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    Gilead’s twice-yearly shot to prevent HIV succeeds in late-stage trial

    Gilead’s twice-yearly medicine to prevent HIV succeeded in a Phase 3 trial.
    None of the roughly 2,000 women in the trial who received the lenacapavir shot contracted HIV.
    Gilead needs to replicate the results in another Phase 3 trial before seeking FDA approval. The company expects to share more data later this year or early next year.
    If the results are positive, lenacapavir for PrEP could reach the market as soon as late 2025.

    The logo of Gilead Sciences pharmaceutical company is seen in Oceanside, California, April 29, 2020.
    Mike Blake | Reuters

    Gilead’s experimental twice-yearly medicine to prevent HIV was 100% effective in a late-stage trial, the company said Thursday.
    None of the roughly 2,000 women in the trial who received the lenacapavir shot had contracted HIV by an interim analysis, prompting the independent data monitoring committee to recommend Gilead unblind the Phase 3 trial and offer the treatment to everyone in the study. Other participants had received standard daily pills.

    The results bring Gilead one step closer to introducing a new form of pre-exposure prophylaxis, or PrEP, and broadening its HIV business. Shares of the company rose about 7% on Thursday. 
    “What the world needs is people to have more PrEP options so they can make the choice of the option that’s going to work best for them,” said Jared Baeten, Gilead’s vice president of clinical development for HIV. 
    Before seeking approval from the Food and Drug Administration, Gilead will first need to replicate these results. The company expects to share data later this year or early next year from an ongoing Phase 3 study of men who have sex with men. If those results are positive, the company could bring lenacapavir for PrEP to market as soon as late 2025.
    More than a decade ago, Gilead’s Truvada became the first approved PrEP for people without HIV who are at high risk of acquiring it. Daily pills dominate the market, but drugmakers are now focusing on developing longer-acting shots.
    PrEP slashes the risk of getting HIV from sex by 99%, and from injected drug use by 74% when taken correctly. Yet only a little more than one-third of people in the U.S. who could benefit from PrEP take it, according to data from the Centers for Disease Control and Prevention.

    Health policymakers and advocates hope longer-acting options could reach people who can’t or don’t want to take a daily pill and better prevent the spread of a virus that caused about 1 million new infections globally in 2022. 
    “It’s really important to have more options than daily pills because the orals aren’t going to get us to the end of the epidemic,” said Bruce Richman, founding executive director of the nonprofit Prevention Access Campaign. “We need to make sure that people have options to fit with their lifestyles.”
    The FDA approved the first injectable PrEP in 2021. That drug, Apretude, is given every other month, or six times a year, by a medical professional. About 11,000 people take Apretude, according to its manufacturer, ViiV.
    Tim Oliver, a 28-year-old public health worker in New York, said he doesn’t mind going to the doctor for his Apretude shots. But he added that some of his friends have told him they’d rather keep taking a daily pill than get an injection. A longer-acting option could be more attractive to patients.
    RBC Capital Markets analyst Brian Abrahams expects Gilead’s shot will significantly increase the number of people interested in preventive HIV medicine. He estimates peak sales of nearly $2 billion. Gilead’s newer PrEP pill, Descovy, notched about $2 billion of revenue last year. 
    Activists have urged Gilead to ensure that people in countries where low- and middle-incomes predominate can get access to lenacapavir. The company has long faced criticism over the price of its HIV medicines. Descovy usage carries a list price of $26,000 a year.
    In its statement disclosing the lenacapavir trial results Thursday, Gilead said it plans to share an update on how it plans to address access in such countries where people suffer high incidence rates of HIV. — CNBC’s Leanne Miller contributed to this report.

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    More states expected to roll out Inflation Reduction Act energy-efficiency rebates this summer

    New York was the first state to launch a rebate program for consumers tied to home energy efficiency upgrades.
    Many more states are expected to roll out similar Inflation Reduction Act programs this summer.
    Low-income New Yorkers can get up to $24,000 in combined state and federal funding.

