Raphael Stevens

Gilead’s twice-yearly shot reduced HIV infections by 96% in a second large study, the company said.
The data sets the stage for likely FDA approval of lenacapavir for HIV prevention.
Shares rose 3% in premarket trading.

A pharmacist holds a vial of lenacapavir, the new HIV prevention injectable drug.
Nardus Engelbrecht | AP

Gilead’s twice-yearly shot reduced HIV infections by 96% in a second large study, the company said Thursday.
The positive phase-three trial data on lenacapavir sets the stage for likely approval by the U.S. Food and Drug Administration for HIV prevention.

“Now that we have a comprehensive dataset across multiple study populations, Gilead will work urgently with regulatory, government, public health and community partners to ensure that, if approved, we can deliver twice-yearly lenacapavir for PrEP worldwide, for all those who want or need PrEP,” said Gilead CEO Daniel O’Day in a statement.
PrEP or, pre-exposure prophylaxis, is medication taken to prevent getting HIV, according to the Centers for Disease Control and Prevention.
Gilead shares climbed more than 1% on Thursday.
The company said 99.9% of participants who received lenacapavir did not acquire HIV, with two cases among 2,180 people. The trial included cisgender men, transgender men, transgender women and gender non-binary people who have sex with partners assigned male at birth.
There were nine cases of HIV in a group of more than 1,000 people assigned to receive Truvada, Gilead’s older daily pill used for prevention and treatment. The company said lenacapavir was 89% more effective than Truvada in the study. 

Lenacapavir and Truvada were also “generally well-tolerated” by patients with no new safety concerns, according to Gilead. The drugmaker plans to present detailed data at an upcoming medical conference. 
Gilead in June also said lenacapavir was 100% effective at preventing HIV in another late-stage trial with cisgender women. None of the approximately 2,000 women in the study who received the shot had contracted HIV by the time of an interim analysis conducted in September 2023. 
In a research note Thursday, Jefferies analyst Michael Yee said overall the data on lenacapavir is “solid and consistent across both studies” and populations.
The trial results should lead to an FDA approval and launch in the market by 2025, Yee said. 
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Moderna said it plans to cut $1.1 billion in expenses by 2027 as it charts a path forward after the rapid decline of its Covid business. 
The biotech company said it expects 10 new product approvals through 2027.
But Moderna is also deprioritizing certain parts of its pipeline, which involves pausing work on some products and scrapping others.

Moderna headquarters, exterior view, Cambridge, Massachusetts, USA. 
Plexi Images | GHI | UCG | Universal Images Group | Getty Images

Moderna on Thursday said it plans to cut around $1.1 billion in expenses by 2027 and win approvals for several new products as it charts a path forward after the rapid decline of its Covid business. 
The biotech company said it expects 10 new product approvals through 2027. But Moderna said it will also pause work on some products in its pipeline and scrap others, as it aims to “pace ourselves” in new research and development spending. 

The company aims to trim R&D spending to a range of $3.6 billion to $3.8 billion in 2027, down from an expected $4.8 billion at the end of this year, according to a release.
“You’re going to start seeing things come down because there are some studies that we are going to basically sunset and we’re not going to start,” Moderna CEO Stephane Bancel told CNBC, adding that the company is putting its latent product portfolio “on hold.” That refers to a category of viruses that linger inside patients for prolonged periods without causing any symptoms but can reactivate and cause serious health complications later in their lives. 
Still, shares of Moderna fell more than 14% in premarket trading Thursday.
Leerink Partners analyst Mani Foroohar said in an email Thursday that the company’s updates “put to rest key elements of the bull thesis” for its stock and “reflect a worsening financial position.”
“R&D reductions are too far out chronologically to be credible from a management team that we think has proven serially unable to project the performance of their business,” Foroohar said.

