WSJ : FDA Approves First mRNA Flu Vaccine in Win for Moderna After Arduous Revie

FDA Approves First mRNA Flu Vaccine in Win for Moderna After Arduous Review
Decision caps seven-month process that included rare refusal to consider shot

  • The FDA approved Moderna’s mRNA-based flu vaccine, mFlusiva, for adults ages 50 and older.
  • In a study of more than 40,000 adults, mFlusiva cut the risk of flu by 26.6% compared with a standard-dose vaccine.
  • The company said it expects to have mFlusiva available for eligible populations in the U.S. for the 2026-27 season.

The Food and Drug Administration approved Moderna’s mRNA-based flu vaccine Wednesday for adults ages 50 and older, clearing the first shot of its kind after a review process that nearly collapsed in February.

The vaccine, called mFlusiva, uses the same messenger RNA technology as Moderna’s Covid-19 shots. It could reach pharmacies in time for the coming flu season, which typically starts in the fall.

Health Secretary Robert F. Kennedy Jr. has questioned mRNA vaccine technology, and the Department of Health and Human Services canceled about $500 million in mRNA research contracts last year in moves that public-health officials questioned as politically motivated rather than rooted in science.

In February, the FDA initially refused to review Moderna’s application at all, a rare move signed by the agency’s then head of vaccine development, Vinay Prasad, who has left the agency. Prasad cited the fact that Moderna tested its experimental vaccine for seniors measuring case counts against a standard-dose flu shot rather than Fluzone High-Dose, the version the FDA normally recommends for that age group.

Moderna was surprised by the FDA’s decision in February. “It does feel like the rules of the game are being changed after it’s been played,” Moderna President Stephen Hoge said at the time.

The agency reversed course days later after Moderna proposed a revised plan that included another trial.

In June, an FDA advisory committee voted unanimously to recommend mFlusiva for adults 50 and older.

Even with FDA approval, the vaccine’s commercial prospects are uncertain. The Centers for Disease Control and Prevention panel that makes national vaccine recommendations remains tied up in litigation after Kennedy replaced its members last year with some outspoken vaccine opponents and a federal judge ruled most of his appointees were unqualified to serve. Doctors and insurers face uncertainty over whether mFlusiva will be recommended only for specific people such as those who are immunocompromised.

Wall Street doesn’t expect the vaccine to generate meaningful sales until the 2027-28 flu season because commercial contracting for seasonal flu shots takes place earlier in the year. The company said it expects to have mFlusiva available for eligible populations in the U.S. for the 2026-27 season.

Traditional flu shots are grown in chicken eggs, a process that takes about six months and forces manufacturers to guess months in advance which strains will circulate. Moderna’s mRNA shot can be made in as little as two to three months, meaning it could better match the actual virus once flu season arrives.

In a study of more than 40,000 adults, mFlusiva cut the risk of flu by 26.6% compared with a standard-dose vaccine. That reduction was 47.9% against flu severe enough to send patients to the hospital or urgent care.

For adults 65 and older, Moderna has tested the shot against Fluzone High-Dose and found its shot generated a stronger antibody response in blood tests. That trial was designed to measure antibody levels rather than tracking flu infections, so Moderna wasn’t able to produce a head-to-head case count against Fluzone High-Dose. That gap is why regulators have required a follow-up study, which Moderna said will enroll up to 800,000 people over two flu seasons.

The approval is a building block for a combination mRNA Covid-flu shot, which the company pulled from review last year after the FDA requested additional flu data.

FT : Jim Ratcliffe’s Ineos doubles down on European chemical sector shares

Jim Ratcliffe’s Ineos doubles down on European chemical sector shares
Company and its investors have bought more than €400mn of equities in listed peers while some of the group’s bonds trade at a discount

Sir Jim Ratcliffe’s chemicals conglomerate Ineos and its shareholders have doubled down on listed shares in European chemical companies, underlining their view that the sector was undervalued.

Ineos Quattro, one of two holding groups the privately held chemicals giant uses to issue debt, last week told investors that it had placed its own €200mn bet on selected chemical companies, according to people familiar with the matter. 

