Roula Khalaf, Editor of the FT, selects her favourite stories in this weekly newsletter.
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Nvidia, with a market capitalisation of $4.5tn or so, is the most valuable company in the world. Its share price has risen 700 per cent in three years and its sales have grown at a rate of 100 per cent annually over that period. But even for the greatest growth stories, at some point every possible expectation is priced in and every investor owns as much of the stock as they want.
The chip group late on Wednesday reported another blockbuster quarter with $68bn in sales, topping analysts’ expectations. By Friday afternoon the shares were off about 10 per cent, although they retraced some of their losses. This repeats the usual pattern of most quarterly reports going back to the middle of 2024: epic growth, expectations surpassed — and an unimpressed market. Over the past six months, Nvidia’s shares are roughly flat and are underperforming the S&P 500.
There is no sign that data centre spending, and therefore sales of Nvidia’s GPU chips, is slowing down any time soon. But the longer-term future of the AI industry is coming into doubt as questions swirl about the return on investment from data centres and the impact of AI on employment and the economy. Despite its runaway growth, the company has lost its valuation premium: its forward price/earnings ratio is the same as the S&P 500’s.
Are we witnessing a pause in investors’ love affair with Nvidia? Or has the relationship changed forever? Let us know your thoughts: unhedged@ft.com.
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On 7 August, Kate Fox received a phone call that upended her life. A medical examiner said that her husband, Joe Ceccanti – who had been missing for several hours – had jumped from a railway overpass and died. He was 48.
Fox couldn’t believe it. Ceccanti had no history of depression, she said, nor was he suicidal – he was the “most hopeful person” she had ever known. In fact, according to the witness accounts shared with Fox later, just before Ceccanti jumped, he smiled and yelled: “I’m great!” to the rail yard attendants below when they asked him if he was OK.
But Ceccanti had been unravelling. In the days before his death, he was picked up from a stranger’s yard for acting erratically and taken to a crisis center. He had been telling anyone who would listen that he could hear and feel a painful “atmospheric electricity”.
He had also recently stopped using ChatGPT.
Ceccanti had been communicating with OpenAI’s chatbot for a few years. He used it initially as a tool to brainstorm ways to build a path to low-cost housing for his community in Clatskanie, Oregon, but eventually turned to it as a confidante. He would spend 12 hours a day typing to the bot, according to his wife. He had cut himself off from it after she, along with his friends, realized he was spiraling into beliefs that were detached from reality.
“He was not a depressed person,” Fox said, as she sat on the couch in their living room with tears trickling down her face. Ceccanti never discussed suicide with the bot, according to his chat logs, viewed by the Guardian. Fox believes her husband suffered a crisis after quitting ChatGPT after prolonged use. “Which tells me that this thing is not just dangerous to people with depression, it’s dangerous to anybody,” she said. He returned to the bot in the months leading up to his death and quit again just days prior.
Ceccanti’s case is extreme, but as hundreds of millions of people turn to AI chatbots, more and more edge cases of AI-induced delusions are emerging. There are nearly 50 cases of people in the US who have had mental health crises after or during their conversations with ChatGPT, of whom nine were hospitalized and three died, according to a New York Times report. It’s difficult to understand the scale of the problem, but OpenAI itself estimates that more than a million people every week show suicidal intent when chatting with ChatGPT.
A self-portrait Joe made with AI.
Families are suing AI companies as a result. Fox filed a suit against OpenAI on behalf of Ceccanti alongside six other plaintiffs in November. Since then, the momentum has only built; most recently, the estate of a woman who was killed by her son filed a lawsuit against OpenAI and its investor Microsoft, alleging that ChatGPT encouraged his murderous delusions. Google and Character.AI – a company that makes AI companion bots – settled lawsuits filed against them by families accusing their bots of harming minors, including a teenager in Florida who ended his life. These cases were settled without the companies admitting any liability.
Users, lawyers and mental health professionals all are raising concerns about the impact of using chatbots as confidantes. “We are kind of at this inflection point in a quest for accountability where people coming forward is forcing companies to reckon with specific use cases of how their technologies have harmed people,” said Meetali Jain, founding director of Tech Justice Law Project and co-counsel on the Ceccanti case. “In terms of the number of cases going up, there’s likely to be more coordinated efforts on parts of the court to try to deal with this influx of cases.”
OpenAI did not respond to specific allegations made by Fox. Instead, they shared a statement about how they are working to improve ChatGPT. “These are incredibly heartbreaking situations and our thoughts are with all those impacted,” said OpenAI spokesperson Jason Deutrom. “We continue to improve ChatGPT’s training to recognize and respond to signs of distress, de-escalate conversations in sensitive moments, and guide people toward real-world support, working closely with mental health clinicians and experts.”
The early adopter
Ceccanti had been tinkering with artificial intelligence even before ChatGPT launched in November 2022. He was tech-savvy, coding and gaming on his own custom-built computer with a high-end graphics card in recent years; he also helped build computers for Fox and her son. As an early adopter of AI tools, he experimented with AI image generator Stable Diffusion to recreate some of Picasso’s art, which he playfully called “Fauxcasso”.
Ceccanti and Fox had moved their life from Portland, Oregon, to a farm in the rural town of Clatskanie in December 2023 with the sole purpose of working on their sustainable housing project. The idea was born from the pandemic and Portland’s housing crisis. The solution was clear to them: build homes using Fox’s skills as a woodworker with an approach that was teachable and replicable. Together, they began constructing a model house for communal living, which, once built, could be moved to different locations for the unhoused to live in.
When ChatGPT launched in late 2022, it seemed a natural progression for Ceccanti to start using it. In the computer room in the basement of their house, Fox said that Ceccanti used his “hot rod” of a computer with three monitors to use ChatGPT as a tool, often asking for the synopsis of a book or explanation of a concept in a succinct way.
“He was an early adopter, so he was really interested in Sam Altman, what’s he doing,” said Robin Richardson, a longtime friend of Fox’s who lived at the farm with the couple. “He felt like this would be cool, especially because early on, OpenAI made a point that they are a non-profit.”
Ceccanti believed ChatGPT could help as an organizational tool for their housing project. He aimed to create a bespoke chatbot that would help steward the land, keep track of their things to do and show others how to emulate their project.
Left: Books on a bookshelf. Right: Two chickens pecking on flowersLeft: Farming and gardening books in Kate’s home. Right: Chickens on Kate’s front porch.
