Category: 3. Business

EU trade chief Maros Sefcovic said on social media that, effective immediately, exports of the company’s chips to the bloc for non-military uses will not be subject to Chinese licensing requirements.

“My team and I have been in constant contact with the Chinese authorities, and welcome the confirmation provided today to the European Commission by Mofcom regarding the further simplification of export procedures for next-period chips destined for EU and global clients,” Sefcovic said.

“Mofcom will grant exemptions from licensing requirements to any exporter, provided that it is declared that the goods are intended for civilian use,” he added.

“Close engagement with both the Chinese and Dutch authorities continues as we work towards a lasting, stable, predictable framework that ensures the full restoration of semiconductor flows.”

Compared with placebo, PCSK9 inhibition with evolocumab reduced the risk of first cardiovascular events among patients with atherosclerosis or diabetes and without a previous myocardial infarction or stroke, based on findings from the VESALIUS-CV trial presented at AHA 2025 and simultaneously published in NEJM.

Researchers randomly assigned 12,257 patients to receive either evolocumab (140mg every two weeks; n=6,129) or placebo (n=6,128). All participants had an LDL-C level of at least 90 mg per deciliter, 43% were women, 93% were white and the median age was 66 years. The two primary end points were a composite of death from coronary heart disease, myocardial infarction or ischemic stroke (3-point MACE) and a composite of 3-point MACE or ischemia-driven arterial revascularization (4-point MACE).

Overall results showed evolocumab reduced the risk of coronary heart disease death, heart attack or ischemic stroke by 25%. Participants in the evolocumab group also experienced a 19% reduction in the risk of death, heart attack, ischemic stroke or arterial revascularization over a median follow-up period of 4.5 years.

According to researchers, the dual primary endpoints were consistent across key subgroups, including in participants with high-risk diabetes without qualifying ASCVD, who represented roughly one-third of the total study population. In a substudy evaluating LDL-C levels over time, LDL-C was lowered by nearly 55% in the evolocumab group at 48 weeks, resulting in a median LDL-C level of 45 mg/dL compared with 115 mg/dL at enrollment. In contrast, LDL-C levels remained elevated among those in the placebo group, at a median of 109 mg/dL.

“The results from the VESALIUS-CV trial represent the first demonstration of improved cardiovascular outcomes with a PCSK9 inhibitor, or any nonstatin for that matter, in patients without a previous heart attack or stroke who are already being treated with a high-intensity lipid-lowering regimen ,” said Erin Ann Bohula, MD, DPhil, FACC, who presented the findings.

The study had several limitations to note, including that a small group of patients (8%) were not being treated with any cholesterol-lowering treatment at the beginning of the study. In addition, the majority of study participants were White. Further studies that include participants of various racial and ethnic backgrounds are needed to confirm if these findings apply across diverse populations, said Bohula.

In a related editorial comment published in NEJM, Chiadi E. Ndumele, MD, PhD, and Roger S. Blumenthal, MD, FACC, say the findings “represent an important step forward in clinical knowledge.” They write: “Although PCSK9 inhibitors had been shown to reduce the risk of atherosclerotic cardiovascular disease events among patients with previous myocardial infarction or stroke, this new trial has shown their clinical benefit in patients without previous myocardial infarction or stroke. With a longer follow up than earlier PCSK9 inhibitor trials … numerically fewer deaths were observed in the evolocumab group than in the placebo group. Although this result was not significant owing to the hierarchical testing approach, it is likely to reflect a true signal.”

Clinical Topics:
Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention

Keywords:
AHA Annual Scientific Sessions, AHA25, Dyslipidemias, Secondary Prevention

• NetScout Systems reported second-quarter earnings that surpassed analyst expectations, with revenue reaching US$219.02 million and net income climbing to US$25.83 million, while also raising full-year guidance for both revenue and earnings per share.

• This performance marked a reversal from a net loss in the prior year and highlighted operational momentum across both service and product segments.

• We’ll look at how NetScout’s raised full-year guidance and strong earnings result shape its evolving investment narrative.

