Category: 3. Business

KEYNOTE-905/EV-303 (NCT03924895), a phase 3, open-label, randomized trial, evaluated perioperative enfortumab vedotin (EV) plus pembrolizumab (pembro) compared with surgery alone in patients with muscle-invasive bladder cancer (MIBC) who were ineligible for or declined cisplatin-based chemotherapy.

Presented by Prof. Christof Vulsteke at the ESMO Congress 2025, the study demonstrated that adding EV + pembro to radical cystectomy with pelvic lymph node dissection resulted in significant improvements in event-free survival (EFS), overall survival (OS), and pathologic complete response (pCR). These findings mark a major advance for cisplatin-ineligible MIBC, establishing a potential new perioperative standard of care.

Background

Radical cystectomy with pelvic lymph node dissection (RC + PLND) remains the standard of care for patients with muscle-invasive bladder cancer. However, nearly half of these patients are ineligible for cisplatin-based chemotherapy due to renal dysfunction, frailty, or comorbidities, leaving a substantial population without effective perioperative options.

Previous studies have shown limited benefit from surgery alone in this setting, underscoring the unmet need for alternative strategies. Enfortumab vedotin, an antibody–drug conjugate targeting Nectin-4, combined with pembrolizumab, has demonstrated potent antitumor activity and a favorable safety profile in metastatic urothelial cancer, providing a strong rationale for evaluation in the perioperative context.

Methods

KEYNOTE-905/EV-303 is a randomized, open-label, phase 3 trial that enrolled adults with MIBC (T2–T4aN0M0 or T1–T4aN1M0) who were cisplatin-ineligible per Galsky criteria or declined cisplatin.
Participants were randomized 1:1 to receive:

• EV + pembro arm: Three cycles of EV (1.25 mg/kg on days 1 and 8) plus pembrolizumab (200 mg every three weeks) before RC + PLND, followed by six additional EV cycles and 14 cycles of pembrolizumab postoperatively.
• Control arm: RC + PLND alone, with adjuvant nivolumab permitted when clinically indicated.

The primary endpoint was event-free survival (EFS) by blinded independent central review (BICR).Key secondary endpoints included overall survival (OS), pathologic complete response (pCR), and safety.

Timeline of study development:

• The study initiated in 2019 with two treatment arms—perioperative pembrolizumab + RC + PLND vs RC + PLND alone—randomized 1:1.
• In 2020, a third arm was added, introducing perioperative EV + pembro + RC + PLND, changing the randomization to 1:1:1.
• By 2022, the design evolved: the pembrolizumab-alone arm was discontinued, and randomization was updated to 1:1 between EV + pembro + RC + PLND (EV + pembro arm) and RC + PLND (control arm).
• The inclusion criteria were expanded to include patients who were cisplatin-eligible but declined cisplatin, broadening the real-world relevance of the study population.
• Adjuvant nivolumab was permitted in the control arm per local guidelines.

Results

A total of 344 participants were randomized between December 2020 and June 2024 (170 to EV + pembro; 174 to control). Over 80% were cisplatin-ineligible, and the median follow-up was 25.6 months (range 11.8–53.7).The combination regimen produced statistically significant and clinically meaningful improvements across all efficacy endpoints:

• Event-Free Survival (EFS): Median EFS was not reached with EV + pembro versus 15.7 months with control (HR 0.40; 95% CI 0.28–0.57; P<0.0001). At one years, EFS rates were 77.8% vs 55.1%, respectively and at two years, 74,7% vs 39,4%

• Overall Survival (OS): Median OS was not reached with EV + pembro versus 41.7 months with control (HR 0.50; 95% CI 0.33–0.74; P=0.0002). The 12-month OS rates were 86.3% vs 75.7%, and the 24-months OS rates were 79,7% vs 63,1%

• Pathologic Complete Response (pCR): 57.1% with EV + pembro vs 8.6% with control, an absolute difference of 48.3% (95% CI 39.5–56.5; P<0.0001).