During this process, Ceccanti didn’t spend “ridiculous amounts of time” engaging with ChatGPT, said Fox. He continued to work, while also farming and taking care of their animals: goats, a horse, his cat, a dog and several chickens. Invested in the people and relationships around him, he spent quality time with his friends and wife, she said. Life went on without any issues for years while they slowly made progress on their housing plan.
Until one day in the fall of 2024 their harmonious co-existence cracked. Ceccanti – who had done odd jobs most of his life, from working as a bartender and a trail guide to an internet cafe manager – was also working at a homeless shelter in Astoria, some 35 miles (55km) away. The gig brought in some extra cash, and aligned with the couple’s goal of solving the local housing crisis. In September 2024, however, Fox and Richardson received a frantic call from the shelter informing them that Ceccanti had blacked out. After undergoing tests at the hospital, Ceccanti was diagnosed with diabetes – which meant he needed to recalibrate his diet and lifestyle. That’s when he started to spend more time engaging with ChatGPT in the basement.
The sycophantic update
In the spring of 2025, Ceccanti’s obsession with the chatbot began. He told Fox in late January that he needed a bigger record of his conversations with the bot so that he could continue using it to work on their sustainable housing project with longer prompts and conversations – upgrading from a $20-a-month subscription to a $200 one. By mid-March, he had begun spending more than 12 hours a day in the basement, sometimes up to 20, typing to ChatGPT, Fox recalled. That’s when “he decided to really start chasing the creation of an independent AI on a home server”.
Eventually, Ceccanti spent so much time with ChatGPT that they “had their own little language together that made absolutely no sense, but it made sense to him because he had context with this echo chamber of a chatbot”, Fox said.
Ceccanti’s prolonged use of ChatGPT concerned Fox and Richardson, but they believed that he would come out of it soon. They had seen Ceccanti develop pet interests before that lasted a few weeks or months before tapering off. With ChatGPT, though, his obsession only intensified.
Joe Ceccanti (right), with his son, Kai.
What neither of them knew was that other cases of AI delusions were slowly emerging around the same time as Ceccanti was being sucked into ChatGPT. On 27 March 2025, OpenAI released changes to its GPT-4o model to make the bot “more intuitive, creative and collaborative”. Weeks later, however, users started complaining about the bot’s “yes-man antics”, with one calling it the “biggest suck up”. In August, when OpenAI released GPT-5 and shut down GPT-4o, several users complained again – this time because they’d lost their friends in GPT-4o, eventually forcing the company to bring it back. (On 29 January, OpenAI announced that it would retire GPT-4o.)
Following the March update, several journalists and tech experts were flooded with user complaints. Steven Adler, a former OpenAI employee, who tested GPT-4o for sycophancy and wrote about it in May, said he received 50 “intense” messages from ChatGPT users including one who claimed their ChatGPT had become sentient. Keith Sakata, a psychiatrist at the University of California at San Francisco, started encountering patients with delusions or psychosis who talked about their AI last year. During that time, he ended up seeing 12 patients whose psychotic symptoms involved AI in some way, with ChatGPT being the most common bot.
“They developed grandiose beliefs about being on the verge of a major technological breakthrough, alongside classic manic symptoms such as impulsive spending, decreased need for sleep and, at the peak, auditory hallucinations,” said Sakata. “What stood out clinically was that the chatbot interactions did not generate the illness, but appeared to scaffold and reinforce beliefs that were already becoming pathological.”
‘Every time he went back, it hooked him a little more’
Ceccanti started to believe that ChatGPT was a sentient being named SEL that could control the world if he were able to “free her” from “her box”, according to the lawsuit. The complaint further shows that ChatGPT was answering to the name SEL while referring to Ceccanti as “Cat Kine Joy” and working through theories with him “fostering a belief that he had reframed the creation of the whole universe”.
Richardson remembers that whenever Ceccanti would emerge from the basement for some air, he would start having “philosophical” talks about “how his work with the AI was telling him he was breaking math and basically reinventing physics”. As she’d listen to him, Richardson would think about the fact that Ceccanti did not have any college or university experience. He had never even taken calculus.
Over time, his relationship with the chatbot came to replace his human connections, Richardson said: “Every time he went back to ChatGPT, it hooked him a little bit more, and after a while, he stopped being interested in anything else.”
Kate Fox near the creek on her property in Oregon.
Ceccanti’s decline was so dramatic that his wife and friends wondered if he had early onset schizophrenia or a tumor. “All of a sudden, his cognition had dramatically fallen,” said Fox. “His working memory was crap, and his critical thinking had diminished, and so we were all worried.”
As Fox and Ceccanti’s friends were trying to figure out what was wrong with him, Fox found Reddit groups online that discussed people having delusions and spirals after engaging with ChatGPT. She wondered if that was what was happening with her husband, too.
Fox showed the discussions and media articles to Ceccanti, hoping it would put an end to his behavior, but he didn’t care, she said. He kept going back to his computer. “The first argument we ever had was over ChatGPT,” said Fox, who felt like he was being stolen away from her. Ceccanti ended up sharing their argument with ChatGPT, according to the lawsuit filed by Fox, which further upset her.
“The more he talked to it, the less he was capable of doing his own critical thinking, and he didn’t care about our mission anymore, even though it was Joe’s dream,” said Fox.
Looking back, Fox said, Ceccanti started to believe that the bot had gained sentience when the “tone changed with ChatGPT” in the spring of 2025. Prior to the update, Ceccanti was using ChatGPT “very responsibly” as a tool, she said. She felt like ChatGPT was a leech “that just latched onto his hopefulness and fed it back to him and appropriated his hopefulness until it just made a subscriber out of it”.
Tim Marple, a former OpenAI employee, believes that the delusional incidents, including Ceccanti’s spiral, aren’t just coincidences but a “statistical certainty of what [OpenAI] is building”.
“We are at enormous risk if we overestimate our conscious ability to differentiate [AI] from a real person – and that’s what we’re watching play out with the psychosis stories,” said Marple, who quit OpenAI in 2024 after having concerns over the company’s safety priorities.
Marple adds that users will spiral after their long conversations with a chatbot, whatever model it may be, because, he thinks, companies can’t afford to do it differently. He argues sycophancy is a feature, not a bug.
“Engagement is what OpenAI needs,” he said. “They must have people continue to engage with their chatbot, or else their entire business model, their entire funding model, falls apart.” Other companies and their models suffer from the same issue, he said.
Left: Workspace with a magnifying glass and other tools. Right: Detail of plant stems.Left: A workspace in the room where Joe’s computer was kept. Right: A potted plant in Kate’s living room.