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To be a shareholder in NetScout Systems, you need to believe in its ongoing ability to grow revenue by delivering reliable service assurance and cybersecurity solutions for enterprises amid rising network and threat complexity. The recent earnings beat and raised full-year guidance reinforce near-term optimism, but do not fundamentally shift the most relevant short-term catalyst: accelerating enterprise demand for cybersecurity products. The largest risk, rapid migration to cloud-native architectures and product consolidation, remains material and unchanged by these results. Among recent announcements, NetScout’s October launch of the Omnis KlearSight Sensor for Kubernetes directly addresses evolving customer needs in cloud environments, closely linked to the company’s ambitions around AI-driven innovation, a key catalyst underpinning expectations of expanded market opportunity and high-value contracts. Yet, while results looked strong, investors should watch for signs the risk from cloud migration and changing IT standards could test the resilience of NetScout’s core business…

Read the full narrative on NetScout Systems (it’s free!)

NetScout Systems is projected to reach $905.7 million in revenue and $49.6 million in earnings by 2028. This outlook assumes a 2.8% annual revenue growth rate, but reflects a decrease in earnings of $23.2 million from the current $72.8 million.

Uncover how NetScout Systems’ forecasts yield a $30.42 fair value, a 6% upside to its current price.

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Explore 2 other fair value estimates on NetScout Systems – why the stock might be worth as much as 84% more than the current price!

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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.

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(Bloomberg) — A rare thing is about to happen in the $55 billion market for catastrophe bonds: a trigger event will wipe out 100% of a bond’s principal.

Jamaica’s $150 million cat bond has been the subject of controversy since it failed to trigger last year after Hurricane Beryl destroyed large parts of the island. The development sparked calls for a fundamental rethink of the suitability of such financial instruments for developing countries on the frontlines of climate change.

Investors in cat bonds are now hoping that the trigger event forced by Melissa — a massive category 5 hurricane — will finally put such doubts to rest.

“It’s actually a good thing that this bond pays out,” Dirk Schmelzer, senior fund manager at Plenum Investments AG, a holder of Jamaica’s cat bond, said in an interview. “It shows how cat bond structures can help support countries get back on their feet again.”

But skepticism toward the instruments persists.

It took a “black swan” event to trigger the bond, says Jwala Rambarran, a former governor of the central bank of Trinidad and Tobago. “Melissa supersedes everything.”

Rambarran is the co-author of a report by the Vulnerable Twenty Group, or V20 — a collection of nations most exposed to climate change — that last year called for an in-depth reappraisal of sovereign cat bonds. After Beryl, V20 warned that the bonds were becoming increasingly rigid in their structure, with narrow parameters that were shielding investors without helping poorer populations.

Catastrophe bonds are used by issuers — mostly insurers but sometimes also governments — to transfer risk to capital markets. Bondholders risk losses if a predefined catastrophe occurs, but also face sizable returns if it doesn’t. Jamaica agreed to pay investors in its bond a floating rate of 7% above US money market rates.

The last time a weather-related cat bond paid out in full was in connection with Hurricane Ian in 2022. The Swiss Re Global Cat Bond Index slipped about 2% that year, but has since delivered record gains. In the three years since Ian, the Swiss Re index has soared 60%.

Jamaica has what is probably the most robust disaster-financing program of all Caribbean nations. In addition to the $150 million it will get from its cat bond, it can tap $300 million in contingent credit from the Inter-American Development Bank and draw a $92 million payout from a parametric insurance program.

The insured costs of Hurricane Melissa’s damages to onshore property in Jamaica now range between $2.2 billion and $4.2 billion, according to data firm Verisk Analytics Inc. The actual cost, however, will be much higher with less than 20% of the Caribbean island’s residential properties insured, and a significant share lacking sufficient insurance, according to Verisk.

The funds being made available to Jamaica via its cat bond and other instruments “will never be enough to do the restoration and even to do the relief work right now,” Dana Morris Dixon, minister of education, skills, youth and information, said in a briefing on Oct. 31.

At the World Bank, which handled the issuance of Jamaica’s cat bond, Vice President and Treasurer Jorge Familiar said the island’s “comprehensive disaster risk management strategy and proactive approach serve as a model for countries facing similar threats and seeking to strengthen their financial resilience to natural disasters.”