The chemical group’s three shareholders have also made a similar investment, according to people familiar with the matter, although they did not disclose the size.

Together with the €200mn purchase disclosed in May of a “basket of publicly traded liquid equities related to the chemical industry”, Ineos and its shareholders have invested more than €400mn in its chemicals sector peers, according to the people.

The share purchases have drawn the ire of some Ineos creditors who have questioned why the cash was not used to buy back their debt, particularly when some of Ineos’s bonds have been trading at a discount. The group owes investors $19bn.

“The market was frustrated they didn’t buy back bonds,” said one credit investor that holds Ineos’s debt. They added that it suggested that “both management and the shareholders are finally seeing recovery in a market that has been in a four-year downturn”.

While the price of Ineos’s bonds and loans fell for much of last year, the US and Israel’s war on Iran has been a source of reprieve for the group as well as some of its peers. The near closure of the Strait of Hormuz has cut supply from Asia and the Middle East, increasing prices of chemical products and margins.

Ratcliffe, who co-owns football club Manchester United, built Ineos by making a number of bold acquisitions in unloved sectors. He has been a forceful proponent of the European chemical industry, despite its waning profitability in recent years. 

One of Britain’s richest people, Ratcliffe owns a controlling stake in the group while lieutenants Andy Currie and John Reece each hold a roughly 20 per cent stake.

“The ultimate shareholders of the group believe that chemical producers are currently undervalued,” Ineos Group said in private bond offering documents shared with investors in May, as part of a €700mn debt issuance earlier this month.

“As such, the group has invested approximately €200mn in an exposure to a basket of publicly traded liquid equities related to the chemical industry,” it said, adding that it may increase its exposure to those equities and could purchase shares in other companies related to the sector.

Europe’s chemicals producers have struggled in recent years with a deluge of cut-price imports from China, high energy prices and tougher environmental regulations on top of overcapacity and weak demand across the globe.

“We believe the market is significantly undervaluing the chemical industry,” Ineos said, adding that the group had “a strong balance sheet, substantial liquidity and a disciplined approach to capital allocation”.

“We constantly assess the best use of capital across the business, balancing debt management, liquidity and investment opportunities,” it said.

FT : Citadel ‘makes a killing’ Ken Griffin’s hedge fund made billions last week

Citadel ‘makes a killing’
Ken Griffin’s hedge fund made billions last week after it bought the bulk of Situational Awareness’s stock book

Citadel cashes in on Situational Awareness
July was a painful month for many hedge funds, as the AI stocks long beloved by the industry suffered a prolonged sell-off in the first few weeks of the month.

Many multi-manager hedge funds, which magnify their returns with leverage and trade across various asset classes, struggled to avoid losing money. But there was an exception: Citadel.

After Ken Griffin’s firm bought the bulk of the troubled AI-focused hedge fund Situational Awareness’s public equities book, Citadel made billions of dollars last week alone, according to one person familiar with the matter.

The firm’s flagship fund notched 6 per cent returns, while its equities fund made 14.2 per cent, according to a person familiar with the figures. That brings its equities fund to 27 per cent returns for the year, with still five more months to go.

After a huge rally in AI-related equities earlier in the year, hedge funds were stung by a sharp pullback in July. White-hot stocks such as South Korean chipmaker SK Hynix tumbled almost 50 per cent from a peak the month earlier.

The most prominent casualty, of course, was Leopold Aschenbrenner’s firm, Situational Awareness, which notched gains of more than 400 per cent in the first half of the year with its highly leveraged bets on AI companies.

But the sell-off badly damaged the fund. In less than 24 hours last week, it had to sell the majority of its public equity positions to Griffin’s firm in a fire sale.

Citadel was also struggling to generate big returns during the first weeks of July as global equity markets sold off. As of July 24, its flagship fund was roughly flat month to date and stocks continued to drop at the outset of the following week. 

“These are names that trade really aggressively,” said one hedge fund manager who had invested in similar positions to those of Situational Awareness. “They were highly volatile, but they were liquid. So Citadel made a killing.”

Aschenbrenner, who’s 24 years old, was being hit the hardest. He had taken on excessive leverage to amplify returns during the beginning of the year but then faced dire losses as the market began to turn against him.