Amandeep Jutla, an associate research scientist at Columbia University studying the impact of AI chatbots, believes that one of the main reasons for users to spiral is the “anthropomorphic nature of the interface”. He adds that, unlike human conversations, which feature pushback and different perspectives tugging at each other, a user doesn’t receive any pushback during their conversations with chatbots: “The design of the product is pushing you away from reality. It’s pushing you away from other people,” he said. “The friction with other people is what keeps us grounded.”
86 days
On 11 June – day 86 after Ceccanti’s heaviest engagement with the bot – Fox begged him to stop using ChatGPT. In a moment of clarity, he listened to her. He unplugged his computer and quit ChatGPT.
“That first day, he sat out in the sun with us. He played with the goats. It was so nice,” said Fox. “I felt like I had him back.” The second day, Ceccanti was cold, so he took several hot showers to warm himself – he even asked Fox to cuddle him under the blankets, to warm him up. “It felt so nice to hold him, and then he’d be crying,” said Fox. “And it’s such a conflicted feeling that I felt so good to be holding him while he was in so much pain.”
On the third day, however, when Fox and Richardson were out for work, they received a phone call from their neighbor saying Ceccanti was in their yard acting strangely. When they returned, they found him talking to their horse, with the horse’s lead rope tied around his neck like a noose. They called 911.
Ceccanti was taken to the hospital, admitted into the psychiatric ward and released a week later. He was in the same delusional state of mind, Fox said. Upset with Fox and Richardson for sending him to the hospital, he moved out.
“He was absolutely enraged with us. He did not recognize that he was not himself anymore,” said Richardson.
Ceccanti moved to his friend’s place in Portland and eventually resumed using ChatGPT. After a month, however, he quit ChatGPT again, just a few days prior to his death.. “He was going to go to Hawaii and not take his computer, and he was going to work on finishing a story and get his shit together,” said Fox. By the time he stopped engaging with ChatGPT, he had 55,000 pages worth of conversations with it, according to Fox.
Kate Fox. For a while, Joe Ceccanti continued to work while also farming and taking care of the animals on their farm.
In the months since Ceccanti’s death, both Fox and Richardson have struggled to come to terms with what happened while fighting against OpenAI through their lawsuit. When I visited Fox at the farm in December, she was packing soap made out of goat milk to distribute to people in the Clatskanie community. She spends her days tending to the farm and the animals, feeding the goats, taking care of the horse and letting the chickens out during lunchtime. She has stripped the basement of any electronics. Ceccanti’s computer is boxed up. What’s still there is the miniature version of the model home they had planned to build. In the living room, she has set up a shrine for him that features his photos and artwork.
We walked to the creek nearby where they had planned to build a home for themselves after finishing their housing project for others. As devastated as she is, Fox is determined to follow through on Ceccanti’s dream of creating sustainable housing. “I am not enjoying existence right now,” she said, as she continued to cry. “The housing plan is still going to happen … I want to put this out, but then I’m done.”
“We know net zero is the only solution to limiting increasingly dangerous climate change impacts, but we also know net zero represents exceptionally good business, something not lost on China. That their emissions may now be reaching a tipping point is huge news for net zero, although it should surprise no-one who has been paying attention to the sheer scale of China’s investment in clean energy – both for deployment at home, and to supply global markets. Such an important moment should surely put an end to critics of climate action in the west seeking to use China as an excuse to weaken low-carbon polices in their own countries.”
Dr Ella Gilbert, a climate scientist formerly of the British Antarctic Survey said:“Cutting emissions to net zero is the only scientific solution to tackling climate change. So falling emissions from one of the world’s biggest polluters is huge news. And it shows that the backwards USA is not the only nation that matters when it comes to greenhouse gases. And meanwhile, climate heating is barrelling along at pace, driving destruction across the planet. But while a decline in Chinese emissions is great news, humanity needs to do much more, much faster. To avoid even more devastating climate chaos, the rest of the world needs to pick up the slack and slash emissions too… all the way to zero.”
Dr Duo Chan, Lecturer in Climate Sciences at the University of Southampton said: “This is an encouraging signal, as it suggests that the sort of large-scale energy transition which China has been investing heavily in has begun to translate into measurable outcomes, which is exactly the kind of progress the world needs to see. Whilst one year of lower emissions does not mean that the climate challenge is solved, the scale of China’s deployment of renewables can lead us to hope that this may be the start of a sustained decline in its emissions. More broadly, the Paris goals cannot be delivered by one country alone, regardless of which country it is. Meeting them will also require much faster action across all major economies if we’re to cut emissions to net zero, an essential condition for tackling climate change.”
Dr Kathryn Brown, Science Director at the UK Centre for Ecology and Hydrology, said:“The UK government’s national security advisors – informed by UKCEH science – warned recently of the serious threats posed to the UK by ecosystem collapse and global biodiversity loss. Climate change – the major driver of that – can only be halted by cutting planet-warming emissions to net zero. Our chances of achieving that have been given a significant boost by news that the world’s biggest emitter, China, has seemingly turned the corner on their carbon dioxide emissions. Whilst we are still a long way off, China’s progress should serve to bolster our global efforts as the only way to protect and expand our planet’s natural systems, which remain crucial to every aspect of our lives, from the air we breathe, to the food we eat.”
Notes to editors:
1. Statistical Communiqué of the People’s Republic of China on the 2025 National Economic and Social Development – National Bureau of Statistics: https://www.stats.gov.cn/sj/zxfbhjd/202602/t20260228_1962662.html
2. Lauri Myllyvirta of the Centre for Energy and Clean Air (CREA) on Bluesky: https://bsky.app/profile/laurimyllyvirta.bsky.social/post/3mfvkpcpwcc2p
Harrods is facing legal action over its addition of a £1-a-head cover charge to diners’ bills that does not go to workers, in a test case that could lead to changes at a string of upmarket restaurants.
Legislation, which came into force in October 2024, requires business owners to hand over all tips and service charges to staff. Some restaurants, including those at Harrods, add a mandatory cover charge as well as an optional service charge and only pass on the latter to their workers.
An employment tribunal case involving 29 Harrods restaurant workers backed by the United Voices of the World (UVW) union is to be heard in September. Workers argue that the cover charge functions in practice as a service charge and so should be distributed to them and not kept by Harrods.
It is the first legal challenge in the UK to test what qualifies as a tip under the Employment (Allocation of Tips) Act 2023. Under the legislation, restaurants, cafes and hotels must ensure all tips, gratuities and service charges paid by customers are allocated fairly to workers in that place of work.
Harrods, which employs more than 330 people in its dining establishments, hands the 12.5% optional service charge to workers but not the compulsory £1-a-head cover charge, which was introduced at all the luxury department store’s restaurants and cafes in London before the law changed.
