Category: 3. Business

  • ‘Disorder, fright and confusion’: looking back at the devastating Wall Street crash of 1929 | Books

    ‘Disorder, fright and confusion’: looking back at the devastating Wall Street crash of 1929 | Books

    Andrew Ross Sorkin’s first book, Too Big to Fail, was a bestseller about the financial crisis of 2008, published the following year. His second, 1929, out this week, takes readers “Inside the Greatest Crash in Wall Street History – and How it Shattered a Nation”.

    It’s been 16 years between books, but Sorkin hasn’t been idle. A columnist for the New York Times, he founded its DealBook newsletter and summit; he’s a Squawk Box co-anchor for CNBC; and after Too Big to Fail was filmed by HBO, he co-created Billions, a huge hit for Showtime starring Damian Lewis and Paul Giamatti.

    After Too Big to Fail, Sorkin said, he was “often asked about 1929. I actually didn’t know much. I had read JK Galbraith [The Great Crash, 1929, published in 1955] and a couple other books. And most people I knew, we would all sort of talk about 1929 as this terrible calamity, but nobody … knew what actually happened – who the people were, what they said to each other, what the motivations were, what the incentives were, what the lessons actually were.”

    The short version of what happened in 1929 is that a stock market built on fast credit and wild speculation suffered a series of falls culminating in the Black Thursday crash on 24 October, in Galbraith’s words a day “measured by disorder, fright, and confusion”.

    Combined with factors including protectionist tariffs and rising unemployment, the crash was a key signpost to a devastating global depression.

    “About a decade ago,” seeking a way into the story, Sorkin went on vacation and “like a real nerd, downloaded some books to a Kindle … and I remember reading them, thinking: ‘Wow, this is so much more interesting than I knew,’ but also feeling most of the books about this period were written in the 1930s, some in the 40s, 50s. I think there’s one that was maybe the 70s. And a lot of them were written by economists … told through charts and data and economic systems. And I wanted the human drama.

    The cover of 1929. Photograph: Viking/Penguin

    “One of the lessons of writing Too Big to Fail was, we talk about business and the economy oftentimes in big numbers and structures and systems, but it really is ultimately about people and the decisions they make. So I thought: ‘Maybe there’s an opening to write a book like that.”

    A visit to Harvard allowed a look at the papers of Thomas Lamont, a partner at JP Morgan, including transcripts of White House talks with President Herbert Hoover. Allowing for myriad commitments and the challenges of pandemic-era research, Sorkin’s book was a go.

    As influences for a book based on first-hand sources found in countless archives, Sorkin cites business classics: Den of Thieves by James B Stewart, about insider trading; Liar’s Poker by Michael Lewis, about bonds traders; and Barbarians at the Gate by Bryan Burrough and John Helyar, about the fall of RJR Nabisco.

    “Widening the aperture”, a phrase Sorkin uses to describe a project that encompasses earlier panics (1907, 1921) and the long aftermath of 1929, he also looked to Walter Lord’s A Night to Remember, from 1955, as “really the definitive in-the-room account of the sinking of the Titanic” and “actually a little bit like a mental model … [for] a way I wanted the reader to be able to feel.”

    The crash of 1929 was indeed like a shipwreck. Livelihoods were lost when the market capsized, though Sorkin confirms that one image in the popular imagination, of ruined brokers leaping from Wall Street windows, is not what actually happened. For a while, it seemed the economy might recover. It took other factors, prominently including the Smoot-Hawley Tariff Act of 1930, to bring about depression.

    As Sorkin’s book comes out, Donald Trump’s tariffs and their effects are in the news. Sorkin said he wrote with an eye on current events but preferred not to oversell such parallels, instead seeking chiefly to present relatable characters.

    “I’m always trying to understand where the drive comes from, where the motivation comes from, for whatever the decision is that people are making,” Sorkin said, citing experience gained “in the context of Billions and the making of the movie Too Big to Fail” as well as “what I try to do with my journalism every day.

    “Oftentimes it was to try to understand: ‘Well, what is it that’s driving Charlie Mitchell?’ … or: ‘What was it about Carter Glass in his childhood that led him to be this sort of very unique character?’ Similarly with Lamont and John Raskob and so many others.”