 

Safety:

Treatment-emergent adverse events (TEAEs) occurred in nearly all patients (100% in EV + pembro vs 64.8% in control). Grade ≥3 events were reported in 71.3% and 45.9%, respectively. The most frequent grade ≥3 adverse events of special interest were severe skin reactions (11.4%) related to pembrolizumab and cutaneous toxicity (10.8%) associated with enfortumab vedotin.

Despite the high incidence of AEs, the safety profile remained manageable and consistent with prior studies, and no new safety signals were identified.

Conclusions

The KEYNOTE-905/EV-303 trial demonstrated that adding perioperative enfortumab vedotin plus pembrolizumab to standard surgery significantly improved event-free survival, overall survival, and pathologic complete response rates in patients with cisplatin-ineligible MIBC.

These findings establish EV + pembrolizumab as the first perioperative regimen to improve outcomes versus RC + PLND alone in this population, offering a potential new standard of care.

 

You can read the full abstract here.

Red Cat Holdings, Inc. (NASDAQ:RCAT) is one of the stocks Jim Cramer was focused on recently. When a caller asked about the stock during the lightning round, Cramer said:

“Okay, so this is a Ben Stoto favorite, not really. It’s a drone company. We are on the fence about buying drone companies that aren’t making money.”

Pixabay/Public Domain

Red Cat Holdings, Inc. (NASDAQ:RCAT) develops drone systems and control technologies for military, government, and commercial use. During the February 18 episode, Cramer mentioned the stock and remarked:

“This one just happens to be a personal favorite of our chief scientist, Ben Stoto. We talk about Red Cat a lot. It’s a data analytics company, and you know what? I’m going to tell you, you can buy it. You really can. Because if it doubled, you’d feel like an idiot for not buying Red Cat.”

It is worth noting that since the above comment was made, the company’s stock gained around 65%.

While we acknowledge the potential of RCAT as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you’re looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock.

READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now.

Disclosure: None. This article is originally published at Insider Monkey.

Futu Holdings (NasdaqGM:FUTU) shares have seen a steady climb this year, with the stock up over 100% year-to-date. Many investors are now reviewing its recent performance and growth numbers for insights into what might come next.

See our latest analysis for Futu Holdings.

Futu Holdings has enjoyed sustained momentum, with a 105.8% year-to-date share price return. This reflects renewed investor confidence and optimism around its growth story. Over the past year, its total shareholder return reached 79.4%, underscoring long-term performance beyond just recent gains.

If you’re weighing what else might be showing breakout momentum, this is a great moment to broaden your search and discover fast growing stocks with high insider ownership

With shares surging so impressively, the central question becomes whether Futu Holdings is still undervalued at current levels, or if the market is already accounting for the company’s future growth potential and leaving little room for upside.

Compared to Futu Holdings’ last close price of $163.53, the most widely followed narrative estimates a fair value of $207.27. The picture that emerges is of a company with catalysts that some see as transformative, and a valuation that challenges the market’s current view.

The rapid growth in funded accounts, especially from international markets such as Singapore, the U.S., Malaysia, and Japan, signals ongoing global expansion and diversification of Futu’s user base. This positions the company to capture rising middle-class wealth and digital financial adoption in Asia, supporting long-term revenue and AUM growth.

Read the complete narrative.

What is driving that bold upside call? This narrative is built on expectations of relentless customer growth, a resilient business model, and margin strength usually reserved for industry leaders. The surprising mix of ambitious projections and global expansion creates a valuation thesis you will not want to miss.

Result: Fair Value of $207.27 (UNDERVALUED)

Have a read of the narrative in full and understand what’s behind the forecasts.

However, risks remain, as heightened competition in key Asian markets and regulatory hurdles could quickly turn investor optimism into caution for Futu Holdings.

Find out about the key risks to this Futu Holdings narrative.

