Category: 3. Business

Combining belantamab mafodotin-blmf (Blenrep) with dexamethasone and bortezomib (Velcade; BVd) demonstrated clinically meaningful and statistically significant improvements in outcomes like overall survival (OS) and progression-free survival (PFS) among patients with relapsed/refractory multiple myeloma, according to updated findings from the phase 3 DREAMM-7 trial (NCT04246047) published in Lancet Oncology.¹

The median OS was not reached (NR; 95% CI, NR-NR) with BVd and NR (95% CI, 41.0-NR) with daratumumab (Darzalex) plus bortezomib and dexamethasone (DVd; HR, 0.58; 95% CI, 0.43-0.79; P = .0002). In each respective arm, the 24-month OS rates were 79% (95% CI, 73%-84%) vs 67% (95% CI, 61%-73%), and the 36-month rates were 74% (95% CI, 68%-79%) vs 60% (95% CI, 54%-66%). Across prespecified subgroups, BVd demonstrated OS benefits in patients with prior exposure to lenalidomide (Revlimid), those with lenalidomide-refractory disease, and those with high-risk cytogenetics.

Data showed an objective response rate (ORR) of 83% (95% CI, 77.8%-87.6%) with BVd vs 71% (95% CI, 65.3%-76.8%) with DVd, with 36% (95% CI, 29.8%-42.2%) and 18% (95% CI, 13.0%-22.8%) in each arm achieving a complete response (CR) or better. Minimal residual disease (MRD) negativity occurred in 25% (95% CI, 19.8%-31.0%) and 10% (95% CI, 6.9%-14.8%) of patients with a CR or better, with sustained MRD-negative status for at least 12 months reported in 14% (95% CI, 10.2%-19.5%) and 4% (95% CI, 2.2%-7.7%) of patients with a CR or better. BVd produced a median duration of response (DOR) of 40.8 months (95% CI, 30.5-NR) vs 17.8 months (95% CI, 13.8-23.6) with DVd.

Regarding PFS2, which was defined as the time from randomization to disease progression following the initiation of any subsequent antimyeloma therapy or death from any cause, events occurred in 38% of the BVd arm and 50% of those in the DVd arm. Additionally, the median PFS2 was NR (95% CI, 45.6-NR) and 33.4 months (95% CI, 26.7-44.9) in each arm (HR, 0.59; 95% CI, 0.45-0.77).

“DREAMM-7 showed significant and clinically meaningful [OS], [PFS], [MRD] negativity, and [DOR] benefits with BVd compared with DVd. The safety profile of BVd was consistent with that in the primary analysis, with no new safety concerns,” lead study author Vania Hungria, MD, PhD, from the Department of Hematology at Clinica São Germano in São Paulo, Brazil, wrote with coauthors.¹ “To our knowledge, this is the first phase 3, randomised, head-to-head study showing such robust [OS] benefit with a triplet regimen against an established daratumumab-based regimen in patients with [relapsed/refractory multiple myeloma] who have received at least 1 previous line of therapy, further supporting the use of BVd as a potential new standard of care for these patients.”

In the open-label DREAMM-7 trial, 494 patients were randomly assigned to receive BVd (n = 243) or DVd (n = 251). Investigators administered belantamab mafodotin at 2.5 mg/kg intravenously every 3 weeks and daratumumab at 16 mg/kg intravenously once weekly in cycles 1 to 3, every 3 weeks in cycles 4 to 8, and every 4 weeks thereafter. Additionally, all patients received bortezomib at 1.3 mg/m² subcutaneously twice weekly for 8 cycles plus dexamethasone at 20 mg orally or intravenously on the day of and day after bortezomib.

The trial’s primary end point was PFS. Secondary end points included OS, MRD negativity in patients with a CR or better, DOR, and safety. Patients 18 years and older with a confirmed multiple myeloma diagnosis based on International Myeloma Working Group criteria, at least 1 prior line of treatment, documented disease progression on or after the most recent line of therapy, and an ECOG performance status of 0 to 2 were eligible for enrollment on the trial.

The median age was 64.5 years (IQR, 57.0-71.0) across both treatment groups, and most patients were male (55%) and White (83%). Overall, baseline characteristics were balanced across the BVd and DVd arms. The median follow-up at the time of this analysis was 39.4 months (range, 0.1-52.3).