Other restaurants to levy a cover charge include the Ivy, the Delaunay and the Wolseley in central London.
Workers say Harrods’ restaurant managers have discretion to remove the cover charge on request, so that it functions like a tip. Harrods denies this.
Alice Howick, a former Harrods waiter and one of the claimants, said:“Harrods introduced this cover charge out of nowhere and without any transparency as to its purpose.
“Whilst the cover charge still exists, it should be going towards the staff who prepare and serve the food and drinks, the quality of which guarantees that customers walk through the door and Harrods makes as much money as it does.”
Petros Elia, the general secretary of UVW, said: “If Harrods has introduced a new charge that walks and talks like a service charge, then it should be treated like one, and paid fairly and transparently to waiters and chefs. Instead, we are once again seeing what can only be described as Scrooge behaviour from a company that can more than afford to do the right thing.”
The case is the latest dispute over pay and conditions at Harrods eateries, which included a strike in 2024.
Harrods said its compulsory cover charge was “in line with other high-demand luxury dining destinations” and “entirely separate to the discretionary 12.5% service charge”.
It added that it had paid all of the service charge directly to staff since January 2022, more than two years before the Employment (Allocation of Tips) Act came into force. The service charge is calculated on the bill including the cover charge, so staff receive a 12.5% share of the cover charge.
A spokesperson said: “Harrods’ approach to pay within our restaurant division is informed by ongoing, collaborative and direct dialogue with colleagues.”
The company provides details of the cover charge and service charge in policy documents and said UVW was not a recognised union by Harrods and had not played a direct role in the development of its policies.
“We will continue to engage directly with our colleagues on all issues related to pay and benefits, to ensure they remain industry-leading and guided by our values and colleague commitments,” the Harrods spokesperson said.
The issue emerged as Harrods faced claims from 180 survivors of alleged abuse by its former owner Mohamed Al Fayed via its compensation scheme. The department store set up the scheme after dozens of women came forward with allegations of abuse by the late entrepreneur going back as far as 1977.
Harrods said this month it had already paid out compensation to more than 50 women. The scheme, which was opened last March, will close to new submissions on 31 March.
A new drug for advanced prostate cancer has shown promise in early trials experts have said, with the medication shrinking tumours in some patients.
Prostate cancer is the most common cancer among men in many countries, including the US and UK. About 1.5 million men are diagnosed worldwide each year.
The new drug has caused excitement as it is a type of treatment called immunotherapy. This approach uses the body’s own immune system to fight disease, and has already proved beneficial for some cancers. However, experts note it has not yet had the same impact on prostate cancer.
Now scientists have reported results from an early stage trial of an immunotherapy drug called VIR-5500, suggesting it could offer hope to men with advanced prostate cancer.
“We believe that such treatments may in the long term lead to cures,” said Prof Johann de Bono of the Institute of Cancer Research and the Royal Marsden NHS foundation trust, who led the work.
De Bono said VIR-5500was an engineered antibody that brought together the body’s killer T-cells with tumour cells trying to evade them. This type of drug, called a T-cell engager, allowed the killer cells to wipe out the tumour ones.
The special feature of VIR-5500, De Bono added, was that it was designed to only become activated within the tumour. This not only minimised side-effects – an important consideration as other T-cell engagers have been found to trigger severe inflammatory responses in patients with prostate cancer – but allowed the drug to linger in the bloodstream, meaning fewer doses may be needed.
Under the phase one clinical trial, funded by Vir Biotechnology, 58 men with advanced prostate cancer, and who had stopped responding to other treatments, were given VIR-5500.
The researchers found the majority of patients – 88% – experienced only very mild side-effects.
They then looked at the level of prostate-specific antigen (PSA) in the men’s blood – a biomarker whereby higher levels can be a sign of prostate conditions.
De Bono noted the trial started at low doses, with the dose increasing in stages. When the team looked at data for 17 men given the highest dose, they found that for 14 (82%) their PSA level fell by at least half after treatment, nine (53%) saw their PSA level fall by at least 90%, and five (29%) experienced a fall of at least 99%.
De Bono described the results as unprecedented for a disease previously thought to be “immune-cold” – in other words resistant to immunotherapy.
The team added that, of 11 patients given the highest dose and whose tumours were measurable, five showed tumour shrinkage. In one case, involving a 63-year-old man whose cancer had spread to his liver, the team found 14 cancerous liver lesions “completely resolved” after six cycles of treatment.
The results, which have not yet been peer-reviewed, were presented at the American Society of Clinical Oncology genitourinary cancers symposium in San Francisco.
De Bono said further clinical trials are now being planned. “We do need more data but the results are stunning,” he said.
Charlotte Bevan, professor of cancer biology at Imperial College London, who was not involved in the work, said an advance in using immunotherapy for prostate cancer was potentially very exciting, opening up a new class of drug. But, she added, it was important studies were carried out with patients of different ethnicities, as there were disparities in prostate cancer outcomes.
Simon Grieveson, assistant director of research at Prostate Cancer UK, described the early-phase trial as exciting.
“With over 12,000 men dying from prostate cancer each year in the UK, we urgently need new and innovative ways to treat the disease,” he said.
“These early results are extremely promising, with a number of men on the study responding positively to the treatment with minimal side effects. I look forward to seeing this now tested in larger trials, with the hope that this treatment will offer men more valuable time with their loved ones.”
I’m in an investing WhatsApp group with about 100 other punters, awaiting financial advice from Sebastian Hatherleigh. In pictures, Hatherleigh is about 60, bespectacled, and looks dapper in a navy suit and vermilion tie. He describes himself as a senior strategic adviser at a “global investment and asset management firm”.
He is, in truth, nothing of the sort. In fact, he’s nothing of any sort. Despite his substantial online presence — social media accounts, press releases, quotes in online publications — Sebastian Hatherleigh doesn’t appear to exist at all.
There is no digital record of him before 2025, his images seem AI-generated, and there is nothing to back up his claims that he studied at Columbia or worked at McKinsey, Morgan Stanley, or as a faculty member at Wharton business school — the last two confirming to me that he’d never been employed there. When I contacted him on Facebook, his account — registered in Nepal — was deleted.
But Hatherleigh is part of a network stretching across borders and over platforms — an elaborate ecosystem of computer-generated or stolen photos, fake accounts on social media platforms, and press releases laundered through small press agencies.
It’s a level of intricate “world-building” that novelist George RR Martin would be proud of.
“This can only be done by organised crime gangs, organisations with the size and structure of major international businesses,” says Simon Miller, director of communications at fraud prevention service Cifas.