While many focus on analyst price targets, compare Futu Holdings’ current price-to-earnings ratio of 22.4x against the industry average of 25.4x and a peer average of 22.2x. However, the fair ratio for Futu is estimated at 21.4x, suggesting that shares could be slightly expensive. This is an important detail for those weighing potential returns or risks.

See what the numbers say about this price — find out in our valuation breakdown.

If the narrative above doesn’t reflect your perspective, why not take a closer look at the figures yourself and craft your own in just a few minutes using Do it your way

A good starting point is our analysis highlighting 3 key rewards investors are optimistic about regarding Futu Holdings.

Don’t let great opportunities pass you by. Expand your watchlist with high-potential stocks you may have missed. Use these targeted screens to stay one step ahead:

This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Companies discussed in this article include FUTU.

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

Few car buyers have heard of Nexperia. But this Dutch company makes chips that are essential for making cars — and now, it’s at the center of a trade dispute that could shutter global auto plants and send already-record-level car prices even higher.

The dispute is just one part of wider trade tensions between the United States and China. The Nexperia saga began in earnest this past December when the US Commerce Department put Nexperia’s parent company, China-based Wingtech Technologies, on a list of companies facing trade restrictions.

Then, this October, China’s Ministry of Commerce banned Nexperia China and its subcontractors from exporting specific finished components and sub-assemblies manufactured in China. The Dutch government took control of Nexperia following this move.

The tensions have prompted concerns of possible auto plant shutdowns, since the chips Nexperia makes are critical to the assembly of the cars and trucks in which they’re installed. The fear is that the trade dispute could halt Nexperia’s production of the chips, and it would be difficult to replace them.

When and if auto plants might be forced to halt operations is not clear. But a similar chip shortage following the pandemic caused temporary plant shutdowns and the supply of new autos to drop significantly for more than a year. That shortage in turn helped drive up the price of both new and used cars.

Vehicles have become more dependent on computer chips, transistors and diodes on everything from adjusting driver’s seats to feeding the proper amount of fuel into engines and providing braking power. Vehicles can’t be completed if those critical components are unavailable.

While Nexperia is little known outside the industry, its site says the company has more than 6,000 products qualified for use in automobiles, and shipments of 110 billion of its products annually. It has 12,500 employees across Europe, Asia and the United States. It said it’s working on business continuity plans and is “confident that a solution will be found.”

But automaker trade groups are less confident and have sounded the alarm of possible auto plant shutdowns.

“If the shipment of automotive chips doesn’t resume – quickly – it’s going to disrupt auto production in the U.S. and many other countries and have a spillover effect in other industries,” John Bozzella, CEO of the Alliance for Automotive Innovation, a lobbying group for most major automakers, said in a statement. “It’s that significant. We’re urging a quick resolution, so U.S. and global automaking remains on track.”

The European Automobile Manufacturers Association said it would take months to get new supplies of the components its members have been getting from Nexperia, while the supply of its chips is expected to last only weeks.

“Automakers have taken steps over the last years to diversify supply chains but risk cannot be mitigated down to zero. This is a cross-industry issue affecting a large number of suppliers and virtually all of our members,” Sigrid de Vries, director general of the European associations, said in a statement.

“We suddenly find ourselves in this alarming situation,” she added. We really need quick and pragmatic solutions from all countries involved.”

Nexperia make about 40% of the automotive chips in the segment of the market that includes transistors and diodes, according to Ian Riches, vice president of the global automotive practice for research firm TechInsights.

Automakers are already being forced to deal with increased costs due to tariffs being imposed by the Trump administration. While many are absorbing the costs so far, Kelley Blue Book came out with an estimate last week that the average US new car price just topped $50,000 for the first time.

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AstraZeneca, Daiichi Sankyo and Gilead have made big advances in treating the hardest-to-tackle type of breast cancer, boosting prospects for tens of thousands of patients a year.

The drugmakers are unveiling trial results for existing blockbuster drugs in “triple negative” breast cancer — so-called because it is not one of the three main types. These include the first ever study showing a medicine can extend the life of patients who cannot be treated with immunotherapy drugs, the majority of triple negative cases.