    The front page of the Brooklyn Daily Eagle newspaper. Photograph: Icon Communications/Getty Images

    Mitchell, CEO of National City Bank, a casualty of the crash, was hauled before Congress and into court on tax charges. Glass was a senator from Virginia who drove reform to protect ordinary Americans from Wall Street excess. Raskob, an executive at DuPont and General Motors, chaired the Democratic National Committee.

    One way Sorkin seeks to make such characters relatable is to depict their use of technology to master fast-moving markets – analog telephones in serried ranks on desks above Wall Street now home to computers. He’s also happy to compare key players to equivalents today.

    Considering Glass, a Virginia conservative, Sorkin looks to a current senator from Massachusetts, decidedly more progressive, the force behind the Consumer Financial Protection Bureau, formed after 2008 to protect ordinary investors.

    “If Elizabeth Warren was a racist, that’s who [Glass] would be,” Sorkin laughed. “But what, to me, was so interesting about [Glass] was also that … he was cited after the 2008 financial crisis as one of the great bastions of the regulatory world. I think liberals really loved him. They thought that he was really trying to hold Wall Street to account.

    “And I went into this project thinking about that narrative, and … as the story progresses, it is so much more complicated than that. I’m not sure Elizabeth Warren would be citing Carter Glass today if she really understood the full dynamic of how the Glass-Steagall Bill was created.

    “I thought of Glass-Steagall [also named for Henry B Steagall, a congressman from Alabama] as this famous bill that broke up the banks and was really meant to end the casino [gambling on the markets], and then you realize … the real movers weren’t even politicians, to some degree they were bankers who were trying to screw each other. And maybe it just represents how this world is actually no different than it is today, in many ways, in terms of how the sausage gets made.”

    Among those bankers, Sorkin found Mitchell “sort of a villain, but not really” and compelling because “I love characters that are not black and white. And he was so interesting to me because he was as famous as Jamie Dimon [CEO of JPMorgan Chase] would be today. But there were aspects of [Mitchell] that might have been more like a Michael Milken,” the insider trader jailed in 1990 then pardoned by Trump in 2020.

    “Charlie Mitchell created credit and leverage in the system to loan money to ordinary investors, which in large part is what led to the crash. Michael Milken revolutionized the debt markets and the credit markets in the 80s by loaning high-yield bonds, or what people call junk bonds, to less good credits. And they both were arrested. The outcome was slightly different, but they were both hated.”

    Knowing today’s titans well – it was his question that memorably prompted Elon Musk to tell critics “go fuck yourself” – Sorkin is well placed to make comparisons. Regarding another key character in 1929, the Tesla, SpaceX and X owner duly enters the chat.

    Andrew Ross Sorkin. Photograph: Mike Cohen

    “To me, John Raskob is like Elon Musk. Think about a businessman who was involved in everything. Cars, obviously, General Motors, and [Raskob] gets involved in politics … starting to try to damage the reputation of Hoover by doing all of these back-channel projects. And then he’s building the equivalent of a spaceship, the Empire State Building. And he also happens to have 13 children.”

    Among the supporting cast, there’s Hoover, the technocratic president who rebranded the post-crash “panic” as a “depression”, inadvertently sealing his reputation as a failure, left to watch Franklin D Roosevelt save the day. Sorkin also depicts Winston Churchill, a decade away from his finest hour as British prime minister, in debt to his shirtmaker, playing the Manhattan markets anyway, wandering Fifth Avenue, there to be hit by a car.

    Financial calamity brings political fallout. In the second half of 1929, Sorkin’s story moves to Washington and attempts to hold Wall Street accountable. As in 2008, most main players avoided serious penalties.

    Clearly, Sorkin is going to get more questions about what 1929 might teach us about 2025 and a US economy showing signs of trauma, Trump-induced or not.

    He said: “There are a lot of parallels that I imagine people could draw out. I mean, look at the idea today and the idea back then of democratizing finance.”

    In 1929, “democratizing finance” meant opening the markets to ordinary Americans through unchecked credit.