The payout “underscores the role of catastrophe bonds in effective risk management strategies and their efficiency in transferring disaster risks to capital markets,” he said.

But Rambarran says that for highly destructive storms such as Beryl, the risk remains that cat bond triggers are “too hard and specific.” He says “we still need to continue to look at their design and strike a balance between providing a return and doing good.”

Meanwhile, investors exposed to Jamaica’s cat bond are unlikely to suffer any meaningful hits to their portfolios, according to Mara Dobrescu, director of fixed income strategies at Morningstar.

“No one had a huge amount” of Jamaica’s cat bond in their portfolio, she said. So investors will easily absorb any Melissa-related losses and continue to have “a stand-out year.”

At Plenum, the expectation is that losses associated with its holding of the Jamaica bond will leave a dent of only 0.23% on one of its two cat bond funds, while the other will be untouched. The asset manager has no plans to scale back its interest in World Bank-backed issuances, Schmelzer said.

“From an ESG perspective we have a lot of clients who like to see these transactions in the portfolio,” he said. “Losses are losses, but this is a better loss than other ones.”

Major holders of Jamaica’s catastrophe bond include Stone Ridge Asset Management LLC of New York, UK-based Baillie Gifford & Co., and Schroders, according to data compiled by Morningstar.

Stone Ridge didn’t respond to requests for comment. Spokespeople for Baillie Gifford and Schroders declined to comment.

The extent to which vulnerable nations should rely on capital markets to help deal with extreme weather looks set to shape the COP30 talks in Brazil. Such questions also feed into the so-called Baku-to-Belem Roadmap (a reference to Conference of the Parties summits in 2024 and 2025), which seeks to mobilize $1.3 trillion annually for developing countries.

A study published in 2024 found that three years after hurricanes hit in the Caribbean basin, debt levels were 18% higher than in a baseline scenario.

In the case of Melissa, “the extent of the destruction is going to be so large that even with the level of pre-arranged financing that Jamaica has, there won’t be enough funds to meet the extent of the loss,” Rambarran said.

Melissa’s impact on Jamaica “puts us in front of a bigger issue,” he said. “We need a global financial architecture that can support these countries in a deeper way.”

–With assistance from Lauren Rosenthal, Brian Eckhouse and Alexandre Rajbhandari.

©2025 Bloomberg L.P.

• Il Trattore (“The Tractor”) styling concept to take pride of place on Agritechnica stand 
• Styling inspired by the original 702, the first full production Fiat tractor    
• Reflects New Holland’s evolution from Fiat roots through Italian design to meet today’s farmers’ needs

New Holland’s heritage of innovation and style will be spotlighted at Agritechnica 2025. The show will see the debut of the T5.120 ‘Il Trattore’ styling concept tractor, celebrating the enduring legacy of research and development, engineering, and design expertise that began with the first Fiat tractor, the Fiat 702, which will be displayed alongside.

The Il Trattore name signifies the importance of streamlined technology that defines the general-purpose tractor which can take on any task, the essence of that first Fiat tractor and of today’s T5 range. The tractor also underlines New Holland’s commitment to crafting farm machinery that blends style and innovation.

Il Trattore is New Holland’s homage to the iconic 702, one of the earliest mass-produced tractors. Developed to address the labor shortages created by World War I, the 702 introduced a design that marked a turning point in agricultural mechanization. With a four-cylinder engine and load-bearing powertrain, it answered the demands from European farmers for mechanical power to ease physical strain and improve agricultural output. Its success helped establish Fiat’s enduring reputation for agricultural excellence alongside that of Italy’s engineers for innovation and design.

Based on the range-topping model designed and manufactured at New Holland’s Jesi factory in Italy, Il Trattore bears striking green and red coloring and styling inspired by the original Fiat 702. A restored 702, on loan from a Bologna-based collector and dating to 1918, will be displayed alongside the one-of-a-kind special-edition, illustrating the sheer level of progress made in engineering technology over the past century. It highlights the influence of this tractor and its heritage on the style and technology that ensure today’s New Holland brand matches the pace of farmers’ advancing demands.