Patients with triple negative breast cancer make up about 10 per cent to 20 per cent of people diagnosed. Breast cancer is the most common type of the disease in the UK, and the second most common after skin cancer in the US.

AstraZeneca and Japanese pharma company Daiichi’s drug Datroway improved overall survival for patients by 23 per cent, and increased the time they lived without the cancer getting worse by 43 per cent, compared with those treated with chemotherapy.

David Frederickson, executive vice-president for oncology at AstraZeneca, said the results showed an “outstanding opportunity” to expand treatment to more patients. The company has had 10 positive late-stage trial results in oncology this year, five of which have been in breast cancer.

“It’s been an exceptional year,” he said. “The breast cancer studies alone have the opportunity to reach nearly half a million patients.”

Frederickson added AstraZeneca’s oncology sales rose 16 per cent year-on-year in the first half and he hopes they will contribute half of the company’s goal of $80bn of sales by 2030.

AstraZeneca and Daiichi also announced positive trial results for their Enhertu breast cancer drug in earlier-stage patients. The treatment is approved for later-stage patients but it is not available on the NHS in England, even though it is in many other countries including Scotland.

One of two Enhertu studies found a three-year disease-free survival rate of 92 per cent, compared with 84 per cent with the most commonly used drugs.

Fredrickson said there needs to be a “modernisation” of NHS methodologies, including valuing the end of life more, to ensure patients can get access.

The results were presented at the European Society for Medical Oncology this weekend, where US drugmaker Gilead also reported positive results for its cancer drug Trodelvy in patients with triple negative breast cancer.

Trodelvy, which is already approved for breast cancer, reduced the risk of cancer progression or death by 38 per cent versus other forms of chemotherapy. Survival rates were extended with the drug to 9.7 months versus 6.9 months for chemotherapy, the company said.

Trodelvy generated $657mn for Gilead in the first six months of 2025, up 5 per cent from the same period last year. Oncology accounts for about 12 per cent of the company’s sales.

The latest data for Trodelvy marks a bounceback for the drug. A year ago, Gilead withdrew it for certain urinary tract cancers after it failed a drug trial.

Eli Lilly also reported encouraging data. Its Verzenio drug prolonged survival for certain high-risk early breast cancers by 15.8 per cent versus conventional treatments. It is the first therapy in more than two decades to demonstrate a significant overall survival benefit in certain, high-risk early breast cancers.

Representative image
| Photo Credit: Getty Images/iStockphoto

With US stock prices reaching new record highs, the Warren Buffett Indicator has reached an alarming 218%. As a reminder, when it rises above 160% it’s historically suggested that US stocks are significantly overvalued.

This isn’t the only signal hinting that valuations might be getting stretched in 2025. And yet, despite rising concerns, the ’Oracle of Omaha’ and his team are still buying some US shares.

So what stocks is the billionaire investor buying? And should investors follow in his footsteps?

With a reputation for being a value-oriented investor, the fact that Buffett’s buying at a time when valuations are high seems strange, on the surface. But digging deeper, he’s actually still executing the same tried and tested strategy of prioritising value at a fair price.

Two of his recent investments in Nucor (NYSE:NUE) and UnitedHealth Group (NYSE:UNH) seem to demonstrate this perfectly.

So what do these businesses do? And why is Buffett’s team buying them now?

Nucor is a US steel producer. In fact, it’s one of the largest in the country, operating an expansive network of furnaces that recycle scrap metal into quality steel. This unique approach drastically reduces the cost of manufacturing, giving the group a notable competitive edge over its US rivals – something Buffett loves to see.

With the US imposing a 50% tariff on imported steel, Nucor now looks far more attractive to steel consumers. And when combined with surging steel demand courtesy of artificial intelligence (AI) infrastructure and national electrification spending, the business looks like it could be a new champion within the supply chain of countless US-based businesses.