    “Today,” Sorkin said, “what do they talk about democratizing finance? They just passed a bill that Trump signed that’s going to allow private equity and venture capital and private credit into your 401(k) plan. That’s all about democratizing finance. Crypto is now a thing that’s about democratizing finance. Obviously, the tariffs are almost a super-direct parallel.”

    Another Trump obsession, bending the central bank to his will, is also foreshadowed in Sorkin’s book.

    “There’s the whole debate the Fed is having in the spring of 1929 about whether to raise or lower interest rates,” Sorkin said. “To some degree, [there are] even debates about the independence of the Fed … So I think there’s lots of things that do seem familiar.”

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  • Trump’s tariffs are brewing trouble for local coffee roasters

    Trump’s tariffs are brewing trouble for local coffee roasters

    The rising costs of coffee beans are keeping roasters and their customers on edge.

    Retail coffee prices jumped nearly 21% in August compared to the same time last year, and the Trump administration’s tariffs are partially to blame: In July, Brazil was slapped with one of the highest duties, at 50%, while Vietnam has 20% tariffs and Colombia has 10% tariffs.

    America imports more than 99% of its coffee, according to the National Coffee Association. Most of it comes from Brazil — 30.7% of US coffee imports based on net weight, according to the UN Comtrade Database — Colombia (18.3%) and Vietnam (6.6%).

    The average price of regular coffee at restaurants in August was 10 cents more than the same time last year, according to data from Toast, a restaurant management software provider. The increase brought the average price to $3.52.

    Some relief may be on the way. In September, Rep. Don Bacon, a Republican from Nebraska, and Democratic Rep. Ro Khanna of California, introduced the bipartisan “No Coffee Tax Act” to exempt coffee products from tariffs.

    Price hikes may cause some consumers to start brewing their coffee at home, but they will likely continue buying cups from local shops as occasional indulgences.

    “(Consumers) may change brands, or they may shop for deals, or perhaps go down in quality — or what they perceive as a quality level — in order to save a little bit of money,” said Erin McLaughlin, a senior economist at the Conference Board, a nonprofit research group.

    Coffee drinkers in the nation’s capital are seeing more expensive drip and espressos these days. According to data from Toast, a regular hot coffee in Washington, DC, averaged $4.21 in August, up 4% from last year. And the average price of a cold brew costs $5.35, up 3.7% year-over-year.

    Swing’s Coffee Roasters, which was founded in 1916 and has three locations in Virginia and Washington, DC, has been hit with higher-than-usual costs. Owner Mark Warmuth told CNN that Trump’s tariffs caused a “really difficult situation across the board” when combined with environmental and labor factors that make coffee more expensive.

    “Consumers are footing the bill for it,” Warmuth said, adding that “the only loser here is the consumer.”

    The cost of a single cup could go up about 10 or 15 cents, Warmuth warned. Even if importing beans costs 50% more, it’s unlikely a single cup would also increase 50%.

    DC coffee drinkers may wince at the price, but they aren’t likely to give up their caffeine fix.

    Swing's Coffee Roasters in Washington, DC, faces uncertainty about the implementation of Trump's tariffs.

    “(Coffee is) kind of considered an affordable luxury. While it might go from $3 a cup to $3.50 a cup, that may not be enough in downtown DC to cause somebody to change their consumption habits,” he added.

    Chris Vigilante, owner of Vigilante Coffee Company, which has two locations in California and Maryland, said an average pound of coffee has gone up from about $4 to as much as $6. And a 12-ounce bag of beans could increase by 50 cents to $1 for customers, he said.

    Vigilante imports much of its coffee from Brazil, and other beans come from countries including Indonesia, Ethiopia and Colombia. Amid federal layoffs and other pressures affecting DC residents, he said Vigilante Coffee Company has considered importing coffee from other countries to “diversify our offerings and keep certain price points for our customer base.”

    Despite price increases, Vigilante said he’s optimistic that there are still ways “folks can continue to enjoy great specialty coffee (that) works for their wallet.”

