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    Moderna, Merck vaccine with Keytruda delays return of deadly skin cancer after 3 years, data says

    Moderna and Merck’s experimental cancer vaccine, when used in combination with Keytruda, reduced the risk of death or relapse in patients with the most deadly form of skin cancer after three years, according to midstage trial data.
    Those results build on midstage trial data the companies released earlier this year, which examined the efficacy of the combination over a shorter period.
    Moderna and Merck are also testing the vaccine with Keytruda against other tumor types, including non-small cell lung cancer.

    An exterior view of Moderna’s clinical manufacturing facility. 
    David L. Ryan | Boston Globe | Getty Images

    Moderna and Merck’s experimental cancer vaccine, when used in combination with Merck’s blockbuster therapy Keytruda, reduced the risk of death or relapse in patients with the most deadly form of skin cancer after three years, according to midstage trial data released Thursday. 
    The combination specifically slashed the risk of death or recurrence of the cancer, known as melanoma, by 49% in patients in later stages of the disease compared to those who received Keytruda alone after three years. The cancer vaccine in combination with Keytruda also reduced the risk of melanoma spreading to other parts of the body by 62%.

    Those results build on midstage trial data the companies released earlier this year, which showed the efficacy of the combination in the same 157 patients over a shorter period. After around two years, the vaccine and Keytruda cut the risk of death or relapse by 44% in melanoma patients, and reduced the risk of the cancer spreading in the body by 65%, according to the earlier trial data. 
    The most common side effects of the vaccine after three years were fatigue, injection site pain and chills, according to Thursday’s data.
    The new results suggest that the cancer shot used with the immunotherapy continues to provide meaningful health benefits to melanoma patients after they stay on the treatment for a longer period of time. The two drugmakers are continuing to study the combination as a treatment for melanoma in a late-stage trial, which began in July.
    The vaccine, which uses the same mRNA technology as Moderna’s Covid vaccine, is custom-built based on an analysis of a patient’s tumors after surgical removal. The shot is designed to train the immune system to recognize and attack specific mutations in cancer cells.
    Merck’s Keytruda, which is approved to treat melanoma and other cancers, belongs to a class of widely used immunotherapies known as checkpoint inhibitors designed to disable a certain protein that helps cancer evade the immune system.

    The U.S. Food and Drug Administration gave breakthrough therapy designation to the cancer vaccine for the treatment of melanoma in February, which is intended to speed up the development and review of treatments for serious and life-threatening diseases.
    Moderna and Merck are also testing the vaccine with Keytruda against other tumor types. On Monday, the drugmakers started a late-stage trial on the combination as a treatment for non-small cell lung cancer.
    Melanoma is responsible for the large majority of skin cancer deaths, according to the American Cancer Society. The rate of melanoma has increased rapidly over the past few decades, according to the organization.
    About 100,000 people will be diagnosed with melanoma in the U.S. this year and nearly 8,000 people are expected to die from the disease, according to the American Cancer Society.Don’t miss these stories from CNBC PRO: More

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    GM’s Cruise robotaxi unit dismisses nine ‘key leaders’ amid safety investigation

    General Motors’ Cruise autonomous vehicle unit has dismissed nine “key leaders” amid ongoing safety investigations.
    The shakeup, which was first reported by Reuters, follows an initial analysis of Cruise’s response to an Oct. 2 accident involving one of Cruise’s robotaxis.
    Cruise paused all roadway operations in the U.S. in late-October.

    A Cruise self-driving car, which is owned by General Motors, is seen outside the company’s headquarters in San Francisco.
    Heather Somerville | Reuters

    General Motors’ Cruise autonomous vehicle unit has dismissed nine “key leaders” amid ongoing safety investigations sparked by an October accident in San Francisco, according to an internal message obtained by CNBC.
    The departures include leaders from Cruise’s legal, government affairs, commercial operations and safety and systems teams, according to the company-wide message, which GM and Cruise spokespeople confirmed was authentic.