Investigators noted receipt of any subsequent therapy in 36% of the BVd arm and 52% of the DVd arm. In each respective arm, the most common types of subsequent treatment included steroids (32% vs 43%), dexamethasone (31% vs 42%), and immunomodulators (25% vs 37%).

Any-grade adverse effects (AEs) affected 100% of the BVd and the DVd arms, with grade 3/4 toxicities occurring in 95% vs 78%. In each arm, 32% vs 19% had toxicities leading to treatment discontinuation, 75% vs 59% had AEs resulting in dose reductions, and 95% vs 76% had toxicities associated with dose delays. Investigators reported fatal serious AEs in 11% of the BVd arm and 8% of the DVd arm.

Thrombocytopenia was the most common grade 3/4 toxicity and occurred in 56% of the BVd arm compared with 35% of the DVd arm. The most common ocular toxicities in the BVd arm included dry eyes (53%), photophobia (50%), foreign body sensations in the eyes (46%), and eye irritation (45%).

In July 2025, the FDA’s Oncologic Advisory Drug Committee (ODAC) voted 5-3 against the favorability of BVd as a treatment for patients with multiple myeloma following at least 1 prior line of therapy.²

References

1. Hungria V, Robak P, Hus M, et al. Belantamab mafodotin plus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-7): updated overall survival analysis from a global, randomised, open-label, phase 3 trial. Lancet Oncol. Published online July 15, 2025. doi:10.1016/S1470-2045(25)00330-4
2. July 17, 2025, Meeting of the Oncologic Drugs Advisory Committee (ODAC). FDA. Streamed live July 17, 2025. Accessed July 23, 2025. https://tinyurl.com/mhafuuy8

Train passengers in the West of England have been warned to expect disruption on the railways on Sunday due to “crew availability”.

Great Western Railway (GWR) said fewer trains would run on a number of routes and that those that do run are likely to be busier.

Those travelling between Bristol Temple Meads and Gloucester or Bristol Temple Meads and Taunton should check their journeys before they travel.

Service between Westbury and Portsmouth or Weymouth may also be cancelled, and also those between Reading and Gatwick and Reading and Basingstoke.

GWR apologised for the disruption and said it would run a limited rail replacement bus service “where possible”, along some of the routes affected.

The company added that due to the complexity of updating timetable systems, journey planning apps are unlikely to show the changes until Sunday morning.

Those who have already booked a ticket but decide not to travel can claim a full refund from the GWR website.

By Mark Hulbert

How worrisome is the performance gap between the S&P 500 and the Russell 2000?

The Russell 2000 Index RUT has gone almost four years without hitting a new high. This benchmark for the small- and midcap sectors of the U.S. market peaked on Nov. 8, 2021. Now, two years into a bull market that has taken the larger-cap S&P 500 SPX to successive new highs, the Russell 2000 is about 8.0% below its all-time high from three-and-a-half years ago.

According to Ed Clissold, chief U.S. strategist at Ned Davis Research, the Russell’s inability to surpass its November 2021 high represents “the longest streak on record while the S&P 500 was hitting records.”

The reason some believe this is worrisome is the belief that a healthy market is one firing on all cylinders. Divergences between the small- and large-caps are therefore seen as early warning signs of trouble.

Perhaps the most successful illustration of this came in the months leading to the top of the bull market in 2007. The Russell 2000 hit its bull-market high on July 13 of that year, and was more than 12% lower three months later when the S&P 500 hit its all-time high on Oct. 9. The Global Financial Crisis ensued over the next 16 months, and in retrospect many wish they had paid attention to that divergence.

Only short-term divergences are worrisome

The reason that the nearly-four-year divergence between the S&P 500 and Russell 2000 isn’t even more worrisome than 2007’s is that long-term divergences have little market-timing significance. That’s according to Hayes Martin, president of MarketExtremes.com, who has closely studied the conditions that accompany major market turning points. “From my work” Martin wrote in an email, “I find very long-term (e.g. multi-year) divergences to have little value in identifying major tops. What matters is the degree of diverging over a period of 1-3 months.”

Consider the Russell 2000’s all-time high in November 2021. When the S&P 500 hit its bull-market high two months later, the Russell 2000 was 7% lower than its all-time high. That divergence foreshadowed the 2022 bear market, in which the S&P 500 shed more than a quarter of its value in 10 months’ time.