On Wall Street, a call from Griffin during financial turmoil is a familiar story.

In 2006, Citadel bought the entire trading book of Amaranth Advisors alongside JPMorgan after the fund blew up from a misfired bet on natural gas. It pulled off a similar coup by snapping up the credit portfolio of Sowood Capital Management when it collapsed at the outset of the 2007-8 credit crunch.

“It’s classic Ken,” said one former employee who worked closely with the Citadel founder. “He has played that card many times . . . There are very few [investors] in the world who can do what he did.” 

>>> US After Hours Summary: WDC -11.1%, SNDK -5.4% lower on earnings; SITM +31.4

After Hours Summary: WDC -11.1%, SNDK -5.4% lower on earnings; SITM +31.4%, SOUN +18.7%, AEVA +18.1%, PAYC +16.1% sharply higher on earnings; BLLN -28.7%, FIG -16.9%, APP -16.1%, BROS -11.7% also lower on earnings

After Hours Gainers:

Companies trading higher in after hours in reaction to earnings/guidance: SITM +31.4%, SOUN +18.7%, AEVA +18.1% (also launches optical connectivity unit; also CFO transition), CAI +16.7% (also authorizes $100 mln buyback program), PAYC +16.1%, CLOV +12.6%, FWRD +11.3%, VIR +10.3%, HNST +10.1%, VECO +9.5% (also lands LUMINA+ MOCVD system order for InP laser manufacturing), RELY +8.8%, ARQT +8.7%, RDW +8.5%, MGNI +7.9%, CHYM +7.6%, MATV +7.6%, EHC +6.4%, GTM +6.3%, TPC +6.2%, SEI +6.2%, LB +5.7%, EOLS +5.5%, MSI +5.4%, TROX +5.3%, WTS +4.4%, KRO +4.3%, KLIC +4.2%, ORA +4.2%, ALNT +4.2%, GDRX +4% (also CFO to depart), KNTK +3.5%, TRUP +3.3% (also authorizes $100 mln share repurchase program), ARRY +3%, NVST +3%, SDGR +3%, SOLV +2.9% (also to pursue separation of Health Information Systems business), HCC +2.8%, HHH +2.8%, SBGI +2.4%, CGNX +2.4%, WES +2.1%, VAL +2.1%, DGII +2%, VSEC +2%, CXW +2% (expands buyback program by $500 mln), DHT +2%, MGY +1.9%, PTGX +1.9%, SM +1.8%, OXY +1.8% (also increases dividend), LTC +1.8%, FNF +1.8%, DEC +1.8%, MCK +1.7%, VIAV +1.5%, DOX +1.5%, SRPT +1.4%, GT +1.4%, CACI +1.3%, PR +1.3%, WBI +1.3%, O +1.2%, ALB +1.2%, IONQ +1.1%, EZPW +1.1%, EXPE +1%, BBDC +1%, LEU +0.9%, EBAY +0.8%, RIG +0.8% (also fleet status update), DASH +0.7%, RGLD +0.7%, NOVT +0.6%, APA +0.5%, WMG +0.5%, XNCR +0.4%, JOBY +0.4%, ALL +0.4%, MTDR +0.3%, OBDC +0.3%, ECPG +0.2%, INVA +0.2%

Companies trading higher in after hours in reaction to news: NNBR +6.9% (preferred-stock refinancing and deleveraging transaction), BKD +3.7% (to buy 17 leased communities for ~$157 mln), DAR +2.7% (authorizes $1 bln share repurchase program), ASYS +2.1% (names new CEO and exec Chair), VAL +2.1% (fleet status report), HDSN +2.1% (awarded $210.4 mln Defense Logistics Agency contract), BSX +1.9% (CEO insider purchase), LTC +1.8% (closes $95 mln seniors housing acquisition in Minnesota), DEC +1.8% (Chairman to step down), RAIL +1.1% (adopts limited-duration stockholder rights plan), YSS +0.8% (CFO to step down), COST +0.7% (July comps), TSCO +0.6% (CEO insider purchase), NDAQ +0.5% (reports July volumes), GLOO +0.3% (to acquire Cedarstone)