Combining this with an undemanding forward price-to-earnings ratio of 12.2, it’s not so surprising that Buffett‘s taken an interest.

Of course, there are still risks. Even with tariffs, steel demand remains highly cyclical and sensitive to activity within the construction and industrials sectors.

Since higher interest rates often subdue activity within these industries, Nucor’s growth could prove lacklustre, especially if inflation continues to prove sticky. And if AI infrastructure spending starts to slow, the firm could lose a significant tailwind that’s currently driving it forward.

UnitedHealth’s also another seemingly cyclical strategy the billionaire’s pursuing. The firm’s the largest health insurance provider in the US. And with an ageing population, demand for its services is suspected to steadily trend upward.

That’s potentially great news for shareholders, given that UnitedHealth’s business model is both high-margin and cash-generative. However, given its leading role within the US healthcare (a sector that’s becoming increasingly scrutinised), the company has been getting a lot of attention from regulators.

The Department of Justice is already investigating the firm for anti-competitive practices. And with political pressure to curb healthcare costs, management’s long-term pricing power may be restricted. This, among other factors, is one of the reasons why UnitedHealth shares have tumbled close to 40% in the last 12 months.

For both Nucor and UnitedHealth, Buffett’s bullish stance makes a lot of sense given the long-term opportunities at seemingly reasonable valuations. Therefore, I think it’s wise for investors to dig a bit deeper and see whether or not these US stocks could be a good fit for their own portfolios.

The post With stock prices at record highs, Warren Buffett’s been buying these shares! appeared first on The Motley Fool UK.

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Zaven Boyrazian has no position in any of the shares mentioned. The Motley Fool UK has no position in any of the shares mentioned. Views expressed on the companies mentioned in this article are those of the writer and therefore may differ from the official recommendations we make in our subscription services such as Share Advisor, Hidden Winners and Pro. Here at The Motley Fool we believe that considering a diverse range of insights makes us better investors.

Motley Fool UK 2025

Samsung Electronics (KOSE:A005930) shares have been on a strong run, delivering a 21% gain over the past month with year-to-date returns approaching 83%. Investors are watching closely for hints of what might fuel its next move.

See our latest analysis for Samsung Electronics.

After surging nearly 22% in the last month, Samsung Electronics is riding a wave of renewed optimism, with its share price building strong momentum this year. Notably, the 12-month total shareholder return sits at 69%, outperforming many global peers and reinforcing a sense that market confidence in Samsung’s strategy and growth prospects is picking up.

If Samsung’s run has you thinking about what else could be on the rise, now is the perfect time to discover See the full list for free.

With shares already up sharply and optimism running high, the big question is whether Samsung is still trading at an attractive value or if the market has already priced in its next chapter of growth. Could this be a real buying opportunity?

Samsung Electronics’ most popular narrative suggests its shares still trade below a fair value estimate, compared with the most recent close. This sets up a compelling contrast between strong recent returns and the valuation outlook that follows.

Leadership in advanced semiconductor technologies and high-performance memory is driving customer wins, higher margins, and expanding Samsung’s presence in new and existing markets. Diversification into premium products, AI-powered devices, and high-margin sectors is supporting resilient profitability and reducing revenue cyclicality.

Read the complete narrative.

Want to know what bold forecasts are hiding behind this bullish price tag? The narrative hints at strong growth assumptions, shifting margins, and future profits more typical for market leaders. Uncover which aggressive projections are setting the bar for Samsung’s ambitious fair value. Dive into the full narrative to see what could be driving the optimism.

Result: Fair Value of ₩105,207 (UNDERVALUED)

Have a read of the narrative in full and understand what’s behind the forecasts.

However, persistent geopolitical tensions or tougher competition in semiconductors could disrupt Samsung’s stride. This could make the bullish outlook more challenging to achieve.

Find out about the key risks to this Samsung Electronics narrative.