    Chris Vigilante in front of one of his coffee shops in College Park, Maryland, in September 2021.
    A man passes by Qualia Coffee on April 2, 2023, in Washington, DC.

    The 50% tariff on top US exporter Brazil, which has seen its coffee bean supply shrink due to a drought, weighs the heaviest on businesses.

    Doug Ilg, the owner of Celtic Cup Coffee Roasting in Silver Spring, Maryland, has avoided Brazilian coffee because of the huge tariffs. He doesn’t import coffee himself but buys primarily from third parties and has noticed costs rise in the last eight months.

    Trump’s tariffs “definitely changed things,” Ilg said.

    For instance, customers now may pay roughly 63 cents more per pound of beans compared to January because of the additional cost of tariffs this year, he said.

    The additional costs also put more pressure on small and medium-sized businesses that invest more upfront, said McLaughlin of the Conference Board.

    Joel Finkelstein, the owner of Qualia Coffee, which sells at farmers’ markets around DC, said it’s “really hard” to anticipate where his business will be in a year or two because of factors such as uncertainty about pricing.

    “Every small business, unless you’re in a very fortunate position, is constantly assessing whether it makes sense to stay open,” Finkelstein said.

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  • A Service Evaluation of Antenatal Detection of Small-for-Gestational-Age Infants in a UK National Health Service Trust

    A Service Evaluation of Antenatal Detection of Small-for-Gestational-Age Infants in a UK National Health Service Trust


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  • Trodelvy® Reduces Risk of Disease Progression or Death by 38% Versus Chemotherapy as First-Line Therapy in Patients With Metastatic Triple-Negative Breast Cancer in ASCENT-03 Study

    – Late-Breaking ASCENT-03 Data Simultaneously Presented at ESMO 2025 and Published in The New England Journal of Medicine –

    – With Two Positive Phase 3 Trials, Trodelvy Has Potential as the First and Only ADC to be a Backbone Standard of Care for All First-Line Metastatic TNBC Patients Regardless of PD-L1 Status –


    Gilead Sciences, Inc. (Nasdaq: GILD) today shared positive data from the Phase 3 ASCENT-03 study demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) for Trodelvy® (sacituzumab govitecan-hziy) compared to chemotherapy as first-line treatment in patients with metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitors. These findings will be presented today during a late-breaking oral session at the 2025 European Society for Medical Oncology (ESMO) Congress (Abstract #LBA20) and simultaneously published in The New England Journal of Medicine.

    ASCENT-03 successfully met its primary endpoint of PFS with a 38% reduced risk of disease progression or death for Trodelvy versus chemotherapy (HR: 0.62; p<0.0001). Median PFS with Trodelvy was 9.7 months versus 6.9 months for chemotherapy. The PFS results for Trodelvy versus chemotherapy were consistent across prespecified subgroups, including among patients with poorer prognosis (such as those whose cancer recurred less than one year after treatment in the curative setting) and regardless of chemotherapy chosen.

    “Patients with metastatic TNBC who are ineligible for immunotherapy face an especially poor prognosis, with limited treatment options and fast disease progression,” said Dr. Javier Cortés, Head of the International Breast Cancer Center in Spain and principal investigator of the ASCENT-03 study. “The ability of sacituzumab govitecan to significantly delay death and progression could represent the first major treatment advance for this patient population in the 20 years since TNBC was defined, marking an historic shift and establishing a potential new standard of care.”

    The objective response rate (ORR) was 48% with Trodelvy and 46% with chemotherapy. Median duration of response (DOR) was substantially longer with Trodelvy. Among patients with confirmed complete or partial responses, DOR for Trodelvy was 12.2 months compared to 7.2 months with chemotherapy.

    Overall survival (OS) data were not mature at the time of PFS primary analysis. Gilead will continue to monitor OS outcomes, with ongoing patient follow-up and further analysis planned.

    These results complement the recent presentation of ASCENT-04/KEYNOTE-D19, which showed a significant PFS benefit for Trodelvy plus Keytruda® (pembrolizumab) in PD-L1+ first-line metastatic TNBC. Gilead is engaging with the U.S. Food and Drug Administration and other global regulators regarding both data sets.