In a research note Thursday, Jefferies analyst Michael Yee said that the bulk of the cost savings won’t be achieved until 2027, which “now delays profitability until 2028.”
Also on Thursday, Moderna announced positive late-stage trial results on its vaccine against respiratory syncytial virus in high-risk adults ages 18 to 59, with plans to file for approval for that age group this year. It also announced positive data on its experimental standalone flu shot for adults ages 65 and older. 
The company unveiled those updates during its annual research and development day investor event in New York on Thursday, which focuses on its product pipeline and long-term business updates. It comes around four months after U.S. regulators cleared Moderna’s RSV vaccine for seniors, its second commercially available product after its Covid vaccine. 
The company said it now has five respiratory shots with positive phase three results and expects to submit three of those jabs for approval this year. That includes Moderna’s combination shot targeting Covid and the flu, which it expects to file for approval in the U.S. this year, along with a new and more effective version of its Covid shot. 
Moderna also has five non-respiratory products across cancer, latent viruses and rare diseases that could be approved by 2027, according to the company’s release. 
The company expects 2025 revenue to come in at $2.5 billion to $3.5 billion. From 2026 to 2028, Moderna expects a compounded annual growth rate of more than 25% as new products launch. 
Bancel said the company’s rate of success for developing drugs from phase one to phase three is “six times higher” than the rest of the biotech and pharmaceutical industry. 
“That’s really a remarkable achievement that the team has accomplished, leaving us with a lot of drugs that are working, which is why need to pace ourselves in terms of R&D investment,” he told CNBC. 

What’s in Moderna’s pipeline?

Moderna presented new data on its RSV vaccine, mRESVIA, which is cleared in the U.S. and European Union for adults 60 and above. 
The company said the shot met all of the main efficacy goals in an ongoing phase three study on adults ages 18 to 59 who are at increased risk of getting severely sick from the virus. There were no safety concerns observed, Moderna added.
There are currently no RSV shots approved worldwide for younger, high-risk adults, such as those with weakened immune systems or underlying chronic conditions like asthma and diabetes. Moderna’s main rivals in the RSV space, Pfizer and GSK, are also seeking an expanded approval for the age group. 

Moderna CEO Stephane Bancel speaks at the grand opening of the company’s new headquarters outside Kendall Square.
David L. Ryan | Boston Globe | Getty Images

Bancel said the company plans to use a “priority review voucher” when it files for approval for people ages 18 to 59, which would reduce the amount of time it takes for the Food and Drug Administration to review the product to six months instead of 10 months. Moderna hopes the agency will clear mRESVIA for that age group in time for the RSV season in 2025. 
“It’s in the millions of people who could benefit … We are also doing so just to be competitive in the marketplace because if you are a large retail pharmacy, you want your product to be available for all of your customers that show up,” Bancel said. 
But the company is also discontinuing development of its RSV vaccine for infants under 2 years old based on “emerging clinical data.” 
Moderna said its experimental standalone flu vaccine, mRNA-1010, produced a higher immune response against the virus compared to an existing flu shot in a recent phase three trial. The shot has also demonstrated “consistently acceptable safety and tolerability” across three late-stage trials, the company added.
Meanwhile, Moderna said it plans to move its shot against norovirus, a highly contagious stomach bug that causes vomiting and diarrhea, to a phase three trial “imminently.” Bancel said he believes the company could finish the study within a year and file for approval immediately after if the data is positive. 
“This could be a product that is two years away from launch, which is great because there’s nothing today to treat norovirus,” he said. “A lot of healthcare professionals get infected by their patients.”
Moderna is also partnering with Merck to develop a personalized cancer vaccine, which is being studied in combination with Keytruda in patients with different forms of the disease. 
The companies are studying the shot in a phase three trial in patients with a deadly skin cancer and discussing an approval with regulators based on data from a mid-stage study on the jab.
But Moderna said the FDA has “not been supportive” of a so-called accelerated approval of the shot based on its existing data. That refers to an FDA designation that clears drugs faster if they fill an unmet medical need for serious conditions.
Bancel said “we’re going to keep having discussions” with regulators, and “we’re also generating more data.”
— CNBC’s Angelica Peebles contributed to this report More

Boeing and the union that represents some 33,000 workers unveiled a tentative agreement earlier this week.
The deal would include 25% raises over four years.
The current contract expires after midnight in Washington on Thursday.

