Category: 3. Business

• Exclusive collaboration will deliver a creative interior design for the Bombardier Global 8000 aircraft, leveraging both companies’ craftsmanship mastery
• Bespoke interior design will be unveiled in 2026 and available for Global 8000 customers to purchase
• The Global 8000⁽¹⁾ is a no-compromise business aircraft, delivering the fastest speed and best field performance to operate from short runways in all weather conditions. It also offers the lowest cabin altitude in the industry, as well as the longest range in its class

Bombardier and ELIE SAAB are proud to announce a collaboration to create a uniquely elegant passenger cabin design for the Bombardier Global 8000⁽¹⁾ aircraft. This creative collaboration brings together two masters of their craft, with Bombardier’s leading aviation expertise and ELIE SAAB’s world-renowned artistry in haute couture and design. Centered on delivering an exceptional passenger experience, the ELIE SAAB-designed jet will combine refined aesthetics, exceptional craftsmanship and innovative functionality, creating an environment where comfort and elegance seamlessly meet. 

This marks Bombardier’s first-ever design collaboration with a luxury fashion house such as ELIE SAAB, underscoring its commitment to providing its customers with the ultimate in personalization and sophistication. Customers of the Global 8000 will have the unique opportunity to select the ELIE SAAB design, a statement of elegance and refinement. The design will be presented at an official unveiling, which will be held in 2026. 

“Bombardier Global 8000 customers are already enjoying the finest in business aviation with exceptional comfort, the fastest speed and lowest cabin altitude in the industry, as well as the best field performance to operate from short runways in all weather conditions. This collaboration with ELIE SAAB further sets apart this aircraft’s distinctive characteristics and exemplifies Bombardier’s commitment to offering a unparallelled customer experience,” said Éric Martel, President and CEO, Bombardier. “As two iconic family businesses and two world-class brands, we share a profound commitment to heritage and excellence, driven by our talented teams and fueled by a spirit of innovation. By combining our engineering and craftsmanship expertise with ELIE SAAB’s iconic design vision, we are offering our customers something truly unique – an aircraft that reflects the pinnacle of elegance and a spectacular attention to detail.”

“Partnering with Bombardier marks an important milestone in ELIE SAAB’s strategic expansion into lifestyle. Together, as two businesses united by family values and a commitment to excellence, we are shaping a new expression of luxury in aviation. By bringing our craftsmanship into dialogue with Bombardier’s engineering mastery, we are creating an experience designed for a global clientele seeking unparalleled refinement and comfort. This vision comes to life in the Global 8000 cabin design, where our signature aesthetic meets Bombardier’s performance leadership to set a new standard for sophistication in air travel,” commented Elie Saab Junior, Vice Chairman and CEO of ELIE SAAB Group.

The Bombardier Global 8000 is the industry’s no-compromise flagship aircraft, setting a new standard for performance, comfort, and innovation. With a top speed of Mach 0.95, an impressive range of 8,000 nautical miles and the lowest cabin altitude in the industry, the Global 8000 redefines long-distance travel. Its advanced technology, smooth ride, and meticulously configurated cabin make it the ultimate choice for those who demand excellence without compromise. Thanks to its exceptional field performance, the Global 8000 also provides access to more airports with shorter runways, offering unmatched flexibility for travelers.

About Bombardier

At Bombardier (BBD-B.TO), we design, build, modify and maintain the world’s best-performing aircraft for the world’s most discerning people and businesses, governments and militaries. That means not simply exceeding standards, but understanding customers well enough to anticipate their unspoken needs. 

For them, we are committed to pioneering the future of aviation—innovating to make flying more reliable, efficient and sustainable. And we are passionate about delivering unrivaled craftsmanship and care, giving our customers greater confidence and the elevated experience they deserve and expect. Because people who shape the world will always need the most productive and responsible ways to move through it.

Bombardier customers operate a fleet of more than 5,100 aircraft, supported by a vast network of Bombardier team members worldwide and 10 service facilities across six countries. Bombardier’s performance-leading jets are proudly manufactured in aerostructure, assembly and completion facilities in Canada, the United States and Mexico. In 2024, Bombardier was honoured with the prestigious “Red Dot: Best of the Best” award for Brands and Communication Design.   