    New York Gov. Kathy Hochul.
    Lev Radin/Anadolu Agency via Getty Images

    New York is launching a program offering homeowners up to $14,000 in total rebates for energy-efficiency upgrades to their property, and more states are expected to follow suit by summer’s end.
    The rebate programs are part of the federal Inflation Reduction Act, the largest piece of climate legislation in U.S. history, which President Joe Biden signed in 2022.

    The law earmarked $8.8 billion for consumers via two Home Energy Rebates programs.
    The financial incentives help consumers reduce or fully offset the cost of upgrades to make their homes more energy-efficient, thereby reducing carbon emissions and cutting homeowners’ future energy bills, state and federal officials said.
    Such projects might include installing air sealing, insulation, electric heat pumps and electric stoves, for example.
    More from Personal Finance:Here’s how to buy renewable energy from your electric utilityWhat the SEC vote on climate disclosures means for investorsHere’s why FEMA has spent about $4 billion to help destroy flood-prone homes
    New York launched part of its rebate program on May 30, making up to $14,000 of federal funds available to low-income households.

    When combined with a fledgling state program called EmPower+ — which offers up to $10,000 per low-income household — consumers can access up to $24,000 in total rebates for making energy-efficiency upgrades, according to Doreen Harris, president and CEO of the New York State Energy Research and Development Authority.

    ‘Several’ states will roll out rebates by September

    States, territories and tribes — which administer the programs — must apply for the federal funds.
    Seventeen states had applied for Home Energy Rebates funding as of June 14, according to the U.S. Energy Department. New York was the first to roll out funding to consumers.
    The Energy Department expects “several more states” to make the rebates available “between now and September,” it said. The agency has approved applications submitted by California and Hawaii, the final stage before rollout.
    New York’s launch “is a milestone,” said Kara Saul Rinaldi, CEO and founder of AnnDyl Policy Group, a consulting firm focused on climate and energy policy. “Over the next year we’ll be seeing these programs roll out across America.”

    How the rebate program works

    The Inflation Reduction Act created two Home Energy Rebates programs: the Home Efficiency Rebates program and the Home Electrification and Appliance Rebates, or HEAR, program.
    New York’s launch in May was just for part of the HEAR program. It will apply for the second at a later date.
    Per federal law, the HEAR program is only available to low and middle-income homeowners.
    New York was initially approved for federal funding to low-income, single-family (one- to four-unit) households. They must have an income of 80% or below their area’s median income to qualify.

    The HEAR program carries a maximum dollar amount per project. For example, New York is paying the following maximum federal rebates:

    Air sealing, insulation and ventilation: $1,600
    Electrical service upgrade (panel box): $4,000
    Electrical wiring upgrade: $2,500
    Heat pump water heaters: $1,750
    Heat pumps: $8,000

    Low-income households are eligible to offset 100% of their project costs, up to $24,000 of combined federal and state funds.
    These rebates are delivered via contractors, who will quote a project’s cost to consumers with rebates applied, according to Harris, of the New York State Energy Research and Development Authority. NYSERDA has a directory of qualified contractors who can make such upgrades.

    New York aims to launch the second phase of the HEAR program in the fourth quarter of 2024, Harris said.
    If approved by the Energy Department, the state would expand the rebate program in a few ways, she said: It would be available to moderate income residents, defined as being between 80% and 150% of area median income; to multifamily buildings; and to the purchase of electric appliances like ENERGY STAR-rated electric stoves and electric heat pump clothes dryers, which would be available at the point of sale from retailers.