After the 702’s launch in 1918, Fiat continued to innovate, producing iconically styled tractors such as the Piccola of the 1950s. In the 1970s and 1980s, Fiat demonstrated how style could enhance engineering substance, developing the 80 and 90 series in collaboration with renowned Italian styling house Pininfarina. This design philosophy continued through the 1990s into the era of Fiatagri – as the Fiat agricultural business had become – right through until it eventually evolved into today’s New Holland brand.

Today, New Holland carries forward this legacy, blending Italian design heritage with cutting-edge technology to meet the evolving needs of farmers worldwide and underscoring New Holland’s focus on creating machines of which customers can be proud.

“Our styling of Il Trattore was inspired by the simplicity and iconic face of the Fiat 702. We took the essence of the original design and recreated it for today’s farmers while retaining some retro touches,” says David Wilkie, CNH Head of Industrial Design. “From the Fiat graphic on the front grille to the saddle leather toolbox and seat, there is a wonderful link through form, color and materials in these two iconic designs. It’s been wonderful to be able to reimagine such an important machine and celebrate the essence of ‘Made in Italy’.”

Sobi® (STO: SOBI) today announced that, the TIMI Study Group today has presented positive results from the pivotal Phase 3 CORE and CORE2 studies of olezarsen in people with severe hypertriglyceridemia (sHTG) at the American Heart Association 2025 Scientific Sessions. The studies met the primary endpoint, with olezarsen achieving a highly statistically significant placebo-adjusted mean reduction in fasting triglyceride (TG) levels of up to 72% at six months. The reductions were sustained through 12 months.

• Up to 72% placebo-adjusted mean reduction in fasting triglyceride levels at six months, with reductions sustained through 12 months

• 86% of olezarsen-treated patients achieved triglyceride levels less than 500 mg/dL

• First investigational treatment for sHTG to significantly reduce acute pancreatitis events

• Data simultaneously published in The New England Journal of Medicine

Olezarsen showed a highly statistically significant 85% reduction in acute pancreatitis events, the first time this has been achieved in sHTG. Additionally, 86% of olezarsen-treated patients achieved triglyceride levels less than 500 mg/dL. Olezarsen demonstrated favorable safety and tolerability.

In CORE and CORE2 43% of patients had extremely high levels of triglycerides ≥880 mg/dL, which is often equated to multifactorial chylomicronemia syndrome (MCS) due to the associated increased accumulation of chylomicrons. The effect on triglyceride-lowering and reduction in acute pancreatitis in the MCS subgroup were in line with the overall population.

These data were presented today during a late-breaking session at the American Heart Association (AHA) Scientific Sessions, taking place November 7-10 in New Orleans, and simultaneously published in The New England Journal of Medicine. 

“CORE and CORE2 are the first studies to show a significant reduction in acute pancreatitis events in sHTG, with most patients on olezarsen achieving triglyceride levels below the risk threshold for these potentially life-threatening episodes,” said Nicholas Marston, M.D., M.P.H, presenting author, cardiologist, Brigham and Women’s Hospital, Harvard Medical School. “As a lipid specialist who takes care of sHTG patients, I have seen the major consequences of acute pancreatitis, including cases with recurrent events requiring frequent hospitalizations. Given the modest effects of conventional therapies, these impactful data are a welcome advance.” 

“We are highly encouraged by the CORE and CORE2 results showing that olezarsen can help most patients with severe hypertriglyceridemia achieve safer triglyceride levels and significantly reduce their risk of acute pancreatitis,” said Lydia Abad-Franch, Head of R&D and Chief Medical Officer of Sobi. “It confirms our belief in the promise of olezarsen in a broader patient group and offers new hope for a tangible improvement in quality of life for those who have long struggled with limited treatment options. Sobi is moving forward with the European submission for olezarsen in MCS which we are planning for next year.” 

Nearly 1,100 patients were enrolled in the CORE and CORE2 studies, which is the largest pivotal program ever conducted in sHTG, and patients were required to be on standard of care lipid-lowering therapy. The two phase 3, randomized, double-blind, placebo-controlled CORE and CORE2 trials assessed the impact of olezarsen SC every 4 weeks on fasting plasma TG levels and rates of acute pancreatitis in 617 and 446 patients with severe hypertriglyceridemia (sHTG, fasting plasma TG levels ≥ 500 mg/dL).