For Information

For corporate news and information, including Bombardier’s Sustainability report, as well as the company’s initiative to cover all its flight operations with a Sustainable Aviation Fuel (SAF) blend utilizing the Book-and-Claim system visit
bombardier.com.

Learn more about Bombardier’s industry-leading products and customer service network at bombardier.com. Follow us on X @Bombardier.

About ELIE SAAB

Founded in Lebanon in 1982, ELIE SAAB is one of the world’s leading Haute Couture lifestyle brands. As one of the first international members of France’s prestigious Chambre Syndicale, the House has established a global presence with flagship boutiques in major fashion capitals including Paris, London, Milan, Dubai, Beirut and other key cities around the world. 

Sought after by A-list celebrities and royalty around the globe, the house offers Haute Couture, Ready-to-Wear, and Bridal collections, complemented by accessories, eyewear, childrenswear, watches, fragrances and furniture. The brand has also expanded into interior design partnering with leading developers worldwide.

Media Contacts

General media contact webform

Christina Lemyre McCraw
+1-514-497-4928
christina.lemyremccraw@aero.bombardier.com

Bombardier, Global and Global 8000 are registered or unregistered trademarks of Bombardier Inc. or its subsidiaries.

⁽¹⁾ The Global 8000 aircraft received Transport Canada Type Certification on November 5, 2025; certification from the U.S. Federal Aviation Administration and from the European Aviation Safety Agency is pending. All specifications and data are subject to certain operating rules, assumptions and other conditions. It is expected to enter into service in 2025. Please also see the forward-looking statements disclaimer at the end of this press release.

Forward-looking statements
This press release contains certain forward-looking statements. By their nature, forward-looking statements require the Corporation to make assumptions and are subject to important known and unknown risks and uncertainties, which may cause actual results in future periods to differ materially from those set forth in the forward-looking statements. Please refer to the “Forward-Looking Statements” disclaimer contained in Bombardier Inc.’s most recently published financial report for additional details.

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UBS chair Colm Kelleher and US Treasury secretary Scott Bessent have privately discussed moving the bank’s headquarters to the US, as the Zurich-based lender explores contingency plans to leave Switzerland if the government does not back down on new capital rules. 

Kelleher and Bessent held talks in recent months about what a move to the US would look like for the lender, with the Trump administration receptive to welcoming one of Switzerland’s most prized assets, according to three people familiar with the conversation. 

The talks with Bessent are part of an ongoing effort by Kelleher to put pressure on the Swiss government over proposed capital requirements that would force UBS to hold an additional $26bn of capital, a move UBS has described as “extreme” and disproportionate. 

The uncertainty surrounding the planned changes has weighed on the bank’s share price, and a public and private lobbying campaign by the lender’s management has so far yielded few results. 

UBS has argued that the new requirements go further than those required of global peers and would reduce its ability to compete internationally. 

Meanwhile, the Swiss government has said it needs to shore up the country’s banking system to avoid another Credit Suisse-style collapse. UBS acquired its crosstown rival in 2023 in a state-orchestrated rescue. 

“As we have said repeatedly, we want to continue to operate successfully as a global bank out of Switzerland,” UBS said.

US regulators have been wary of large lenders redomiciling in the country, given public anger over taxpayer-funded bailouts of banks during the financial crisis. However, the Trump administration has been more open to the idea of attracting European financial institutions.

UBS executives want the bank’s headquarters to remain in Switzerland if they can convince parliament to reduce the proposed hit, according to people familiar with their thinking. However, they believe they have a fiduciary duty to examine all potential options and are open to the idea of leaving if the proposals do not change, the people added. 

Activist investor Cevian Capital, which has a sizeable stake in UBS, said in September that the proposed Swiss capital changes would make it “not viable” to run a large international bank from the country. It added that UBS would have “no other realistic option” but to leave Switzerland if the proposals were not watered down. 

The intervention by Europe’s largest dedicated activist investor added weight to the idea that UBS could move its headquarters out of Switzerland, an idea that some in the industry view as a negotiating tactic that is unlikely to happen in practice. 

Switzerland’s decision to impose stricter capital rules comes as the US pursues deregulation in various parts of the economy to boost growth and encourage businesses to expand their operations in the country.

The administration has signalled its intent to loosen rules governing banks, with the US Treasury secretary using the growth of private credit as an example that lenders have been “too tightly constrained”. He has also argued in favour of minimising capital and liquidity rules in a bid to free up more space for lending. 