    “ASCENT-03 is the second Phase 3 trial with a Trodelvy-based regimen to show superior progression-free survival over chemotherapy in first-line metastatic TNBC, highlighting its potential to improve outcomes for patients with limited treatment options,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “With these potentially practice-changing results, Trodelvy is poised to transform the first-line metastatic TNBC treatment landscape, offering a much-needed alternative to chemotherapy.”

    Summary of Key ASCENT-03 Results

    Efficacy: Intent-to-Treat Population

    Trodelvy (n=279)

    Chemotherapy (n=279)

    Median PFS

    9.7 months (95% CI: 8.1-11.1)

    6.9 months (95% CI: 5.6-8.2)

    PFS hazard ratio and p-value

    0.62 (95% CI: 0.50-0.77); p<0.0001

    ORR

    48% (95% CI: 42-54)

    46% (95% CI: 40-52)

    DOR

    12.2 months (95% CI: 9.7-13.8)

    7.2 months (95% CI: 5.7-8.4)

    The safety profile of Trodelvy in the ASCENT-03 study was consistent with prior studies, and no new safety signals were identified in this patient population. The most frequent grade ≥3 treatment-emergent adverse events were neutropenia (43%) and diarrhea (9%) with Trodelvy and neutropenia (41%) and anemia (16%) with chemotherapy. Fewer patients discontinued treatment due to adverse events on Trodelvy than with chemotherapy (4% vs. 12%).

    Healthcare professionals have well-established experience with Trodelvy, with more than 60,000 breast cancer patients treated across 50+ countries over the past five years. It remains the only Trop-2-directed antibody-drug conjugate (ADC) to demonstrate meaningful survival benefits in both 2L+ metastatic TNBC and pre-treated HR+/HER2- metastatic breast cancer. It is also the only ADC with four positive Phase 3 trials in HER2- mBC (IHC 0, IHC 1+, or IHC 2+/ISH–).

    The use of Trodelvy plus Keytruda in patients with first-line PD-L1+ metastatic TNBC and Trodelvy as monotherapy in patients with first-line metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors are investigational, and the safety and efficacy of these uses have not been established.

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

    About Triple-Negative Breast Cancer (In Patients Who Are Not Candidates for PD-1/PD-L1 inhibitors)

    Triple-negative breast cancer (TNBC) is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionately impacts younger, pre-menopausal as well as Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.

    Chemotherapy remains the mainstay of treatment in first-line metastatic TNBC patients who are not candidates for PD-1/PD-L1 inhibitors, and the need to improve outcomes continues to be high as there has not been a clinically meaningful advance for this patient population in over 20 years. In metastatic TNBC overall, ~50% of patients do not receive treatment beyond the first-line setting, demonstrating a need for additional effective earlier-line treatment options.

    About the ASCENT-03 Study

    The ASCENT-03 study is a global, open-label, randomized Phase 3 trial evaluating the efficacy and safety of Trodelvy compared with treatment of physician’s choice in patients with previously untreated, locally advanced, inoperable, or metastatic triple-negative breast cancer whose tumors do not express PD-L1, or who are PD-L1 positive and previously treated with a PD-(L)1 inhibitor in the curative setting. 558 patients were enrolled across multiple study sites worldwide.

    Patients were randomized 1:1 to receive either Trodelvy (10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle) or treatment of physician’s choice, which included gemcitabine plus carboplatin, paclitaxel, or nab-paclitaxel. Treatment continued until blinded independent central review (BICR)-verified disease progression or unacceptable toxicity. Patients randomized to chemotherapy were eligible to cross over to Trodelvy upon disease progression.

    The primary endpoint of the study is progression-free survival (PFS) as assessed by BICR according to RECIST v1.1. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), time to onset of response (TTR), patient-reported outcomes (PROs) and safety.

    More information about ASCENT-03 is available at ClinicalTrials.gov: NCT05382299.

    About Trodelvy

    Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.

    Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) patients and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.

    Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

    INDICATIONS

    TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

    • Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
    • Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

    IMPORTANT SAFETY INFORMATION

    BOXED WARNING: NEUTROPENIA AND DIARRHEA

    • TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
    • TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.