A Boeing 737 MAX aircraft is assembled at the Boeing Renton Factory in Renton, Washington, on June 25, 2024.
Jennifer Buchanan | Afp | Getty Images

Boeing workers are voting on a new labor contract on Thursday, setting up the potential for a crippling strike if staff members decide to reject the deal just as the plane-maker is trying to ramp up its production.
The tentative agreement that the International Association of Machinists and Aerospace Workers and the company unveiled on Sunday included 25% wage increases and other improvements to health-care and retirement benefits. Boeing also committed to build its next aircraft in the Seattle area.

The vote is the first major test for CEO Kelly Ortberg, who said in a staff note on Wednesday that he has talked with employees about the contract in Renton, Washington, and Everett, Washington, where Boeing’s main factories are located.
Ortberg is just over one month into his role in the manufacturer’s top job, and has been tasked with steadying production and stamping out safety lapses and quality flaws in the wake of a door-panel blowout at the start of the year.
“I know the reaction to our tentative agreement with the IAM has been passionate,” he wrote in his staff note. “I understand and respect that passion, but I ask you not to sacrifice the opportunity to secure our future together, because of the frustrations of the past.”
The union, which represents about 33,000 Boeing factory workers in the Seattle area and in Oregon had sought some 40% pay raises from Boeing. But the 25% increase would be in line with the United Auto Workers’ deal last year that followed strikes at Ford, General Motors and Chrysler-parent Stellantis.
If approved, the Boeing deal would follow a series of union-negotiated pay increases across industries ranging from Hollywood to airlines.

“We have achieved everything we could in bargaining, short of a strike,” IAM District 751 district president Jon Holden wrote to members on Monday. “We recommended acceptance because we can’t guarantee we can achieve more in a strike. But that is your decision to make and is a decision that we will protect and support, no matter what.”

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Top pay for IAM workers at Boeing would rise to $57.43 an hour as soon as the new contract goes into effect. Including some cost-of-living adjustments, increases could rise by more than 42%, according to the union. Boeing said average annual machinist pay is currently $75,608, which would rise to $106,350 at the end of the four-year contract.
If the deal is rejected and two-thirds of workers vote in favor of a strike, a work stoppage would begin after midnight in Washington on Friday. If less than two-thirds vote to strike after the contract is rejected, the contract would automatically go into effect, the union said.
“For Boeing, it is no secret that our business is in a difficult period, in part due to our own mistakes in the past,” Ortberg said in his note. “Working together, I know that we can get back on track, but a strike would put our shared recovery in jeopardy, further eroding trust with our customers and hurting our ability to determine our future together.”
Polls are set to close at 6 p.m. PT.

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The head of Ford’s highly profitable “Pro” commercial and fleet business will retire at the end of this month, the company said Thursday.
The automaker said Ford Pro CEO Ted Cannis will be replaced on an interim basis by Andrew Frick, president of Ford’s traditional “Blue” operations.

Ted Cannis, chief executive officer of Ford Pro, speaks during an interview in New York, on Thursday, July 28, 2022.
Victor J. Blue | Bloomberg | Getty Images

DETROIT — The head of Ford Motor’s highly profitable “Pro” commercial and fleet business will retire at the end of this month, the company said Thursday.
The automaker said Ford Pro CEO Ted Cannis, who has spent 35 years with the company, will be replaced on an interim basis by Andrew Frick, president of Ford’s traditional “Blue” operations, until the company announces a new leader.

“Ted’s energy and passion for customers has been instrumental in building Ford Pro into a business that’s tracking towards $70 billion in revenue this year – a Fortune 100-size company in its own right,” Ford CEO Jim Farley said in a statement.
Ford Pro has been a profit-driver for the automaker. It has raked in about $18.7 billion in adjusted earnings and $184.5 billion in revenue since 2021, assisting in offsetting losses of its electric vehicles business.
Such results led Wall Street to praise the business, as analysts have called it a “hidden gem” and Ford’s “Ferrari,” referring to the highly profitable Italian sports car manufacturer.