The situation today is more favorable. That’s because the Russell 2000 over the past three months has been every bit as strong as the S&P 500 – gaining 18.7% versus 18.2% for the S&P 500. And, as my colleague Isabel Wang reported earlier this week, the Russell 2000 is approaching its first “golden cross” in 18 months.

For this and other reasons, Martin says “there is no evidence at this time of a major top.”

Mark Hulbert is a regular contributor to MarketWatch. His Hulbert Ratings tracks investment newsletters that pay a flat fee to be audited. He can be reached at mark@hulbertratings.com

More: Benchmark small-cap index is approaching its first ‘golden cross’ in 18 months. Here’s what history shows will come next.

Plus: He’s seen enough bull markets to be worried now. But this veteran investor still likes these tech stocks.

-Mark Hulbert

This content was created by MarketWatch, which is operated by Dow Jones & Co. MarketWatch is published independently from Dow Jones Newswires and The Wall Street Journal.

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At the Society for Pediatric Dermatology (SPD) 50th Annual Meeting, 2 poster presentations shed light on often-overlooked aspects of vitiligo in children, including the mental health burden and the emerging role of diet and supplements. The first study highlights the need for integrated psychosocial care,¹ and the second explores growing but still inconclusive evidence supporting nutritional strategies as adjuncts to conventional vitiligo therapies.²

The first poster is a narrative review aimed at analyzing existing literature on the psychological effects of vitiligo in pediatric populations, focusing on depression, anxiety, body image, and self-esteem.¹ The researchers analyzed studies from 2005 to 2024 using the databases PubMed, Google Scholar, and Scopus, selecting those that evaluated mental health in children aged 5 to 18 years with vitiligo.

This review found consistently high rates of depression, anxiety, and low self-esteem among affected children—particularly those with early-onset disease, facial involvement, or limited family support. Additionally, peer bullying, academic avoidance, and cultural stigma were common themes. Furthermore, adolescents were especially vulnerable due to heightened social sensitivity. Despite this, mental health screening remains rare in pediatric dermatology settings. Therefore, the authors of the study advocate for routine psychosocial assessments and collaborative care models to address these unmet needs.

The second poster presented a systematic review examining dietary and nutritional interventions in managing vitiligo, with a particular focus on pediatric patients.² The researchers conducted a comprehensive literature search across PubMed and Embase from 2000 to 2025 using relevant keywords and screening.

Of 840 studies identified, 70 remained for full-text analysis. Preliminary findings indicated that nutrients such as vitamin D, B12, folic acid, zinc, and antioxidants like Polypodium leucotomos are the most commonly studied. Outcomes reported in the literature included varying degrees of repigmentation, lesion stability, and improvements in quality of life. However, the authors noted that most studies were limited by small sample sizes, adult-only cohorts, or inconsistent methodologies; they emphasized the need for pediatric-specific clinical trials to guide nutritional recommendations in vitiligo care.

Together, these studies emphasize the importance of a more holistic approach to pediatric vitiligo management that addresses both the emotional toll of visible skin differences and the potential role of nutritional support. Although mental health screening and support services are critically underutilized, early intervention could significantly improve quality of life. Similarly, despite promising evidence for diet-based therapies, more rigorous research tailored to pediatric populations is essential before recommendations can be standardized.

References

1. Patel B, Zaide M, Omari S. The hidden burden: Mental health impacts of vitiligo in children and adolescents. Poster presented at: Society for Pediatric Dermatology Annual Meeting; July 23-26, 2025; Seattle, WA. Abstract POS-115.

2. Cornelius K, Kumar M. Diet and nutritional supplements in the management of pediatric vitiligo. Poster presented at: Society for Pediatric Dermatology Annual Meeting; July 23-26, 2025; Seattle, WA. Abstract POS-051.

Hackers have stolen personal information of a majority of insurance firm Allianz Life’s 1.4 million customers in North America, its parent company said.

“On July 16, 2025, a malicious threat actor gained access to a third-party, cloud-based CRM system used by Allianz Life Insurance Company of North America (Allianz Life),” Allianz said in a statement to the BBC.