The Trump administration’s push to relax bank rules has sparked concern among European authorities that US deregulation will give American lenders an advantage over transatlantic rivals and create risks for the stability of the global financial system. 

Integration brings ActiveState’s VEX advisories and secure libraries directly into Trivy scans, providing high-fidelity results and faster remediation paths

VANCOUVER, BC and TEL AVIV, Israel, Nov. 17, 2025 /PRNewswire/ — ActiveState, a global leader in open source language solutions and secure software supply chain management, today announced it has joined Trivy Partner Connect, bringing ActiveState’s CVE advisories, secure open source containers, and language libraries to Trivy’s trusted scanning capabilities. This collaboration delivers CVE-free open source directly into the workflows developers already use, helping teams build and ship secure software more efficiently.

ActiveState joins a growing community of organizations collaborating with Aqua to advance Trivy, the world’s most popular open source vulnerability scanner. Together, ActiveState and Trivy help reduce the noise associated with CVE alerts by integrating ActiveState’s advisory feed into the scanning process. Trivy users can now see an accurate risk profile for any ActiveState open source artifacts they use. The advisory feed also includes VEX (Vulnerability Exploitability eXchange) information, enabling Trivy to suppress CVEs that have been fully investigated and deemed non-exploitable by ActiveState. When valid CVEs are found, Trivy users will also receive remediation options provided by ActiveState for affected containers and language packages.

Through this integration, users will have the most up-to-date information verified by both parties. This collaboration extends the value of Trivy Partner Connect, making it easier for organizations to ensure their open source components are secure, compliant, and production ready.

“ActiveState’s participation in Partner Connect brings their deep expertise in the open source supply chain directly to the Trivy community,” said Matt Richards, CMO at Aqua Security. “By combining ActiveState’s advisories, trusted libraries and secure containers with Trivy’s powerful scanning, developers get the best of both worlds: high-quality, vetted components and reliable, high-fidelity validation. This is a big step forward for developer-first security and supply chain integrity.”

Recent industry research¹ shows that 86% of commercial code bases contain open source vulnerabilities and 81% contain high or critical CVEs. ActiveState found that researching the potential impact of CVEs consumes about 26% of the overall vulnerability discovery-to-remediation process. This involves hands-on research to understand if the vulnerability is reachable and exploitable, and then determining the next step based on those findings (remediate or VEX). The integration between Trivy and ActiveState aims to reduce time spent researching vulnerabilities, giving developers back time to focus on delivering innovation.

“Partnering with Trivy underscores our shared commitment to enabling and securing open source in enterprise applications,” said Stephen Baker, CEO of ActiveState. “Our mission at ActiveState is to provide developers with a trusted, ‘paved path’ for open source, eliminating the complexity, risk, and manual vetting associated with securing the supply chain. This collaboration enables developers to confidently build applications using secure, curated components that are validated by Trivy, allowing them to maintain speed, compliance, and trust in their open source.”

Learn More
Organizations can explore ActiveState’s Trivy-integrated secure open source containers and language libraries at https://trivy.dev/partners or activestate.com. Trivy Partner Connect is open and expanding quickly. Organizations interested in joining can learn more and apply at Trivy Partner Connect.

About ActiveState
ActiveState enables DevOps, InfoSec, and Development teams to improve their security posture while simultaneously increasing productivity and innovation to deliver secure applications faster. We are the only solution in the market today that offers vulnerability-free open source language packages and containers and Intelligent Remediation, which identifies which vulnerabilities to prioritize, assesses the impact of updates causing breaking changes, prioritizes what to fix first, securely builds open source packages from source, and facilitates the build and deploy process to get fixes into production quickly and easily. All from the trusted partner that pioneered and continues to lead enterprise adoption and use of open source software.

About Aqua Trivy
Trivy is the most popular open source scanner for containers, IaC, code, cloud, and Kubernetes, detecting vulnerabilities, misconfigurations, and secrets. Trusted by millions worldwide, Trivy is maintained by Aqua Security. Learn more at https://trivy.dev/.