    The message said “new leadership is necessary” for the company to regain trust and operate “with the highest standards when it comes to safety, integrity, and accountability.”
    Cruise’s troubles are the latest for the self-driving vehicle industry. Commercializing autonomous vehicles has been far more challenging than many predicted even a few years ago. The challenges have led to a consolidation in the autonomous vehicle sector after years of enthusiasm touting the technology as the next multitrillion-dollar market for transportation companies.
    The shakeup at Cruise, which was first reported by Reuters, follows an initial analysis of the company’s response to an Oct. 2 accident involving one of Cruise’s robotaxis, which dragged a pedestrian after the person was struck by another vehicle.
    Following the accident, the California Department of Motor Vehicles suspended the deployment and testing permits for its autonomous vehicles in late-October. Cruise then followed up with pausing all roadway operations in the U.S.

    The company also faces regulatory pressure and fines for potentially misleading or withholding information about the accident. The National Highway Traffic Safety Administration and California Public Utilities Commission are probing Cruise and the incident.

    GM CEO Mary Barra, who serves as chair of Cruise, last week in Detroit said the company is “very focused on righting the ship” at Cruise. Its actions include two ongoing external safety reviews that will guide the company’s path forward. They are expected to be completed in early 2024, she said. 
    “The personnel decisions made today are a necessary step for Cruise to move forward as it focuses on accountability, trust and transparency. GM remains committed to supporting Cruise in these efforts,” GM said in an emailed statement Wednesday.
    The additional departures come roughly a month after Cruise CEO and co-founder Kyle Vogt and co-founder and Chief Product Officer Dan Kan both resigned.
    This is also a setback for an industry dependent on public trust and the cooperation of regulators. The unit had in recent months touted ambitious plans to expand to more cities, offering fully autonomous taxi rides.
    GM purchased Cruise in 2016. It then brought on investors such as Honda Motor, SoftBank Vision Fund, and, more recently, Walmart and Microsoft. However, last year, GM acquired SoftBank’s equity ownership stake for $2.1 billion.
    GM executives, including Barra, had hoped the startup would be ramping up a driverless transportation network this year, and hoped Cruise would play a notable role in doubling the company’s revenue by 2030.
    But thus far, Cruise has cost GM more than $8 billion since the company acquired it in 2016, according to public filings. The losses have been increasing annually, including $1.9 billion through the third quarter of this year.Don’t miss these stories from CNBC PRO: More

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    Vertex shares pop after nonopioid painkiller posts positive midstage trial results

    Shares of Vertex jumped after the company’s nonopioid painkiller significantly decreased pain in diabetes patients suffering from a chronic nerve condition in a midstage trial. 
    Those positive results support the biotech company’s hopes to develop a drug that can provide strong pain relief without the addictive potential of opioid medications.
    Vertex said it is “working with urgency” to advance the drug to a late-stage trial.

    A sign hangs in front of the world headquarters of Vertex Pharmaceuticals in Boston on Oct. 23, 2019.
    Brian Snyder | Reuters

    Shares of Vertex Pharmaceuticals jumped Wednesday after the company’s painkiller, which is being tested as an alternative to opioids, significantly decreased pain in a midstage trial.
    Those positive results for diabetes patients suffering from a chronic nerve condition support the biotech company’s hopes to develop a drug that can provide strong pain relief without the addictive potential of opioids. Plenty of other similar painkillers never reached the market.