The German parent company added that the hackers were “able to obtain personally identifiable data related to the majority of Allianz Life’s customers, financial professionals, and select Allianz Life employees, using a social engineering technique”.

The data breach was only related to Allianz Life, according to the company.

The insurance giant disclosed the data breach in a legal filing with the attorney general in the US state of Maine.

It did not specify how many people had been affected.

In the statement, the insurance company said it had taken “immediate action” to contain the breach and had notified the FBI.

It said that there was “no evidence the Allianz Life network or other company systems were accessed, including our policy administration system”.

Allianz – which has over 125 million customers globally – added that it was in the process of contacting and assisting the individuals affected by the data breach.

A social engineering cyber-attack is when hackers pressure or trick users into giving away sensitive information, such as by impersonating a trusted company or person.

A joint road policing operation involving three forces from across the South West has seized more than 10 uninsured vehicles through number plate recognition.

Officers from Devon and Cornwall, Avon and Somerset, and Hampshire Police forces took part in the operation on Friday, to coincide with the busiest day of travel into region.

Thirteen uninsured vehicles were seized and people were also stopped for other crimes including speeding, mobile phone offences and fuel theft.

Sgt James Gallienne, from Devon and Cornwall Police, said the operation was important as “at least one person every day” is seriously injured by an uninsured or hit and run driver.”

He added: “Operations like this aim to educate about and enforce the law in order to reduce the number of uninsured drivers on the road and reduce collisions.

“Devon and Cornwall remain safe places to live and visit and we will continue to be proactive in keeping our road network safe.”

The three police forces worked alongside the Motor Insurers’ Bureau (MIB) using Automatic Number Plate Recognition to monitor interchanges on the A30, A38 and A380 to identify uninsured vehicles.

“Every 20 minutes, someone is falling victim to an uninsured or hit-and-run driver, with one person so seriously injured that they require life-long care,” the MIB said.

“Removing uninsured vehicles from the road helps protect all road users from potential harm.

“Additionally, uninsured drivers are frequently linked to other criminal activities, including drug or drink driving, excessive speeding, and organised crime such as drug running.”

Roads policing inspector Matt Boiles, from Avon and Somerset Police, added: “We typically see a significant rise in traffic volumes at the start of the summer holidays as people travel to and through our region.

“By targeting uninsured vehicles, we’re aiming to reduce risk to all road users during one of the busiest times of year.”

The MIB said many of the drivers of the seized vehicles were knowingly uninsured but urged all drivers to check their insurance status

• Palantir has witnessed a meteoric rise in its share price thanks to the company’s successful foray into the artificial intelligence (AI) arena.

• Several respected investors on Wall Street have been applying different approaches when it comes to investing in Palantir, making it hard to discern how “smart money” feels about the company.

• Palantir is trading for a historically high valuation, and broader buying and selling themes from institutional money managers could suggest a sell-off is on the horizon.

• 10 stocks we like better than Palantir Technologies ›

Outside of Nvidia, I’d argue that no other company has benefited from the tailwinds of the artificial intelligence (AI) revolution as much as data mining specialist Palantir Technologies (NASDAQ: PLTR).

Over the last three years, shares of Palantir have gained more than 1,300%. Just this year alone, Palantir stock has rocketed by 97%. To put that into perspective, the S&P 500 and Nasdaq Composite indexes haven’t even posted gains of 10% in 2025.

While it can be tempting to follow the momentum in hopes of more outsize gains, smart investors understand that hope is not a real strategy.

Let’s explore the catalysts behind Palantir’s generational run, and assess some recent trading activity to help discern whether Palantir stock could be headed even higher.

When AI first started to emerge as the next megatrend during late 2022 and early 2023, investors were consistently bombarded with news around big tech’s splashy investments in the space. Microsoft plowed $10 billion into OpenAI, the maker of ChatGPT. Both Amazon and Alphabet invested hefty sums into a competing platform, called Anthropic. Tesla was touting its advancements in self-driving cars and humanoid robots. You get the drift — the AI narrative largely hinged on the moves big tech was making.

But in the background, Palantir was building. In April 2023, the company launched its fourth major software suite — the Palantir Artificial Intelligence Platform (AIP).