    CONTRAINDICATIONS

    • Severe hypersensitivity reaction to TRODELVY.

    WARNINGS AND PRECAUTIONS

    Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

    Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

    Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

    Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

    Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

    Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

    ADVERSE REACTIONS

    In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

    In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

    In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

    DRUG INTERACTIONS

    UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

    UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

    Please see full Prescribing Information, including BOXED WARNING.

    About Gilead and Kite Oncology

    Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer.

    About Gilead Sciences

    Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.

    Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving Trodelvy (such as ASCENT-03); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

    Trodelvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

    U.S. Prescribing Information for Trodelvy, including BOXED WARNING, is available at www.gilead.com.

    For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).


    Source: Gilead Sciences, Inc.

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  • ESMO: Tubulis’ next-gen ADC posts 59% response rate, justifying investor interest – Fierce Biotech

    1. ESMO: Tubulis’ next-gen ADC posts 59% response rate, justifying investor interest  Fierce Biotech
    2. German biotech firm Tubulis raises $358 million to develop targeted cancer treatments  MSN
    3. Tubulis lands record 308 million euro funding to advance ADC pipeline  The Pharma Letter
    4. Wellington Management Joins $361M Series C for Cancer Drug Developer Tubulis  citybiz
    5. Research transfer: LMU spin-off Tubulis secures financing for cancer research  LMU München

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  • FLAURA2 Trial: Osimertinib Plus Chemotherapy Improves Overall Survival Across Prognostic Subgroups in EGFR-Mutated Advanced NSCLC — Presented at ESMO 2025

    FLAURA2 Trial: Osimertinib Plus Chemotherapy Improves Overall Survival Across Prognostic Subgroups in EGFR-Mutated Advanced NSCLC — Presented at ESMO 2025

    The Phase 3 FLAURA2 trial (NCT04035486) continues to strengthen the role of combination therapy in the first-line management of EGFR-mutated (EGFRm) advanced non–small cell lung cancer (NSCLC). At ESMO 2025, investigators reported the final overall survival (OS) analysis, showing that osimertinib (osi) plus platinum–pemetrexed chemotherapy (CTx) achieved a statistically significant and clinically meaningful OS improvement compared with osimertinib monotherapy.

    This milestone confirms the combination as a first-line standard of care in EGFRm NSCLC, offering durable efficacy across key subgroups, including those with traditionally poor prognostic features such as CNS metastases, L858R mutations, plasma-detectable EGFRm, and altered TP53.

    Methods

    The FLAURA2 trial enrolled 557 patients with EGFRm advanced NSCLC, who were randomized 1:1 to receive osimertinib plus chemotherapy (n=279) or osimertinib alone (n=278). The chemotherapy regimen consisted of platinum–pemetrexed, administered concurrently with osimertinib.

    Baseline CNS imaging (CT or MRI) was mandatory to identify central nervous system metastases. EGFR mutation subtypes (Ex19del or L858R) were confirmed through central or locally approved assays. Plasma EGFR mutation detection was evaluated via droplet digital PCR (Biodesix), while TP53 mutation status was determined using FoundationOne CDx.

    OS outcomes were analyzed using an unstratified Cox proportional hazards model, with subgroup analyses conducted based on baseline prognostic factors.

    Results

    A total of 557 patients were included: 279 in the osimertinib + CTx arm and 278 in the osimertinib monotherapy arm. The overall hazard ratio (HR) for OS was 0.77 (95% CI 0.61–0.96; p=0.02), corresponding to a 23% reduction in risk of death with the combination regimen.

    CNS Metastases

    In patients with baseline CNS metastases, median OS reached 40.9 months (95% CI 35.2–46.6) with osimertinib + CTx versus 29.7 months (95% CI 25.6–35.8) with monotherapy (HR 0.72; 95% CI 0.52–0.99).

    EGFR Mutation Subtype

    Both EGFRm subgroups derived benefit.