    Analysts have said that the painkiller, called VX-548, could become a blockbuster drug if it wins approval from regulators, meaning its annual sales could exceed $1 billion.
    Vertex said in a release that it is “working with urgency” to advance the drug to a late-stage trial, which would bring it one step closer to winning approval from regulators. 
    Vertex is also testing the medication in closely watched late-stage studies for acute pain, with data due in the first quarter of next year. Acute pain is caused by injury, surgery, illness, trauma or painful medical procedures. 
    VX-548 has the potential to be a multibillion-dollar product for both acute pain and the chronic nerve pain in diabetes patients, Vertex executives said in a call Wednesday. 
    Vertex’s stock closed 13% higher following the release of the midstage trial data. Shares of the company are up nearly 40% this year and got a boost last week after U.S. regulators approved the first-ever gene-editing therapy for sickle cell disease from Vertex and its partner CRISPR Therapeutics. 

    The phase-two trial tested the drug over 12 weeks in roughly 160 patients with diabetic peripheral neuropathy, a long-term complication from diabetes that damages peripheral nerves, such as those in the arms and legs, due to high blood sugar levels. 
    The condition can cause mild to debilitating pain, numbness and, in more severe cases, issues with digestion, bladder and heart rate control. An estimated 50% of the roughly 40 million U.S. patients with diabetes have some peripheral neuropathy. 
    The trial specifically measured pain intensity using an 11-point scale, with 10 being the “worst pain imaginable.” High, mid and low doses of the drug reduced average pain intensity by 2.26, 2.11 and 2.18 points, respectively.
    The company said the drug was generally well-tolerated, and that the majority of adverse events were mild or moderate.
    The trial also followed a separate group of patients treated with pregabalin, a nonopioid therapy approved nearly two decades ago to block nerve pain and treat seizures. Pregabalin reduced average pain intensity by 2.09 points over 12 weeks. 
    JPMorgan analyst Jessica Fye said investors likely wanted to see Vertex’s painkiller show efficacy “at least on part” with pregabalin, noting that Wednesday’s results “clearly support that.”
    Fye also highlighted that patients appeared to have an easier time tolerating VX-548 compared to pregabalin in the trial. The rate of adverse events related to treatment with Vertex’s painkiller was lower than that of pregabalin, she noted.
    In a note Wednesday, Jefferies analyst Michael Yee wrote that the data overall “looks at least as good as or better than investor expectations.”Don’t miss these stories from CNBC PRO: More

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    Etsy stock falls after company lays off 11% of its staff, citing ‘very challenging’ environment

    Etsy is laying off 11% of its workforce, about 225 employees.
    Etsy CEO Josh Silverman noted in a letter to employees that Etsy’s marketplace has more than doubled in size since 2019 but said today’s macroenvironment and competitive realities call for sweeping changes. 
    The marketplace giant also updated its fourth-quarter guidance and is now expecting its adjusted EBITDA margin to be between 27% and 28%, up from previous guidance of 26% to 27%. 

    Etsy is laying off 11% of its workforce at the height of the holiday season as the e-commerce giant looks to restructure its business and streamline costs against a “very challenging” macro and competitive environment, the company announced Wednesday. 
    Approximately 225 employees will be cut from Etsy’s workforce, which will bring the headcount for the core Etsy marketplace to about 1,770 people, similar to the company’s headcount in early 2022 and above 2020 levels. 

    Etsy CEO Josh Silverman noted in a letter to employees that Etsy’s marketplace — known for selling handmade items and connecting buyers with local artisans across the globe — has more than doubled in size since 2019 but said today’s realities call for sweeping changes. 

    Josh Silverman, CEO of Etsy.
    Adam Jeffery | CNBC

    “We are operating in a very challenging macro and competitive environment, and [gross merchandise sales] has remained essentially flat since 2021,” the letter reads. “This means we are not bringing our sellers more sales, which is the single most important thing we can do for them. At the same time, employee expenses have grown, even as we have introduced significant cost-cutting measures and adjusted or paused hiring plans. This is ultimately not a sustainable trajectory and we must change it.”
    The news comes alongside updated fourth-quarter guidance for Etsy. The company now expects gross merchandise sales to decline between 1% and 2% during the period from the year-ago quarter and revenue to increase between 2% and 3%. It’s expecting adjusted EBITDA margin of between 27% and 28%, up from previous guidance of 26% to 27%. 
    Shares of Etsy closed 2% lower following the announcement, after falling as much as 7% earlier in the day.
    “Etsy is intensely focused on reigniting growth, driving sales for our nearly 7 million sellers around the world, and delivering value to all of our stakeholders. Today, we announced that we are reorganizing our internal structure so that we can double down on these efforts, which unfortunately means saying goodbye to approximately 225 of our colleagues,” Silverman said in a statement to CNBC. 