    Home Efficiency Rebates program

    By contrast, the Home Efficiency Rebates program is technology-neutral. No state has yet launched such a program, though applications are pending with the Energy Department.
    The value of the rebates are tied to how much overall energy a household saves via efficiency upgrades. The deeper the energy cuts, the larger the rebates, up to $8,000.
    The program is available to all households, regardless of income More

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    Super Micro, Dell shares jump as Elon Musk calls them suppliers to xAI supercomputer project

    Elon Musk, co-founder of Tesla and SpaceX and owner of X Holdings Corp., speaks at the Milken Institute’s Global Conference at the Beverly Hilton Hotel,on May 6, 2024 in Beverly Hills, California. 
    Apu Gomes | Getty Images

    Shares of Dell Technologies and Super Micro Computer jumped Thursday after Elon Musk revealed that the two hardware makers will provide servers to help his artificial intelligence startup xAI develop a supercomputer.
    “Dell is assembling half of the racks that are going into the supercomputer that xAI is building,” Musk said in an X post, adding that Super Micro will also be involved.

    Dell shares climbed more than 3% in premarket trading, while Super Micro popped roughly 5%.
    Musk has promised to build a $500 million “Dojo” supercomputer in Buffalo, New York, and a “super dense, water-cooled supercomputer cluster” at the company’s factory in Austin, Texas. The technology would potentially help Tesla develop the computer vision and large language models needed for robots and autonomous vehicles.
    Musk founded xAI last year as a challenger to Microsoft-backed OpenAI and Alphabet’s Google. Musk also co-founded OpenAI.
    Michael Dell, CEO of Dell, said Wednesday in an X post that his firm is building a “Dell AI factory” with Nvidia to power Musk’s AI bot Grok. More

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    Darden beats on earnings, even as Olive Garden, fine-dining sales drag

    Darden Restaurants reported mixed quarterly results for its fiscal fourth quarter.
    Its acquisition of Ruth’s Chris Steak House fueled a 6.8% jump in net sales, but the company missed Wall Street’s estimates for quarterly revenue.
    The restaurant company reported flat same-store sales growth.

    Olive Garden Italian restaurant sign showing company logo, Spokane Valley, Washington, owned by Darden Restaurants Incorporated headquartered in Florida. 
    Universal Images Group | Getty Images

    Darden Restaurants on Thursday reported mixed quarterly results as Olive Garden’s same-store sales fell for the second consecutive quarter.
    For fiscal 2025, Darden is forecasting that its same-store sales will grow just 1% to 2%.

    Shares of the company rose more than 2% in premarket trading.
    Here’s what the company reported compared with what Wall Street was expecting for the quarter ended May 26, based on a survey of analysts by LSEG:

    Earnings per share: $2.65 adjusted vs. $2.61 expected
    Revenue: $2.96 billion vs. $2.97 billion expected

    Darden reported fiscal fourth-quarter net income of $308.1 million, or $2.57 per share, down from $315.1 million, or $2.58 per share, a year earlier.
    Excluding costs related to the Ruth’s Chris acquisition and other items, the company earned $2.65 per share.
    Net sales rose 6.8% to $2.96 billion, fueled by its acquisition of Ruth’s Chris Steak House and 37 other net new locations.

    Darden’s overall same-store sales were flat for the quarter, dragged down by weaker-than-expected sales at Olive Garden and its fine-dining restaurants.
    Olive Garden’s same-store sales fell 1.5%. Analysts were expecting the Italian-inspired chain to report flat same-store sales growth, according to StreetAccount estimates. Last quarter, Olive Garden’s same-store sales fell 1.8%, driven by a pullback from low-income consumers.
    Darden’s fine-dining restaurants, which include The Capital Grille and Eddie V’s, saw their same-store sales shrink 2.6% in the quarter. That division now includes Ruth’s Chris, but those same-store results won’t be included in the category total for several more quarters.
    LongHorn Steakhouse, which is overtaking Olive Garden as the gem of Darden’s portfolio, was the only segment to report same-store sales growth. The chain’s same-store sales rose 4% in the quarter.
    Looking to fiscal 2025, Darden is forecasting earnings per share from continuing operations of $9.40 to $9.60, in line with Wall Street’s expectations of $9.55 per share. The company is also anticipating net sales of $11.8 billion to $11.9 billion, on the low end of analysts’ expectations of $11.94 billion.
    Darden is projecting total inflation of 3% and same-store sales growth of 1% to 2% in fiscal 2025. Ruth’s Chris won’t be included in Darden’s same-store sales until the second quarter of fiscal 2025. The company plans to spend $550 million to $600 million on capital expenditures. More

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    Is America approaching peak tip?