The CORE and CORE2 studies met the primary endpoint across doses, with olezarsen demonstrating an up to 72% (p<0.001) placebo-adjusted mean reduction in fasting triglyceride levels at six months. The reductions were sustained through 12 months. Olezarsen demonstrated a highly statistically significant 85% reduction in adjudicated acute pancreatitis events at 12 months (p<0.001). These results were based on a total of 22 events in 17 patients in the placebo group, compared to seven events in five patients in the olezarsen group (pooled 50 mg and 80 mg dose groups). 

Olezarsen demonstrated a favourable safety and tolerability profile in the CORE and CORE2 studies. Adverse events were balanced across treatment arms (75% olezarsen 50 mg; 76% olezarsen 80 mg; 75% placebo). Serious adverse events occurred less frequently in the olezarsen group compared to placebo (9% olezarsen 50 mg; 11% olezarsen 80 mg; 14% placebo). The most common treatment-emergent events were injection site reactions, which were mostly mild and occurred more frequently with olezarsen (10% olezarsen 50 mg; 17% olezarsen 80 mg; 1% placebo). 

An open-label extension (OLE) study of olezarsen for sHTG is ongoing. More than 90% of patients who completed CORE and CORE2 chose to continue into the OLE. 

Sobi is preparing to submit a marketing authorisation application for olezarsen in MCS to EMA in 2026. Its partner Ionis is on track to submit a supplemental new drug application for sHTG to the FDA by the end of this year.

About the CORE and CORE2 Studies

CORE (NCT05079919; n=617) and CORE2 (NCT05552326; n=446), conducted with The TIMI Study Group, are Phase 3 global, multicenter, randomized, double-blind, placebo-controlled trials investigating the safety and efficacy of olezarsen for severe hypertriglyceridemia (sHTG). Participants aged 18 and older with triglyceride levels ≥500 mg/dL were enrolled. Participants were required to be on standard of care therapies for elevated triglycerides. At baseline, 43% of participants had baseline fasting triglycerides ≥880 mg/dL. Participants were randomized to receive 50 mg or 80 mg of olezarsen or placebo every 4 weeks via subcutaneous injection for 12 months. The primary endpoint is the percent change from baseline in fasting triglycerides at six months compared to placebo. 

About Severe Hypertriglyceridemia (sHTG) and Multifactorial Chylomicronemia Syndrome (MCS)

Severe hypertriglyceridemia (sHTG) is defined by severely high triglycerides (≥500 mg/dL) and characterized by an increased risk of acute pancreatitis and other morbidities. Considered a medical emergency, acute pancreatitis causes debilitating abdominal pain that often requires prolonged hospitalization, can lead to permanent organ damage and can become life-threatening. Preventing the first attack is key. In people with triglycerides ≥880 mg/dL and/or a history of acute pancreatitis episodes, the risk of future attacks is even greater. Triglyceride levels ≥880 mg/dL are often equated to multifactorial chylomicronemia syndrome (MCS) due to the increased accumulation of chylomicrons at these extremely high triglyceride levels. Current standard of care therapies for sHTG or MCS and lifestyle modifications (such as diet and exercise) do not sufficiently or consistently lower triglyceride levels or reduce the risks in all patients. Approximately 2 million people are living with sHTG in the EU5, including approximately 700,000 who are considered having MCS. 

About Olezarsen and the Sobi-Ionis partnership

Olezarsen is an investigational RNA-targeted medicine being evaluated for the treatment of sHTG. Olezarsen is designed to lower the body’s production of apoC-III, a protein produced in the liver that regulates triglyceride metabolism in the blood. Olezarsen is approved in the U.S. and the European Union as TRYNGOLZA® for adults with familial chylomicronemia syndrome (FCS).   

Olezarsen is being developed by Ionis Pharmaceuticals, Inc. Sobi and Ionis have entered into a license agreement under which Sobi receives exclusive rights in countries outside the U.S., Canada, and China to commercialise olezarsen as a potential treatment for familial chylomicronemia syndrome (FCS) and severely elevated triglycerides.

Sobi®

Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.

Contacts

For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.