    The layoffs come two days after toymaker Hasbro announced it was cutting 1,100 employees as it grapples with soft sales that have continued into the crucial holiday shopping season. Hasbro had about 6,300 employees as of earlier this year, according to a company fact sheet.
    Etsy’s layoffs will cost between $25 million and $30 million, the bulk of which will be used for severance payments, employee benefits and other related costs, the company said in a securities filing. Over time, the restructuring is expected to “deliver meaningful operational efficiencies and cost savings and/or cost avoidance,” especially when it comes to salary costs and benefits.
    The restructuring is expected to be complete by the end of the first quarter of 2024. 
    As part of the restructuring, Etsy’s chief marketing officer Ryan Scott will be leaving the company and his position will be consolidated under the chief operating officer role, which is currently held by Raina Moskowitz, a former American Express executive. 
    Etsy’s chief human resources officer Kimaria Seymour will also be leaving the company and will be replaced by Toni Thompson, the company’s current vice president of global people and talent strategy. 
    Considering the layoffs come in the middle of the holiday season when many employees are shopping for gifts for their loved ones, Etsy said it would pay affected staff through at least Jan. 2, even though the last working day for most staff will be Wednesday. 
    They’ll receive severance of 16 weeks of base pay, plus one week for each full year of service, along with other benefits such as extended COBRA health insurance benefits and the ability to keep their company laptop.Don’t miss these stories from CNBC PRO: More

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    Pfizer shares fall as 2024 revenue and profit forecast disappoints

    Shares of Pfizer fell after the drugmaker forecast 2024 revenue and profit below Wall Street’s expectations.
    A continued slowdown in demand for the company’s Covid vaccine and treatment Paxlovid largely drove the weakness.
    Pfizer also raised the target of its sweeping cost-cutting plan by $500 million, bringing the total to $4 billion. 

    Shares of Pfizer fell Wednesday after the drugmaker forecast 2024 revenue and profit below Wall Street’s expectations, as it sees weak demand for its once-blockbuster Covid products. 
    Pfizer also raised the target of its sweeping cost-cutting plan by $500 million, bringing the anticipated total to $4 billion.

    The company expects 2024 revenue of $58.5 billion to $61.5 billion. Wall Street had anticipated sales of $63.17 billion, based on a survey of analysts by LSEG, formerly known as Refinitiv.  
    Pfizer’s forecast suggests revenue next year could fall or come in flat compared with 2023. The company expects revenue of $58 billion to $61 billion this year.
    Pfizer also said it anticipates $5 billion in 2024 revenue from its Covid vaccine and $3 billion in sales from its antiviral pill Paxlovid, for a total of $8 billion from Covid products. That’s far less than the $13.8 billion in combined 2024 sales analysts expected. 
    “While we do not expect Covid vaccination and infection rates to change materially in 2024 versus this year, we have set our Comirnaty and Paxlovid 2024 revenue expectations lower,” Pfizer CFO Dave Denton told investors during a call Wednesday, referring to the company’s Covid products.
    The pharmaceutical giant also forecast adjusted earnings in the range of $2.05 to $2.25 per share. Analysts had expected adjusted profit of $3.16, according to LSEG. 

