they had been stored at improper temperatures, according to the Food and Drug Administration late Tuesday.

    On the FDA’s website, the regulator said products affected by the recall were stored “outside of labeled temperature requirements by Family Dollar and inadvertently shipped to certain stores on or around June 1, 2023 through September 21, 2023.”

    Brands affected by the recall include Procter & Gamble’s
    PG,
    +0.99%

    Crest, Vicks and Pepto Bismol; Colgate
    CL,
    +0.26%

    ; Johnson & Johnson Inc.’s
    JNJ,
    -0.11%

    Tylenol and Listerine; and Bayer’s
    BAYN,
    +3.04%

    Aleve, according to a list provided by the FDA.

    The items were sold at stores in Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Kansas, Louisiana, Mississippi, Montana, North Dakota, Nebraska, New Mexico, Nevada, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington and Wyoming, between June 1 and Oct. 4, the FDA said.

    Family Dollar was acquired by Dollar Tree Inc.
    DLTR,
    +3.26%

    in a deal that closed in July 2015.

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