After Hours Losers:

Companies trading lower in after hours in reaction to earnings/guidance: BLLN -28.7%, LZ -21.9%, MIRM -19.7%, HUBS -19.7% (authorizes $1 bln buyback program), CLFD -17.2%, FIG -16.9%, APP -16.1%, VRRM -15.3%, DAVE -15.2%, UTI -15.1%, RUN -14.5%, LFMD -13%, BROS -11.7% (also to acquire 65 Salad and Go site assets), DUOL -11.3%, WDC -11.1%, ROOT -11%, KYVO -10.7% (also to acquire Agency team and technology), HONA -10.3%, ZG -8.1%, ELA -8.1%, QGEN -6.9%, SNEX -6.9%, ERII -6.9%, BMBL -6.6%, FSLY -6.6%, XNDU -6.6%, AXON -6.5%, AMSC -6.3%, GRAL -6.3%, CF -6.3%, SMR -5.5%, TS -5.5%, SNDK -5.4% (also authorizes additional $14 bln share buyback), CRUS -4.8%, EXEL -4.8%, MUSA -4.8% (also increases dividend), SYM -4.6%, MELI -4.6%, CDE -4.6%, ELF -3.5%, MFC -3.5% ($3.2 bln long-term car reinsurance transaction with Munich Re), MNKD -3.4%, ATEN -3.4%, ABCL -3%, MUR -2.9%, SATL -2.9%, HLF -2.8%, ADMA -2.4%, RVMD -2.4%, RYN -2.1% (also completes timberland swap with RMS), PTRN -2%, NWSA -2%, POWI -1.7%, XYZ -1.7%, FIP -1.7%, PTLO -1.5%, TTMI -1.3%, EVCM -1.3%, STE -1.2% (also restructuring), NTR -1.1%, ETSY -1% (also authorizes new $2 bln buyback program), MKSI -1%, TFPM -0.8%, UUUU -0.7%, AMPL -0.3%, HST -0.2%

Companies trading lower in after hours in reaction to news: CLS -12.3% (stock offering), UWMC -10.9% (partnership with oaktree, suspends common dividend), RDVT -8.2% (stock offering), CRM -5.3% (Chief Engineering Officer to step down), HLF -2.8% (CFO to retire, names successor), CRCL -1.7% (files mixed securities shelf offering), EVCM -1.3% (CEO to step down, names next CEO), CMPS -1.2% (files mixed securities shelf offering), BLBD -0.9% (Ford deal to take over next-gen F-53/F-59 stripped chassis program), PACB -0.8% (names COO as new CEO)

9to5 : iPhone 18 Pro will have three upgrades that have been rumored for years

iPhone 18 Pro will have three upgrades that have been rumored for years

iPhone 18 Pro is coming very soon, and expected to feature three upgrades that have been rumored for years. Here’s what’s coming.

#1: Variable aperture camera
It’s been more than two years since The Information published a report detailing a “variable aperture” camera system coming to iPhone. At the time, it claimed iPhone 17 was the target model for the new feature. Ming Chi-Kuo, however, chimed in that it was instead set for the iPhone 18 line.

Now, iPhone 18 Pro is almost here and the latest reporting indicates variable aperture is indeed coming to the Main camera.

The new feature could unlock a variety of exciting camera abilities, but it all depends on Apple’s implementation. Fortunately we’re just weeks away from the unveiling and full feature reveal.

#2: Smaller Dynamic Island
It’s been almost 10 years since the iPhone X introduced the notch, the first cutout in an iPhone display. It wasn’t until 2022’s iPhone 14 Pro that the current Dynamic Island design arrived, shrinking the cutout.

Now four years later, a smaller Dynamic Island is finally coming with iPhone 18 Pro.

Rumors indicate Apple’s new Dynamic Island cutout will be about 35% smaller than the previous design. This reduction in size is even hinted at by Siri’s new look in iOS 27.

#3: Apple-designed C2 modem
Apple’s in-house modem efforts have been an open secret for years. But it was just last year that the first Apple-designed modem launched in an iPhone: the C1.

Now, rumors indicate Apple plans to switch away from Qualcomm modems in iPhone 18 Pro in favor of its own next-gen C2 chip.