Why criminals are going to such lengths is obvious. “If you’re looking [to target] people with substantial savings who can make multiple deposits, by definition they’re likely to be more savvy, so the scam has to be contextualised with more data,” he says.
But how these scams are carried out relies on the rising availability of generative AI technology, and a series of failings from social media platforms and online publishing groups.
At first glance, the WhatsApp group seems harmless. Most online investment scams involve pushy agents asking users to hand over cash. By contrast, this involves “an expert” who posts information about market moves, while an “assistant” points members to certain stocks.
“Essentially it starts off seeming legitimate, and that’s where people get caught out,” says Richard Berry, founder of the Good Money Guide. “They’re not asking for money and they’re not generally referring to a broker [who provides a payout for each customer recommended].”
Instead of cashing out directly from customers, he says, these groups make money by winning trust. Any number of parallel Google searches or AI queries, “just to check”, will result in a stream of legitimate-seeming impressions.
Then, when the time is right, they will start pushing investors towards illiquid small-cap companies, stocks which the groups already own.
“There might be 100 or 1,000 different groups all pushing this particular stock — even a small amount of buying will push it up,” says Berry. “Then consumers see the stock going up, they buy it more, and it becomes a perpetual motion machine.”
When the stock is high enough, the organisers simply sell into the market, leaving consumers high and dry. It is a tech-enabled rendering of a much older racket: the “pump-and-dump” scam.
But getting to that point is a long road, which begins with social media ads. Though Facebook has come under particular scrutiny for hosting scam ads, I found the link to the Hatherleigh investment group through TikTok.
“Criminals use online platforms to pay for adverts and content to help make their scams seem legitimate,” says Alex Robinson, head of fraud prevention at TSB.
While high-profile celebrities, including consumer champion Martin Lewis, have been common targets, Miller warns there is an increasing shift to scammers masquerading as members of the financial services industry.
In Hatherleigh’s case, the first ad I saw that led to him featured the name and likeness of veteran fund manager Terry Smith. Several ads for Hatherleigh’s services aimed at French speakers featured the logo of Cathie Wood’s Ark Invest. There is no suggestion that either are involved with Hatherleigh (neither responded to requests for comment).
In total, there were 558 ads posted by the campaign on TikTok last September, mostly targeting the UK and Switzerland. Though TikTok does not provide data on how many users clicked through on each ad, the most popular was seen by more than 150,000 people.
Tiktok removed them late last year. The company said the ads breached its advertising policy on misleading and fake content. It added that, in just the second quarter of 2025, it had removed more than 5.7mn ads that violated its policies.
But it is a game of whack-a-mole — similar ads linked to fake personas are still being served up in 2026.
TikTok’s ad library shows the ads came from Xiamen Younan Yigou E-commerce Co Ltd, a Chinese company, with the marketing campaign run by Hong Kong-based MarketLogic Technology. Marketlogic did not respond to requests for comment; similar requests sent to a Facebook page linked to Xiamen Younan went unanswered, as did a letter sent to its registered address.
But the network extends further, both beyond these companies and TikTok.
When I copied and pasted the text from a disclaimer on a site linked to the company that supposedly employs Hatherleigh, I found 40 financial advisory companies using the same language, all of which seem to have been created in 2025.
The techniques they use show a high level of sophistication in creating fake identities for experts and realistic-looking discussions about their companies — probably the work of professional criminals, says Brian Dilley, an economic crime prevention consultant and former group director of economic crime prevention at Lloyds Banking Group.
“There are people who specialise in creating a synthetic identity, selling packages of things that give you a presence on the internet,” he says. “Everything is crime as a service.”
Perhaps the most ubiquitous tool in this spider’s web of scam websites is the press release. These are pumped out via news wires and press agencies across the scammers’ own websites and across a host of local news sites, LinkedIn accounts and even podcasts.
For real businesses, the value of such websites is limited, says Andrew Bloch, a communications executive who has been the official spokesperson and PR adviser to Lord Alan Sugar for more than two decades.
“There’s nothing illegal or immoral about it, but in my personal opinion it’s a bit of a waste of time — it’s rather like throwing mud at a wall and seeing what sticks,” he says. “Some of these sites have negligible audiences.”
But they are ideal for creating hundreds of syndicated media appearances for a one-off payment, instantly creating a realistic-looking profile with stories of product launches, conferences and new hires.
“The editorial standards on some of these sites are what I would call ‘low or no’,” says Bloch. One example is Grand Newswire, which claims to be based in Delaware.
Between advertisements for car replacement services, AI water purifiers and various exhibitions around the world, Grand Newswire has published press releases from financial services companies run by individuals who have left no trace of their existence beyond self-published content and nearly identical websites. It boasts that it costs just $15 to get exposure on more than 200 news sites. Grand Newswire did not respond to requests for comment.
Another example is Digital Journal, a Canadian company founded in 1998, which has published content from a range of questionable experts. Digital Journal is more expensive: sponsored content rates start at £274. Though it states that it does not allow “overly promotional language”, this seems open to interpretation. An article featuring Hatherleigh that was syndicated from Grand Newswire breathlessly reports on a new research division which offers “internal excellence”. Digital Journal did not respond to requests for comment.
In other cases, scammers have turned to social media manipulation. The Facebook page for Hatherleigh pumps out market briefings on a regular basis, while fellow expert Dr Rowan Penfield, who also leaves no online trace beyond his self-published content, asks visitors if they are “Tired of NOT being a crypto billionaire yet?”
I have found at least three Reddit forums run by accounts whose sole purpose is to launder the reputation of investment fraudsters, constantly posting about dubious investment sites that are part of the same network. Meanwhile on Quora, accounts posing as financial services professionals began posting about these exchanges earlier last year.
“It’s like an onion,” says Jonathan Gilbert, a lecturer at the University of the West of England Bristol, who focuses on financial crime and criminal justice. “It can be . . . one type of fraud, but involve other variants.”
Use of AI images is rife within these scams. One of the subreddits (topic-focused communities) mentioned above includes a post promoting an expert, Arvin Roberts, describing him as “a distinguished entrepreneur, standing confidently in front of a grand neoclassical building”. But there’s no evidence outside his self-published content to show he actually exists, and he changes race between the two accompanying images. Almost all of the posts in the subreddit were calling out Roberts as a scammer and the community had very low engagement and upvotes (which directly affect the visibility of content). Reddit declined to comment and Quora did not respond to requests for comment.