As the graph above illustrates, Palantir was a relatively slow-growth, cash-burning enterprise prior to the release of AIP. But since AIP’s launch a little more than two years ago, Palantir’s revenue has accelerated considerably. On top of that, the company has been able to command improving unit economics underscored by a sweeping transition to positive net income and generating billions in free cash flow.

At the end of 2022, Palantir had 367 total customers. As of the end of the first quarter this year, Palantir boasted 769 total customers. Perhaps even more impressive is that the company’s commercial customers (non-government) have risen by more than twofold over the last couple of years.

To me, AIP is serving as a gateway for Palantir to expand its reach beyond federal contracts with the U.S. military, which is what Palantir is best known for. AIP represents a transformational shift as a defense contractor to a more ubiquitous software platform capable of penetrating the private sector, despite relentless competition from larger companies such as Salesforce or SAP.

As a Palantir bull myself, I’ve been blown away by management’s ability to outmaneuver big tech and deliver on lofty growth targets time and again. But as an investor, I can’t help but wonder if the company’s share price trajectory is sustainable.

In addition to analyzing financial trends and operating metrics, investors can augment their due diligence process by listening to how Wall Street analysts talk about a company or even dig into the trading activity of notable investors. Thanks to a nifty tool called a form 13F, investors can access an itemized breakdown of all of the buys and sells from hedge funds during a given quarter.

During the first quarter, famed billionaire investor Stanley Druckenmiller sold out of his fund’s Palantir position. In addition, Cathie Wood has been trimming exposure to Palantir in Ark’s portfolio as well.

On the flip side, billionaire investors Ken Griffin and Israel Englander both added to their funds’ respective Palantir positions during the first quarter. Given these dynamics, it might be hard to discern how Wall Street really feels about Palantir.

I think there are some nuances to point out given the details above. First, both Druckenmiller and Wood have been in and out of Palantir stock in the past — this is not the first time each investor reduced their exposure to the data analytics darling.

On top of that, I think Griffin’s and Englander’s activity should be taken with a grain of salt. Both investors run highly sophisticated, multistrategy hedge funds. From time to time, some of this activity may include being a market maker.

Although it may appear bullish that Palantir stock is held in Griffin’s Citadel and Englander’s Millennium Management portfolios, I wouldn’t quite buy that narrative. Neither fund is necessarily known for holding positions for the long term.

Moreover, as a multistrategy fund with a number of different teams and objectives, I think that it’s highly likely that Citadel and Millennium have a layered and complex hedge strategy when it comes to owning a volatile growth stock such as Palantir.

The chart below illustrates institutional buying and selling of Palantir stock over the last few years.

Given that buying (the purple line) remains elevated over selling (the orange line), this could suggest that Palantir remains a favorite among institutional portfolios. However, as I expressed above, not all hedge funds and money managers have the same strategy. In other words, some of this elevated buying could be part of a broader, more complex trading strategy and less so an endorsement of long-term accumulation.

Over the last few months, Palantir stock has become increasingly more expensive. In fact, the company is trading well beyond levels seen during peak days of the dot-com or COVID-19 bubbles.

While it’s impossible to know for certain where Palantir stock will be trading by the end of the year, smart investors know that nothing goes up in a straight line forever.

A good indicator for how investors feel about Palantir’s prospects should come after the company reports second-quarter earnings in a couple of weeks. As a reminder, shares fell off a cliff for a brief moment following the company’s first-quarter blowout report. Expectations are rising with each passing report, and I would not be surprised to see Palantir stock sell off again — even if its Q2 results are stellar.

Given the convergence between institutional buying and selling, combined with Palantir’s increasingly expensive valuation, I can’t help but be cautious at this point. I do think a valuation correction could be in store sooner or later and would not be surprised if shares are trading for a considerably lower price by the end of the year.

Before you buy stock in Palantir Technologies, consider this:

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Adam Spatacco has positions in Alphabet, Amazon, Microsoft, Nvidia, Palantir Technologies, and Tesla. The Motley Fool has positions in and recommends Alphabet, Amazon, Microsoft, Nvidia, Palantir Technologies, Salesforce, and Tesla. The Motley Fool recommends the following options: long January 2026 $395 calls on Microsoft and short January 2026 $405 calls on Microsoft. The Motley Fool has a disclosure policy.

After Soaring Nearly 100% So Far This Year, Where Will Palantir Stock Be at the End of 2025? was originally published by The Motley Fool

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