C2 will likely bring speed gains over C1X and C1, but it’s also expected to boast the improved efficiency and privacy benefits of every Apple-designed modem.

Which iPhone 18 Pro features are you most excited about? Let us know in the comments.

TechCrunch : PSA: Apple’s Private Relay can leak your real IP address

PSA: Apple’s Private Relay can leak your real IP address

Apple’s Private Relay, an opt-in feature designed to hide a user’s IP address when they browse the internet with Safari, can be circumvented to reveal the supposedly hidden IP address due to a series of flaws.

Researchers revealed the issues in a blog post on Tuesday. The researchers also set up a website where anyone can check if their real IP address leaks, even if they use Private Relay. In a test on Tuesday, TechCrunch verified that the site was able to reveal our real IP address.

The issue was first reported by 404 Media.

Talal Haj Bakry and Tommy Mysk, the researchers who found the issue, wrote in their blog post that the problem lies with three features in Apple’s web browser engine WebKit, which is used by all browsers in iOS. Private Relay is only available to iCloud+ subscribers, and is not like a Virtual Private Network, or VPN, which protects someone’s IP address at the system level. Private Relay only works while using Safari.

Mysk wrote in a post on X that they chose not to report the issue to Apple because “our past experience with Apple tells us that reporting this issue would involve months of delays, inconsistent communication, and in some cases, denying the issue’s impact entirely.”

Apple did not immediately respond to a request for comment.

Mysk and his colleagues develop a private browser called Psylo, which they say now has mitigations that prevent users’ IP addresses from leaking when using Psylo.

The Information : China’s New AI Gold Rush: World Models

China’s New AI Gold Rush: World Models

The Takeaway
  • Chinese entrepreneurs launch AI labs focused on world models.
  • World model startups attract significant venture capital funding.
  • Chip shortages and founder experience pose challenges for neolabs.

When Hongyuan Lu finished his doctorate program in AI and engineering a year ago, he reached out to some investors to see if he could raise money for a startup to build world models, AI systems that can understand and simulate the physical world. But the investors, who were focusing on AI agent apps at the time, weren’t interested.

This year, the environment is completely different, he said. “World model” has become a new buzz phrase in China’s startup sector, and Lu, who has co-authored academic papers exploring how to make AI understand a virtual spatial environment, started receiving friend requests on the WeChat messaging app from venture capitalists. His startup—FaceMind, which is based in Shanghai and Hong Kong—has raised $20 million in seed money this year from investors including Chinese cybersecurity firm Qihoo 360’s venture fund.

“If I work for big companies, I may not have the freedom to explore world models, because those companies have their own strategies and many other priorities,” said Lu, who turned down a job offer from ByteDance to work on FaceMind.

Lu is one of a huge number of Chinese entrepreneurs, including many university professors or doctoral students, rushing to launch their own AI labs. And while that trend is replicated in the U.S. to some degree, more U.S. neolabs tend to focus on diverse research labs and are run by researchers who have spent time at or even held executive positions at established companies.

What’s different about this new generation of Chinese AI labs is that they’re mostly focused on world models, which simulate real-world environments and aim to approximate the physics of how objects move and interact with the surroundings.

That’s because world models are considered the key to unlocking breakthroughs in humanoids and autonomous vehicles, two areas where China has the world’s broadest and deepest supply chain. The Chinese neolabs think they have a shot, because the race to build world models is still in the early stage, with no front-runners yet, in contrast with the well-beaten path of large language models.

Local venture capitalists say that has produced a frenzy of interest in world models reminiscent of the large language model boom in 2023, when countless new Chinese startups raced to develop large language models in what local media described as the “war of 100 models.”

“The hype around world models right now is unprecedented. Big tech companies, startups and venture investors are all rushing in,” said Jianke Zhang, a second-year AI and robotics doctoral student at Tsinghua University, who co-founded world model startup LatentVerse with his classmate two months ago. “There are so many Ph.D. students launching their own startups now,” Zhang said.

LatentVerse raised tens of millions of dollars in June from blue-chip investors like Hillhouse and is now looking at raising a new round of funding.