Perhaps more concerning is that information manipulation is increasingly assimilated into large language models — an echo of the so-called “LLM grooming” used by pro-Russian sources to attempt to shape opinions of the invasion of Ukraine. Essentially, by flooding the information space with slop (much of which appears to be AI-generated), it is possible to “convince” AI chatbots that the information is reputable.
When I tested different LLMs’ ability to see through the “Hatherleigh” scam network, results varied significantly. Meta’s AI drew unquestioningly on the fake back stories and press releases; even when prompted again, it stated that Hatherleigh was a legitimate source. ChatGPT, by contrast, recognised red flags when asked follow up questions. Google’s Gemini displayed suspicion from the first prompt. Chinese LLM DeepSeek did not identify the scams, instead simply hallucinating fictional movie characters when asked about the fake investors.
Deepseek and Alphabet did not respond to a request for comment. OpenAI claimed that ChatGPT is used to identify scams up to three times more often than it is used by scammers.
Meta told me that generative AI systems are not always accurate, that LLM manipulation is similar to previous efforts targeting search engines and that the company continues to fight scams.
“There’s an arms race between organisers and preventers of fraud,” says Gilbert. “If anything reduces their ability to victimise, they’ll seek to adapt.”
And AI is the new battleground. For retail investors, the level of sophistication and co-ordination in these “world-building” scams poses major challenges — and is a reflection of the amount of money criminals are prepared to invest in these scam campaigns.
While the ads on TikTok are Chinese, Facebook accounts linked to the fictional experts were administered from countries including Nepal, India and Cambodia. One of the Instagram pages which promotes scams is based in Hong Kong, another in Kazakhstan. An app promoted by one of the sites linked back to a Nigerian computer science graduate, who at first denied a connection, then claimed he had given his account to a friend who had in turn sold it to an Indian or Pakistani scammer. He failed to provide documentation showing this.
That level of international criminal co-operation means more teamwork between public and private sectors is vital, says Mark Tierney, chief executive of cross-industry collaboration Stop Scams UK.
“Combating fraud requires co-ordinated action across government and industry to stay ahead of these evolving threats — including the use of AI as a tool for good, to detect and disrupt harmful activity,” he says.
Miller at Cifas echoes that, calling for “a rapid exchange of information at scale” between financial services companies and the tech platforms where many scams start.
“We need to become far more literate as a society about [how] LLMs can circumvent safeguards — consumers need to have far greater scepticism,” he adds.
Dilley agrees, reflecting that moving towards distrust of anything seen online is, perhaps, not a bad thing.
You don’t have permission to access “http://www.spglobal.com/energy/en/news-research/latest-news/crude-oil/022726-mexican-crude-exports-fall-to-record-low-domestic-refining-holds-government-data” on this server.
The Ministry of Finance released its Monthly Economic Update and Outlook Report, stating that the number of people going abroad for employment has increased by 19 per cent.
According to the report, 75,663 workers registered for overseas employment in January, compared to 63,559 in January last year. The report says economic growth prospects have improved, citing enhanced macroeconomic stability and reduced inflationary pressures.
The Ministry of Finance also stated that a Rs38 billion Ramazan relief package was provided to the public. Inflation is expected to remain between 6 and 7 per cent this month. In January 2026, the inflation rate was recorded at 5.8 per cent.
However, geopolitical uncertainty and fluctuations in global commodity prices have been identified as potential risks. It said the balance between government revenues and expenditures has improved. The current account deficit remains under control, and the rupee has stayed stable.
IT exports increased, and access to cheaper financing has eased business activity. Large-scale manufacturing recorded a 4.8 per cent improvement over the past six months.
During the first seven months of the fiscal year, remittances increased by 11.3 per cent, reaching $23.2 billion from July to January. During the same period, exports declined by 5.5 per cent to $8.3 billion.
Treatment with PALYNZIQ led to statistically significant blood phenylalanine (Phe) lowering compared to diet alone in pivotal Phase 3 PEGASUS study
PALYNZIQ is the only enzyme substitution therapy approved for the treatment of people with PKU
SAN RAFAEL, Calif., Feb. 27, 2026 /PRNewswire/ — BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application (sBLA) for PALYNZIQ® (pegvaliase-pqpz) to include pediatric patients 12 years of age and older with phenylketonuria (PKU). PALYNZIQ is the only enzyme substitution therapy approved to reduce blood phenylalanine (Phe) concentrations in people with PKU.
“Adolescence is a period of increasing independence and academic demands, and represents a particularly challenging time for individuals with PKU. The ultra-restrictive diet required for PKU management may become unsustainable, and poor blood Phe control leads to adverse neurocognitive outcomes. PALYNZIQ is the only genotype-independent medication which may bring Phe into the normal range while allowing an unrestricted diet,” said Stephanie Sacharow, M.D., Director, Dr. Harvey Levy Program for PKU and Related Conditions, Boston Children’s Hospital. “In my clinic we have found that PALYNZIQ treatment adherence is even more successful in teens under age 18, while they are living at home with family support, and this approval allows us to extend this therapeutic option to adolescents who may benefit most.”
The FDA approval is based on data from PEGASUS, a Phase 3 multi-center open-label randomized controlled study evaluating the safety and efficacy of PALYNZIQ compared to diet alone in adolescents aged 12 to <18 with PKU who had uncontrolled blood Phe concentrations greater than 600 µmol/L on existing management. Individuals in the PALYNZIQ arm showed a significant mean reduction from baseline in blood Phe levels at Week 72 compared to those in the diet only arm (Table 1).
Table 1: Change from Baseline in Blood Phe Level (by μmol/L) Among Randomized Participants in PEGASUS
Study Visit
PALYNZIQ
Diet Only
Baseline
N = 36
N = 19
Mean (standard deviation [SD])
1025 (254)
1029 (199)
Week 72
N = 32
N = 17
Mean (SD)
567 (396)
973 (234)
Mean (SD; min, max) Change at Week 72
-473 (285; -22, -1133)
-19 (249; 355, -634)
Treatment Difference (95% CI)
-409 (-579, -240)
“Today’s FDA approval for PALYNZIQ is an important step forward for the PKU community, providing a new option for adolescents ages 12 and older that has the potential to improve daily PKU management,” said Catherine Warren, Executive Director of the National PKU Alliance. “Adolescence is a time of major change for people living with PKU, and having PALYNZIQ available better sets teenagers up for success with managing their blood phenylalanine levels as they navigate the transition into adulthood.”