Cannis also led Ford Customer Service Division, which handles global parts, services, accessories and vehicle customization for Ford dealers and customers worldwide.
Daniel Justo, who currently serves as chief financial office of Ford Blue, will begin overseeing the operations upon Cannis’ retirement.
“It’s been the most thrilling and rewarding chapter of my career to lead Ford Pro and FCSD,” Cannis said in a release. “Ford Pro is a profitably growing business with unmatched scale, talent, and the best dealers and upfitters – all to serve the people and businesses who keep our economy and communities humming. I can’t wait to watch Ford Pro and FCSD continue to innovate and grow.” More

SpaceX pulled off its first private spacewalk.
Two members of the Polaris Dawn mission’s crew — Jared Isaacman and Sarah Gillis — stepped outside of SpaceX’s Dragon capsule, protected from the harsh environment of space by the company’s suits.
Isaacman and Gillis spent about seven minutes each outside the capsule, with a focus on testing the mobility of the spacesuits.

Polaris Dawn commander Jared Isaacman emerges from SpaceX’s Dragon capsule during a spacewalk on Sept. 12, 2024.

SpaceX pulled off its first spacewalk in the early hours of Thursday morning, in a historic first for a company.
The marquee event of the private Polaris Dawn mission went smoothly, with two of the crew members — Jared Isaacman and Sarah Gillis — stepping outside of SpaceX’s Dragon capsule “Resilience.” It’s the first time civilians, and not government astronauts, have performed a spacewalk.

“Back at home we all have a lot of work to do but from here, Earth sure looks like a perfect world,” Isaacman, the mission’s benefactor and commander, said after emerging from the spacecraft.
The spacewalk, otherwise known as an extravehicular activity, or EVA, is seen by SpaceX as a crucial milestone in its goal of sending people to other planets.
SpaceX spent more than two years developing suits that can protect astronauts while in the harsh environment of space alongside the Polaris Program run by Isaacman, the billionaire founder of payments company Shift4. The mission is also the first to fly employees of the company, represented by mission specialist Gillis and medical officer Anna Menon.

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The Polaris Dawn event took about two hours in total, with the full crew of four exposed to the vacuum of space after the spacecraft’s hatch opened. Isaacman and Gillis spent about seven minutes each outside the capsule, with a focus on testing the mobility of the spacesuits.
SpaceX launched the mission on Tuesday. In addition to the spacewalk, Polaris Dawn reached an orbit of more than 1,400 kilometers from Earth — the furthest humans have traveled in space since the Apollo program — and is performing about 40 science and research experiments, as well as raising funds for St. Jude Children’s Research Hospital.

The Polaris Dawn crew, from left: Anna Menon, Scott Poteet, Jared Isaacman, and Sarah Gillis.

Isaacman, who first traveled to space leading the Inspiration4 mission in 2021, is leading the Polaris Program in an effort to push the boundaries of private spaceflight.
“This is the inspiration side of it … anything that’s different than what we’ve seen over the last 20 or 30 years is what gets people excited, thinking: ‘Well if this is what I’m seeing today, I wonder what tomorrow’s gonna look like or a year after,'” Isaacman told CNBC before the mission. More

Former NBA player Junior Bridgeman is set to buy a 10% stake in the Milwaukee Bucks, three sources familiar with the deal said.
Bridgeman, the current owner of Ebony and Jet Magazines, is getting a preferred limited partner discount to buy a portion of the team that he played for from 1975 to 1984, the sources said.
The deal values the team at $4 billion.

Ulysses “Junior“ Bridgeman attends Day 2 of 2023 Invest Fest at Georgia World Congress Center on August 27, 2023 in Atlanta, Georgia. 
Paras Griffin | Getty Images

Businessman and former NBA player Ulysses Lee “Junior” Bridgeman is buying a 10% stake in the Milwaukee Bucks, according to three sources familiar with the deal. The transaction will value the team at $4 billion.
NBA owners will be notified of the sale in a memo Thursday, added the sources, who asked to remain anonymous because the details of the deal are not public.