    Things are big in America. That is true of houses, cars and food portions. Perhaps most shocking of all is the size of tips. In much of the rest of the world, gratuities are a small gesture for good service. In American restaurants they are de rigueur. And they are becoming more generous and more common. For workers who already get them, tips are growing; for those who do not get them, tips may be coming their way. But this cannot go on for ever. Look closer at the tipflation gripping America and a surprising conclusion emerges: the country may be approaching peak tip.As with so much these days, Donald Trump has a hand in this. At a recent rally in Las Vegas, he casually inserted a radical proposal about halfway through his speech. “For those hotel workers and people that get tips, you’re going to be very happy. Because when I get to office we are going to not charge taxes on tips,” he said. It was, he argued, only right to stop the government from going after the earnings of people who provide good service. More

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    America’s rich never sell their assets. How should they be taxed?

    What is income, really? Ask an economist and they might describe “Haig-Simons” income—the value of a person’s consumption of goods and services, plus the change in their net worth over a certain period. A lawyer might refer to Section 61(a) of the IRS Code 26, which defines “gross” income as “all income from whatever source derived”, including but not limited to commission, interest, property deals and wages. An accountant might talk about how to reduce that gross income, via deductions or carve-outs, to a skinnier “taxable income base”.The answer matters. Whether governments should levy taxes on unrealised capital gains, as well as realised ones, is a topic of hot debate. In March, during the State of the Union address, Joe Biden reiterated his commitment to imposing a “billionaire minimum income tax” if re-elected. This would include a 25% tax on unrealised capital gains for Americans with more than $100m in assets, which he expects would raise $500bn (2% of GDP) over a decade. The Supreme Court is also considering the question. Its justices are poised to issue an opinion in Moore v the United States, a case in which the plaintiffs are arguing that a one-off tax on gains from an overseas investment was unconstitutional, since the 16th amendment, which enshrines in America’s constitution the federal government’s right to impose income taxes, does not apply to unrealised income. More

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    Indian state capitalism looks to be in trouble

    India’s stockmarket swooned upon the news that Narendra Modi, the country’s business-friendly prime minister, would return to power diminished and in a coalition after a recent general election. One benchmark, though, fell especially sharply and has yet to recover: the Bombay Stock Exchange’s index for Public Sector Undertakings (BSE PSU). It comprises 56 companies that have some private ownership but remain mostly owned, and entirely controlled, by the state.This curious corporate structure dates back to India’s independence from Britain in 1947 and the country’s subsequent embrace of state planning, which was extended to encompass, in the Marxist-infused language of the time, “the commanding heights of the economy”. This came to include companies in everything from aviation and insurance to artificial limbs and banking. Only when India’s economy opened to the world in the 1990s did the approach change. Since then, politicians have tried, with varying degrees of enthusiasm, to put firms under private control. More

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    Europe faces an unusual problem: ultra-cheap energy

    Owing to the rapid spread of solar power, Spanish energy is increasingly cheap. Between 11am and 7pm, the sunniest hours in a sunny country, prices often loiter near zero on wholesale markets (see chart). Even in Germany, which by no reasonable definition is a sunny country, but which has plenty of wind, wholesale prices were negative in 301 of the 8,760 tradable hours last year.As solar panels and wind farms take over Europe, the question facing the continent’s policymakers is what to do with all the power they produce. Ultra-low—and indeed negative—prices suggest that it is not being put to good use at present, reflecting failures in both infrastructure and regulation. There are three main ways that firms and regulators could establish a more efficient market: sending energy to areas where there is no surplus, shifting demand to hours when energy is plentiful, and storing energy as electricity, fuel or heat. More