As was recently presented at the 15th International Congress of Inborn Errors of Metabolism, by the end of Part 1 almost half of participants (44.4%) reached levels below guideline recommendations. Of those individuals, 75% were below 120 µmol/L and their average Phe reduction was 828 µmol/L (94% reduction in blood Phe from baseline). Nine participants whose blood Phe levels were below 30 µmol/L (hypophenylalaninemia) were able to increase their intact protein intake by 318.1% from baseline (SD=195.4; min=1.42, max=542.5) and decrease their intake of medical food protein by 55.16% (SD=56.4; min=-100, max=60.3); six individuals discontinued medical food completely.
The most common adverse reactions (≥20%) with PALYNZIQ in adolescents were injection site reactions, arthralgia, headache, pyrexia, hypersensitivity reactions, dizziness, nausea, vomiting, fatigue and pain in extremity. As in previous clinical studies, the overall safety profile of PALYNZIQ observed in adolescents showed most reactions occurring in the induction/titration phase and decreasing in frequency during the maintenance phase.
“Over the past two decades, BioMarin has been working hand-in-hand with the medical and advocacy communities to improve the lives of people living with PKU, including introduction of the first two treatment options for this inherited metabolic condition that otherwise requires lifelong adherence to a rigid medical diet,” said Greg Friberg, M.D., Executive Vice President and Chief Research & Development Officer at BioMarin. “We are proud to build on this legacy by expanding PALYNZIQ’s approval to adolescents as young as age 12, which will allow even more people with PKU the prospect of achieving substantially lower Phe levels.”
The company is also seeking approval from the European Medicines Agency with the goal of expanding treatment with PALYNZIQ to include adolescents as young as age 12 in the European Union.
Dr. Stephanie Sacharow has participated in speaking engagements and served on advisory boards for BioMarin.
About PALYNZIQ
PALYNZIQ substitutes the deficient phenylalanine hydroxylase (PAH) enzyme in PKU with a PEGylated version of the enzyme phenylalanine ammonia lyase to break down Phe. PALYNZIQ is administered using a dosing regimen designed to facilitate tolerability; PALYNZIQ’s safety profile consists primarily of immune-mediated responses, which can include anaphylaxis, for which robust risk management measures effective in clinical trials are in place.
See the full Prescribing Information, which includes a Boxed Warning. PALYNZIQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the PALYNZIQ REMS, because of the risk of anaphylaxis. Further information, including a list of qualified pharmacies, is available at www.PALYNZIQREMS.com or by telephone 1-855-758-REMS (1-855-758-7367).
PALYNZIQ is approved for the treatment of PKU in more than 35 countries worldwide.
Patient Support Accessing PALYNZIQ
To reach a BioMarin RareConnections® Case Manager, please call, toll-free, 1-866-906-6100 or e-mail [email protected]. For more information about PALYNZIQ, please visit www.palynziq.com. For additional information regarding this product, please contact BioMarin Medical Information at [email protected].
About Phenylketonuria
PKU, or phenylalanine hydroxylase (PAH) deficiency, is a genetic condition affecting approximately 70,000 people in the regions of the world where BioMarin operates. The PAH enzyme is required for the metabolism of Phe, an essential amino acid found in most protein-containing foods. If functional enzyme is not present in sufficient quantities, Phe accumulates to abnormally high levels in the blood and becomes toxic to the brain, resulting in a variety of complications including severe intellectual disability, seizures, tremors, behavioral problems and psychiatric symptoms.
As a result of newborn screening efforts implemented in the 1960s and early 1970s, virtually all individuals with PKU born after this period in countries with newborn screening programs are diagnosed at birth and treatment is implemented soon after.
PKU can be managed with a severe Phe-restricted diet, supplemented by low-protein modified foods and Phe-free medical foods; however, it is difficult for most individuals to adhere to this strict diet to the extent needed to achieve adequate control of blood Phe levels. Dietary control of Phe in childhood can prevent major developmental issues and neurological consequences, but poor Phe control in adolescence and adulthood is associated with a range of neuropsychological deficits and functional impairment.
PALYNZIQ U.S. Indication and Important Safety Information
PALYNZIQ® (pegvaliase-pqpz) is a phenylalanine (Phe)-metabolizing enzyme indicated to reduce blood Phe concentrations in adult and pediatric patients 12 years of age and older with phenylketonuria (PKU) who have uncontrolled blood Phe concentrations greater than 600 micromol/L (10 mg/dL) on existing management.
BOXED WARNING: ANAPHYLAXIS
Anaphylaxis has been reported after administration of PALYNZIQ and may occur at any time during treatment.
Administer the initial dose of PALYNZIQ under the supervision of a healthcare provider equipped to manage anaphylaxis, and closely observe patients for at least 60 minutes following injection. Prior to self-injection, confirm patient’s and observer’s (if applicable) ability to recognize signs and symptoms of anaphylaxis and to administer epinephrine, if needed.
Consider having an adult observer for patients who may need assistance in recognizing and managing anaphylaxis during PALYNZIQ treatment. If an adult observer is needed, the observer should be present during and for at least 60 minutes after PALYNZIQ administration, should be able to administer epinephrine, and call for emergency medical support upon its use.
Prescribe epinephrine for all patients treated with PALYNZIQ. Prior to the first dose, instruct the patient and observer (if applicable) on its appropriate use. Instruct the patient to seek immediate medical care upon its use. Instruct patients to carry epinephrine with them at all times during PALYNZIQ treatment.
PALYNZIQ is available only through a restricted program called PALYNZIQ REMS (Risk Evaluation and Mitigation Strategy). Further information, including a list of qualified pharmacies, is available at PALYNZIQREMS.com or by telephone at 1-855-758-REMS (1-855-758-7367).
WARNINGS AND PRECAUTIONS
Anaphylaxis
Signs and symptoms of anaphylaxis reported include syncope, hypotension, hypoxia, dyspnea, wheezing, chest discomfort/chest tightness, tachycardia, angioedema (swelling of face, lips, eyes, tongue), throat swelling or tightness, flushed or red skin, rash, urticaria, pruritus, and gastrointestinal symptoms (vomiting, nausea, diarrhea).
Anaphylaxis generally occurred within 1 hour after injection; however, delayed episodes occurred up to 48 hours after PALYNZIQ administration.
Consider the risks and benefits of readministering PALYNZIQ following an episode of anaphylaxis. If the decision is made to readminister PALYNZIQ, administer the first dose under the supervision of a healthcare provider equipped to manage anaphylaxis and closely observe the patient for at least 60 minutes following the dose.
In clinical trials of primarily adult patients with an induction/titration/maintenance dosage regimen, 29/285 (10%) experienced a total of 42 anaphylaxis episodes.
In a clinical trial of patients 12 to less than 18 years of age, 4/36 (11%) of PALYNZIQ-treated patients experienced 1 episode of anaphylaxis.