    Notably, Pfizer expects a 40-cent per share hit from financing costs related to its $43 billion acquisition of cancer drug developer Seagen, which it plans to formally close Thursday. 
    Shares of Pfizer closed nearly 7% lower on Wednesday, after earlier hitting a 10-year-low following the release of the forecast.
    Pfizer’s stock has fallen nearly 50% this year and is trading below where it was at the start of the pandemic in early 2020. 
    Shares of Pfizer’s German Covid vaccine partner BioNTech closed 1% lower on Wednesday, while the stock of its rival Moderna closed flat.

    More CNBC health coverage

    After raking in billions of dollars from its Covid products, Pfizer has struggled to navigate a world beyond the pandemic and reassure investors about its growth potential. Pfizer is hoping to shift investor focus toward its record drug pipeline, which includes a handful of cancer drugs from Seagen. 
    The company expects Seagen’s products to contribute $3.1 billion to 2024 revenue. Pfizer previously said it anticipates Seagen will rake in $10 billion in revenue by the end of the decade. 
    Seagen is a leading developer of medicine called antibody-drug conjugates, or ADCs, which are designed to kill cancer cells and spare healthy ones. ADCs have become among the most desired cancer drugs, with Merck, Bristol Myers Squibb and AbbVie recently signing billion-dollar deals to access them. 
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    SpaceX valuation climbs to $180 billion

    The valuation of Elon Musk’s space and internet company SpaceX hit $180 billion based on an ongoing secondary share sale, CNBC confirmed Wednesday.
    The company is discussing an agreement with investors to sell stock from insiders in a purchase offer at $97 a share, according to a person familiar with the discussions.
    SpaceX’s latest valuation ranks it above the market value of top U.S. defense contractors as well as the most valuable U.S. telecommunications companies.

    SpaceX’s next-generation Starship spacecraft atop its powerful Super Heavy rocket is launched from the company’s Boca Chica launchpad on an uncrewed test flight, near Brownsville, Texas, on Nov. 18, 2023.
    Joe Skipper | Reuters

    The valuation of Elon Musk’s SpaceX hit $180 billion based on an ongoing secondary share sale, CNBC confirmed Wednesday.
    The company is discussing an agreement with investors to sell stock from insiders in a purchase offer at $97 a share, according to a person familiar with the discussions. The offer does not include raising new capital, as the purchase offer represents a secondary sale of existing shares and is expected to close in January.

    SpaceX typically performs these secondary rounds about twice a year, to give employees and other company shareholders a chance to sell stock. The latest valuation represents a 20% increase from SpaceX’s previous high of $150 billion, which the company hit through a July secondary sale at $81 a share.
    It has a near-monopoly on the U.S. satellite launch market, due to its workhorse Falcon rockets and the struggles of rivals to field operational rockets to compete. SpaceX’s Starlink satellite internet business is seen as a key economic driver for the company, with more than 5,000 satellites launched to date and a service boasting upward of two million subscribers. Its monstrous Starship vehicle continues to advance in flight tests, representing an attempt to create a next-generation reusable rocket of unprecedented scale and power.

    Sign up here to receive weekly editions of CNBC’s Investing in Space newsletter.

    The company is one of the most valuable private companies in the world, classifying it as a “centicorn” or “hectocorn” — a $1 billion unicorn, 100 times over.
    SpaceX’s latest valuation ranks the company above the market value of any of the top U.S. defense contractors — including Boeing (about $150 billion), Lockheed Martin (about $112 billion) and Northrop Grumman (about $73 billion) — as well as the most valuable U.S. telecommunications companies — such as Verizon (about $154 billion) or AT&T (about $115.9 billion), according to FactSet data on Wednesday.
    The company did not immediately respond to CNBC’s request for comment on the sale process. Bloomberg first reported SpaceX’s $97 a share pricing.

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    Washington sports teams Capitals, Wizards to move to new Virginia complex in 2028

    The NHL’s Washington Capitals and the NBA’s Washington Wizards are slated to move to Alexandria, Virginia.
    It’s part of a $2 billion entertainment complex effort led by the state of Virginia and Monumental Sports & Entertainment, which owns both pro teams.
    The complex is expected to open in late 2028, pending legislative approval.