While one method suggests Samsung is undervalued, its current price-to-earnings ratio stands at 22.8 times, higher than the peer average of 19.7 times but just below the broader Asian tech industry’s 23.4 times. The fair ratio estimate sits at 31.6 times, hinting there is room to run if the market agrees with optimistic growth assumptions. Are investors willing to pay up, or is caution about competition and future growth starting to creep in?

See what the numbers say about this price — find out in our valuation breakdown.

If you see things differently or want to dig deeper into the numbers, you can build your own Samsung Electronics story in just a few minutes. Do it your way

A good starting point is our analysis highlighting 3 key rewards investors are optimistic about regarding Samsung Electronics.

Smart investors always hunt for fresh opportunities before everyone else. Don’t sit on the sidelines when new trends and high-potential stocks could be in your hands.

This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Companies discussed in this article include 005930.

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

When Maheen found a brand-new Dyson Airwrap for the bargain price of £260 on the resale website Vinted, she was thrilled. The seller’s reviews were all five-star, and she trusted in the buyer-protection policy should something go wrong.

Sold new, an Airwrap costs between £400 and £480, but Maheen did not suspect anything was amiss. “I had used Vinted many times and it was simple and straightforward. Nothing had ever gone wrong,” she says.

However, after two weeks – and about four uses – she spotted a problem. “I noticed the wire began to smoke and the product seemed unsafe,” she says. Maheen contacted Dyson and was told to send in the Airwrap.

Its response confirmed her fears. “I got a letter from [Dyson] confirming the product was counterfeit. It was unsafe and they wouldn’t return it to me,” she says.

Maheen’s experience is far from unique. Almost two-fifths (37%) of Britons have been scammed while buying or selling on online marketplaces such as Facebook Marketplace, eBay and Vinted, according to research from the credit reference agency Experian.

Victims of this type of crime tend to skew younger, with more than half of gen Z (58%) telling researchers they had been scammed compared with just 16% of people over the age of 55.

For almost a quarter of people losses were in the region of £51 to £100, while 13% had lost more than £250. A small number said the scam had cost them between £501 and £1,000.

The most common type of scam respondents encountered – being sent fake or counterfeit products (34%) – is the one Maheen fell prey to. Next up was requests to pay off-platform (31%), and items never arriving after payment (22%).

What the scam looks like

It looks like the legitimate item and the description suggests it is – more than half of scam victims (51%) told Experian they only realised they had been scammed once their item was delivered and turned out to be fake, or failed to arrive.

Photos may be low resolution or look too good – like a catalogue photo – because they have been taken from other websites.

The price will be less than you would expect and if you start asking questions the seller may try to rush you into a purchase and may ask you to pay them outside the Vinted platform.

What to do

Always review a seller’s profile closely and read customer reviews before purchasing an item on a marketplace. Try to obtain as much information about the product as possible before buying – for instance, ask the seller to send a video of the product. To protect yourself, stick to secure payment methods and avoid bank transfers.

If the worst happens, report the incident to the marketplace and ask for a refund. They may ask for screenshots of messages and the details of the seller or buyer, plus any bank transfer details.

Maheen was outside the Vinted two-day buyer protection window, but assumed she would get her money back because the product was dangerous. However, she found that it “was really hard to talk to someone”.

She says: “It felt like I was talking to a bot.”

With Guardian Money’s help, she has now got her money back.

A Vinted spokesperson said: “The vast majority of transactions on Vinted take place without issue, and our teams work hard to ensure a smooth trading experience for all our Vinted members.

“When a dispute does occur between a buyer and a seller, we will mediate, working closely with our delivery partners and potentially asking for additional information or evidence, before issuing a final decision.”

If appealing to the marketplace directly goes nowhere, there are other things you can do.

If you used a debit card ask your bank to make a chargeback claim. Alternatively, if you paid by credit card, try a section 75 claim – this is only an option if you have spent more than £100. If you paid by bank transfer it is more complicated, but you may be entitled to a refund under new fraud refund protections.