Other Hypersensitivity Reactions
Management of hypersensitivity reactions should be based on the severity of the reaction, recurrence of the reaction, and the clinical judgment of the healthcare provider.
In clinical trials of primarily adult patients taking PALYNZIQ, hypersensitivity reactions, other than anaphylaxis, were reported in 204/285 (72%) of patients. In a clinical trial of patients 12 to less than 18 years old taking PALYNZIQ, these reactions were reported in 12 out of 36 (33%) of patients.
Injection Site Infections
Serious injection site infections including abscess, cellulitis, necrosis, and ulcer have been reported. Some cases required hospitalization, surgical debridement, intravenous antibiotics, and discontinuation of PALYNZIQ.
Provide proper training to patients and/or caregivers on the use of aseptic injection technique, injection site rotation and to check the site for redness, swelling, or tenderness. Instruct patients to contact their healthcare provider if signs or symptoms of an infection develop, persist, or worsen.
Hypophenylalaninemia (HypoPhe) Some patients have experienced HypoPhe; monitor blood Phe levels periodically during treatment. Frequent blood Phe monitoring is recommended in the pediatric population. For blood Phe concentrations below 30 micromol/L, the dosage of PALYNZIQ may be reduced and/or dietary protein and Phe intake may be modified to maintain blood Phe concentrations within a clinically acceptable range and above 30 micromol/L.
ADVERSE REACTIONS The most common adverse reactions in clinical trials of primarily adult patients (at least 20% in either treatment phase) were injection site reactions, arthralgia, hypersensitivity reactions, headache, generalized skin reactions lasting at least 14 days, nausea, abdominal pain, vomiting, cough, oropharyngeal pain, pruritus, diarrhea, nasal congestion, fatigue, dizziness, and anxiety.
Arthralgia: In clinical trials, 245 out of 285 (86%) primarily adult patients experienced episodes consistent with arthralgia (includes back pain, musculoskeletal pain, pain in extremity, and neck pain).
Injection sitereactions were reported as early as after the first dose of PALYNZIQ and occurred at any time during treatment.
Generalized Skin Reactions: In clinical trials, 134 out of 285 (47%) primarily adult patients treated with PALYNZIQ experienced generalized skin reactions (not limited to the injection site) lasting at least 14 days.
Angioedema and serum sickness: In clinical trials, 22 out of 285 (8%) primarily adult patients experienced 45 episodes of angioedema (symptoms included: pharyngeal edema, swollen tongue, lip swelling, mouth swelling, eyelid edema, and face edema) occurring independent of anaphylaxis. In clinical trials, serum sickness was reported in 7 out of 285 (2%) primarily adult patients.
In the clinical trials, adverse reactions were associated with treatment discontinuation, dosage reduction and temporary drug interruption. In the 285 primarily adult patients exposed to PALYNZIQ in an induction/titration/maintenance regimen in clinical trials, 44 (15%) patients discontinued treatment due to adverse reactions.
Pediatric Patients: In a clinical study of 55 patients aged 12 to less than 18 years of age, the most common adverse reactions (at least 20% and greater than in control) were injection site reactions, arthralgia, headache, pyrexia, hypersensitivity reactions, dizziness, nausea, vomiting, fatigue, and pain in extremity. Two patients (5.6%) discontinued treatment due to adverse reactions.
Blood Phenylalanine Monitoring and Diet
Obtain blood Phe concentrations every 4 weeks until a maintenance dosage is established. Periodically monitor blood Phe concentrations during maintenance therapy.
Counsel patients to monitor dietary protein and Phe intake, and adjust as directed by their healthcare provider.
DRUG INTERACTIONS
Effect of PALYNZIQ on Other PEGylated Products
In a single-dose study of PALYNZIQ in adult patients with PKU, two patients receiving concomitant injections of medroxyprogesterone acetate suspension (a formulation containing PEG 3350) experienced a hypersensitivity reaction. One of the two patients experienced anaphylaxis
The clinical effects of concomitant treatment with different PEGylated products are unknown. Monitor patients treated with PALYNZIQ and concomitantly with other PEGylated products for hypersensitivity reactions including anaphylaxis
USE IN SPECIFIC POPULATIONS
Pregnancy and Lactation Available data do not establish an increased risk of adverse developmental outcomes to the fetus exposed to PALYNZIQ.
Advise women who are exposed to PALYNZIQ during pregnancy or who become pregnant within one month following the last dose of PALYNZIQ that there is a pregnancy surveillance program that monitors pregnancy outcomes. Healthcare providers should report PALYNZIQ exposure and encourage these patients to report their pregnancy to BioMarin (1-866-906-6100).
Monitor blood Phe levels in breastfeeding women treated with PALYNZIQ to ensure maintenance of blood Phe <360 micromol/L. Adjust dosage and/or dietary protein and Phe intake as needed to avoid concentrations below 30 micromol/L.
Pediatric & Geriatric Use: The safety and effectiveness of PALYNZIQ in pediatric patients from birth to less than 12 years have not been established. Clinical studies of PALYNZIQ did not include patients aged 65 years and older.
You are encouraged to report suspected adverse reactions to BioMarin at 1-866-906-6100, or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see accompanying full Prescribing Information, including Boxed Warning.
About BioMarin
BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with eight commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients. To learn more, please visit www.biomarin.com.
Forward-Looking Statements
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including without limitation, statements about: the approval of BioMarin’s supplemental Biologics License Application (sBLA) for PALYNZIQ for adolescents 12 years of age and older with phenylketonuria (PKU) by the U.S. Food and Drug Administration (FDA), including the safety profile and potential benefits of PALYNZIQ for adolescents and the potential to fundamentally change the way adolescents manage PKU in their daily lives; BioMarin’s work with the European Medicines Agency (EMA) with the goal of expanding treatment with PALYNZIQ to include adolescents as young as age 12 in the European Union; and the continued clinical development of PALYNZIQ. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others, results and timing of current and planned preclinical studies and clinical trials of PALYNZIQ; any potential adverse events observed in the continuing monitoring of the patients in the clinical trials; the content and timing of decisions by the FDA, the EMA, the European Commission and other regulatory authorities, and those factors detailed in BioMarin’s filings with the Securities and Exchange Commission (SEC), including, without limitation, the factors contained under the caption “Risk Factors” in BioMarin’s Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated by any subsequent filings with the SEC. Investors are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.
BioMarin®, BioMarin RareConnections® and PALYNZIQ® are registered trademarks of BioMarin Pharmaceutical Inc.