    The National Hockey League’s Washington Capitals and the National Basketball Association’s Washington Wizards are slated to move to Alexandria, Virginia, as part of a $2 billion entertainment complex effort, the state’s Gov. Glenn Youngkin announced Wednesday.
    The development, about 8 miles south of Washington, D.C., will house the new global headquarters for Monumental Sports & Entertainment, which owns the Capitals and Wizards, as well as the new home arena for the teams. The 9 million square foot district will also feature mixed-use retail, hotel and conference spaces.

    Virginia Gov. Glenn Youngkin answers questions following the announcement of a new sports arena for the Washington Wizards NBA basketball team and Washington Capitals NHL hockey team, December 13, 2023 in Alexandria, Virginia. 
    Win Mcnamee | Getty Images News | Getty Images

    “This is the most visionary sports and entertainment development in the world. The Commonwealth will now be home to two professional sports teams, a new corporate headquarters, and over 30,000 new jobs — this is monumental,” Youngkin said in a statement. 
    Construction on the complex is slated to begin in 2025 and it is set to open in late 2028.
    The development is subject to legislative approval, the statement noted. Legislators will have to greenlight the creation of the complex in the next Virginia General Assembly session.

    In an aerial view, the site of a new sports arena for the Washington Wizards NBA basketball team and Washington Capitals NHL hockey team is seen on December 13, 2023 in Alexandria, Virginia.
    Win Mcnamee | Getty Images News | Getty Images

    The $2 billion investment will come from bond sales as well as a $403 million contribution from Monumental Sports & Entertainment.
    “We are committed to providing world-class fan experiences while continuously evolving our teams, deepening community ties, and solidifying our role as leaders at the forefront of sports and technology,” said Monumental chair and CEO Ted Leonsis in a separate statement.Don’t miss these stories from CNBC PRO: More

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    Mortgage refinance demand jumps 19% after rates hit lowest level since July

    Mortgage rates dropped again last week, prompting a 19% jump in refinance applications.
    Demand for mortgages to buy a home also increased, but at a much lower rate of 4%.
    Home prices are still high, and housing supply remains tight.

    An aerial view of existing homes near new homes under construction (UPPER R) in the Chatsworth neighborhood on September 08, 2023 in Los Angeles, California. 
    Mario Tama | Getty Images

    Homeowners looking to refinance are finding savings after mortgage rates dropped again last week.
    The average contract interest rate for 30-year fixed-rate mortgages with conforming loan balances ($726,200 or less) decreased to 7.07% from 7.17%, with points falling to 0.59 from 0.60 (including the origination fee) for loans with a 20% down payment, according to the Mortgage Bankers Association. That was the lowest level since July.

    “Mortgage rates dropped last week, as incoming data point to a slowing economy and support a pivot bythe Federal Reserve to begin cutting rates next year,” said Mike Fratantoni, MBA senior vice president and chief economist.
    As a result, applications to refinance a home loan increased 19% last week from the previous week, according to the Mortgage Bankers Association’s seasonally adjusted index. Refinance demand was 27% higher than the same week one year ago.
    “Borrowers who had seen rates near 8% earlier this fall are now seeing some lenders quote rates below 7%. Refinance volume picked up in response to this drop in rates, with a particularly notable increase for FHA and VA refinance applications,” Fratantoni added.
    Applications for a mortgage to purchase a home rose 4% for the week but were still 18% lower than the same week one year ago. Homebuyers today may be getting a break from lower mortgage rates, but there is still tough competition in a market with high prices and few homes for sale.
    Mortgage rates have not moved much this week, as economic data so far has come in aligned with expectations. That could change Wednesday, depending on the outcome of the latest Federal Reserve meeting and comments from Chair Jerome Powell. Markets expect the Fed to hold steady on its benchmark rate while anticipating cuts next year.

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