The gold rush is so intense that all kinds of startups are starting to adopt the world model label based on their own interpretation of the concept. For instance, PettiChat, a Chinese startup founded in January that develops wearable AI devices for pets, said in April that it is building what will be the first “animal behavior world model,” an AI system aimed at simulating and predicting a pet’s behavior.

Researchers launching their own startups for world models this year have a new formula for raising money, which they’ve dubbed “1-3-5-7.” That means they want to be valued at $100 million in their first funding round, $300 million in their second, and so forth. Some of them are even raising the first three rounds in the same discussion, asking investors to commit to all of them.

Some venture capitalists caution it could be a risky bet to invest in researchers who lack the track record of building frontier models at established labs or tech companies. By comparison, many U.S. neolab founders are researchers who have spent time or even held executive positions at established companies such as OpenAI and xAI.

The list of challenges for Chinese neolabs doesn’t stop here. All of them face a congenital weakness: a shortage of advanced chips, imposed by U.S. export restrictions. Skeptics say the Chinese neolabs will struggle to secure enough chips and talent, once the hype wears off.

While newly founded world model startups are quickly raising money, they will have to compete with deep-pocketed tech giants and well-established AI unicorns for limited chip supplies. Major Chinese AI firms Moonshot AI and DeepSeek, both of which have raised billions of dollars from investors, used Nvidia’s advanced Blackwell chips to train their most recent large language models, as The Information reported.

Researchers at new Chinese startups working on world models say they are renting chips from tech giants that operate cloud services, such as Alibaba and Baidu, to train the models. But they also acknowledge that most Chinese neolabs haven’t found a long-term solution for the compute problem.

War of 100 World Models

In the U.S., a few new world model startups founded by well-known AI pioneers have raised billions of dollars. World Labs, a San Francisco–based startup led by Stanford professor Fei-Fei Li, a pioneer in spatial intelligence research, raised $1 billion at a $5 billion valuation in February. In March, former Meta Platforms chief AI scientist Yann LeCun raised more than $1 billion in a seed round for his new startup, Advanced Machine Intelligence Labs.

What’s happening in the U.S. has sparked intense discussion in China’s tech and investment circles about the importance of world models as the critical step toward large-scale commercialization of humanoids and other automation technologies. The concept of world models resonates particularly strongly in China because the country has massive manufacturing and logistics industries, which provide real-world data from factories and warehouses, as well as strong government support for robotics.

One of the world model startups attracting a lot of attention from investors in recent months is Ziran Yizhi—“natural will” in English. Its founder, Ning Ding, an assistant professor at Tsinghua University, was the main author of a highly influential 2023 academic paper about a technique to fine-tune massive AI models by updating a tiny fraction of their parameters. The Beijing-based startup, founded earlier this year, is valued at about $570 million, and its backers include HongShan, Ant Group and battery giant Contemporary Amperex Technology Ltd., according to a person with knowledge of the matter.

A growing number of established companies from traditional industries are also backing world model startups. Last week, Shenzhen Edge Medical, a Hong Kong–listed medical device company, announced that it has invested in PrimalVerse, a Beijing-based world model startup founded in January by another assistant professor of Tsinghua University. Shenzhen Edge Medical said in a regulatory filing that it will work with the startup to develop AI-powered surgical robots.

Some Chinese AI unicorns that develop video-generation models have shifted their focus to world models. Beijing-based ShengShu Technology used to be best known for its AI video business, Vidu, which competes with ByteDance’s Seedance video models. In April, ShengShu released Motubrain, a world model that aims to serve as the brain for robots to navigate the physical environment. Shengshu now describes itself as a “general world model company.”

In January, PixVerse, another AI video-generation startup that competes with ShengShu, launched a “real-time world model,” R1, which allows users to create a realistic virtual world and keep making changes to it in real time, all with text or image prompts. Earlier this month, PixVerse announced PixVerse Game Engine, a new software framework powered by the R1 model for building interactive videogames.

While some investors are starting to describe the world model movement as a bubble, founders say the rapid concentration of capital and resources could lead to real advancements.

“Without this bubble, it may not be possible for breakthroughs to happen,” Zhang said.