    • L858R: median OS 38.1 vs 32.4 months (HR 0.76; 95% CI 0.55–1.07)
    • Ex19del: median OS not reached (NR) vs 43.0 months (HR 0.76; 95% CI 0.56–1.02)

    Plasma EGFR Mutation Detection

    Patients with detectable plasma EGFRm achieved median OS 38.4 vs 32.5 months (HR 0.79; 95% CI 0.60–1.03), while those with undetectable mutations had not reached median OS in either arm.

    TP53 Alteration Status

    Among patients with altered TP53, OS improved to 51.1 months vs 43.1 months (HR 0.71; 95% CI 0.40–1.27), showing consistent benefit across molecular profiles.

    No new safety signals were reported, confirming that the addition of chemotherapy did not compromise the established tolerability of osimertinib.

    flaura2-trial

    Interpretation

    The survival improvement observed with osimertinib plus chemotherapy extended across every prognostic subgroup examined. The HRs for OS within each category closely mirrored those of the overall intent-to-treat (ITT) population, highlighting the robustness and reproducibility of the benefit.

    Particularly noteworthy were the gains among patients with CNS metastases and L858R mutation, two subsets traditionally associated with poorer prognosis. These data underline the capacity of the combination regimen to overcome key resistance mechanisms and delay disease progression.

    flaura2-trial

    Long-Term Follow-Up and Analytical Considerations

    The long-term follow-up from the FLAURA2 trial at ESMO 2025 provides the most comprehensive survival dataset to date for EGFR-mutated NSCLC treated with first-line osimertinib plus chemotherapy. With several subgroups not yet reaching median OS, the sustained separation of survival curves indicates a persistent and cumulative treatment effect extending well beyond the chemotherapy phase.

    Investigators emphasized that the survival curves for osimertinib + CTx began to diverge early—within the first year of treatment—and remained separated throughout follow-up, suggesting that early dual blockade of EGFR signaling and microenvironmental suppression via chemotherapy offers durable control of micrometastatic disease.

    The analysis also highlights that median OS was not reached in multiple subgroups, demonstrating an ongoing trend toward improved long-term outcomes. The consistency of benefit across genomic and clinical subgroups—including those with TP53 alterations or detectable circulating tumor DNA—supports the biological rationale that concurrent chemotherapy may help prevent the emergence of resistant clones.

    Methodologically, the trial’s unstratified Cox model ensured unbiased subgroup comparisons and confirmed that the treatment effect was independent of baseline risk characteristics. Furthermore, despite crossover and subsequent therapies available post-progression, the OS advantage with osimertinib plus chemotherapy persisted, reinforcing the value of front-line combination therapy over sequential monotherapy strategies.

    No late-emerging toxicities or cumulative safety concerns were identified during long-term follow-up, strengthening the safety profile of the regimen. Together, these findings establish osimertinib plus chemotherapy as a durable, well-tolerated, and biologically rational first-line standard of care for patients with EGFR-mutated advanced NSCLC.

     

    Read Full Abstract on ESMO Congress 2025 Website 

    You Can Watch More on OncoDaily Youtube TV

    Written by Armen Gevorgyan, MD

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  • EV + Pembrolizumab Boosts Survival in MIBC

    EV + Pembrolizumab Boosts Survival in MIBC

    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%

    KEYNOTE-905/EV-303 trial

    • 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%

    KEYNOTE-905/EV-303 trial

    • 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).

    KEYNOTE-905/EV-303 trial

     

    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.

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  • “On the Fence About Buying Drone Companies that Aren’t Making Money”

    “On the Fence About Buying Drone Companies that Aren’t Making Money”

    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.

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  • Assessing Futu Holdings (NasdaqGM:FUTU) Valuation After a 100% Year-to-Date Share Price Surge

    Assessing Futu Holdings (NasdaqGM:FUTU) Valuation After a 100% Year-to-Date Share Price Surge

    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.

    NasdaqGM:FUTU PE Ratio as at Oct 2025

    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

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  • A US-China trade dispute over a little-known Dutch chipmaker could bring auto plants to a halt and send car prices higher

    A US-China trade dispute over a little-known Dutch chipmaker could bring auto plants to a halt and send car prices higher

    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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