Bridgeman, the current owner of Ebony and Jet magazines, is getting a preferred limited partner discount of 15%, or a $3.4 billion valuation, to buy a portion of the team that he played for from 1975 to 1984, the sources said.
He is reported to have a net worth of more than $600 million after finding success in a variety of businesses ranging from fast-food chains to being a Coca-Cola bottling distributor.
Bridgeman and the Bucks did not immediately respond for comment.

Junior Bridgeman #2 of the Milwaukee Bucks looks to make a play against the Boston Celtics during a game played in 1984 at the Boston Garden in Boston, Massachusetts.
Dick Raphael | National Basketball Association | Getty Images

The Milwaukee Bucks are owned by Jimmy and Dee Haslam, Wes Edens, and Jamie Dinan. The three ownership groups each have about a 25% stake in the team.
This would mark the first NBA sale since the league signed an 11-year media agreement with Disney, Comcast’s NBCUniversal and Amazon Prime in July.

The deal shows the Bucks, a small-market team, are continuing to grow. When former Milwaukee Bucks co-owner Marc Lasry sold his 25% stake in the team to the Haslams last April, the team was valued at about $3.2 billion.
The team, which finished third last season in the NBA Eastern Conference, is losing money because it paid a reported $52 million luxury tax last season. The Bucks will likely pay a hefty luxury tax this season as they are paying Giannis Antetokounmpo $48 million, Damian Lillard $45 million and Khris Middleton $31 million for the 2024-2025 season.
The Bucks have two won NBA championships, in 1971 and 2021.
Disclosure: NBCUniversal is the parent company of CNBC.

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McDonald’s will extend its $5 value meal into December in most U.S. markets.
Franchisees have been voting on extending the value meal in their local markets, and roughly 80% of local markets have opted to extend the deal into December. 
The restaurant sector focused on value this summer, as companies including McDonald’s, Burger King and even Starbucks attempted to lure consumers in with discounted offerings as diners cut back on restaurant spending.

McDonald’s will extend its $5 value meal into December in most U.S. markets as it looks to win back lower-income consumers.
Franchisees have been voting on extending the value meal, and roughly 80% of local markets have opted to extend the deal into December. Votes on extensions are ongoing, so additional locations may be added in the weeks to come.

The value meal offers a McDouble or McChicken sandwich, small fries, four-piece chicken nuggets and a small soft drink for $5.
Owners will also be offering local promotions in the weeks and months to come, in addition to the value bundle, the company said. Deals will also be available in McDonald’s app.
“Together with our franchisees, we’re committed to keeping our prices as affordable as possible, which is why we’re doubling down with even more ways to save,” McDonald’s U.S. President Joe Erlinger said in a statement about the meal’s extension into December.

A McDonald’s McDouble cheeseburger, small fries, four-piece chicken nuggets, and a small soft drink arranged in New York, US, on Monday, June 17, 2024. 
Lucia Buricelli | Bloomberg | Getty Images

The restaurant sector focused on value this summer, as companies including McDonald’s, Burger King and even Starbucks attempted to lure consumers in with discounted offerings. Diners have pulled back on their restaurant spending after years of persistent inflation.
After McDonald’s posted declining second-quarter same-store sales in July, executives told restaurant operators and analysts the company would focus on how to recapture consumers with deals, as they pushed for an extension of the $5 value meal. The offer ran through the end of August, after 93% of restaurants had agreed to keep it on the menu following its initial four-week run in June and July.

In a memo to the U.S. system obtained by CNBC after the July earnings report, Erlinger said McDonald’s struggled to sell diners on affordability in the most recent quarter, adding that he expects “industry and competitive challenges” to continue throughout the year. Erlinger encouraged operators to look ahead to building momentum for next year, adding that “channeling a long-term mindset is crucial” to the company’s success. 
“Reversing the narrative and re-establishing our position as the leader on value and affordability is possible, but it cannot be done overnight,” he wrote at the time. “It will happen through sustained and coordinated actions that show the customer we’re on their side.”
The $5 meal trial performed well among low-income consumers, and sentiment around the company’s value had started to improve, Erlinger said in the July memo. More