About Aqua Security
Aqua Security protects every cloud native application from code to cloud to prompt. As the pioneer in container security and vulnerability management, Aqua delivers full protection across the application lifecycle in real time. Our unified CNAPP combines agentless and agent-based controls with industry-leading runtime security for cloud, on-prem, hybrid, multi-cloud, VM and mainframe environments. The Aqua Platform provides best-in-class security agents and advanced contextual analysis to reduce noise and accelerate remediation. Founded in 2015, Aqua is headquartered in Boston, MA and Ramat Gan, Israel and secures more than 40% of the Fortune 100. Learn more at aquasec.com.

¹ https://news.blackduck.com/2025-02-25-New-Black-Duck-Report-86-of-Commercial-Codebases-Contain-Vulnerable-Open-Source,-Exposing-Organizations-to-Security-Risks

SOURCE ActiveState

The Central Bank of Ireland (CBI) has imposed sanctions on crypto-asset service provider Coinbase Europe for contraventions of the Criminal Justice (Money Laundering and Terrorist Financing) Act 2010, which occurred between 23 April 2021 and 19 March 2025.

The sanctions imposed by the CBI include a reprimand and a monetary penalty in the amount of €30,663,906, – reduced to €21,464,734 after a settlement scheme discount was applied. The sanctions relate to failures to uphold anti-money laundering and counter terrorist financing monitoring obligations over a twelve-month period.

The sanctions require confirmation of the Irish High Court before taking effect, and would be the fourth largest fine ever issued by the CBI.

Coinbase Europe is part of the global Coinbase Group, which operates a significant global trading platform for crypto assets. In April 2021, it became a “designated person” under the CJA 2010 and was registered as a virtual asset service provider (VASP) with the CBI in December 2022, meaning it was required to monitor transactions for anti-money laundering and counter-terrorist financing purposes.

Where Coinbase suspects that a transaction is facilitating anti-money laundering or counter-terrorist financing, it must make a suspicious transaction report (STR) to the Financial Intelligence Unit of the Garda National Economic Crime Bureau (GNECB) and the Revenue Commissioners as soon as possible.

However, due to technical faults in the configuration of Coinbase’s transaction monitoring system, more than 30 million transactions were not properly monitored over a 12 month period. The value of these transactions amounted to €176 billion. The company took three years to fully complete the proper monitoring of the transactions, resulting in the filing of 2,708 STRs with the GNECB.

Sarah Twohig, a crypto fraud and enforcement specialist with Pinsent Masons in Dublin, said the fine should send a signal to others in the industry of their obligations.

“The enforcement action taken by the Central Bank of Ireland against Coinbase Europe is a reminder of the significant impact a failure to comply with anti-money laundering and counter terrorist financing obligations can have on all businesses that operate in the financial services industry,” she said.

“Businesses such as crypto exchanges and virtual asset service providers must prioritise these obligations, to ensure that the monitoring of assets in their custody is carried out in real time, so that it can be verified that such assets are not the proceeds of crypto fraud and are not being used for money-laundering purposes.” 

As part of a settlement with the CBI (PDF, 543kb/36 pages), Coinbase Europe agreed it had failed to properly monitor 30,442,437 transactions during the 12-month period, and failed to conduct increased monitoring of 184,790 of these transactions.

It also accepted it had not adopted required internal policies and procedures to prevent and detect money laundering and terrorist financing.

The Central Bank of Ireland said the suspicious transactions were associated with serious criminal activities – including money laundering, drug trafficking, cyber attacks and child sexual exploitation.  The fine is the first imposed on a regulated entity in the crypto industry by the regulator.

Colm Kincaid, deputy governor for consumer and investor protection with the Central Bank, said: “Crypto has particular technological features which, together with its anonymity-enhancing capabilities and cross-border nature, makes it especially attractive to criminals looking to move their funds.

“This is why it is especially important that firms engaged in crypto services have robust controls in place to identify and report suspicious transactions.”

Artificial intelligence companies must be transparent about the risks posed by their products or risk repeating the mistakes of tobacco and opioid companies, according to the chief executive of the AI startup Anthropic.

Dario Amodei, who runs the US company behind the Claude chatbot, said he believed AI will become smarter than “most or all humans in most or all ways” and urged his peers to “call it as you see it”.

Speaking to CBS News, Amodei said a lack of transparency about the impact of powerful AI would replay the errors of cigarette and opioid firms that failed to raise a red flag over the potential health damage of their own products.

“You could end up in the world of, like, the cigarette companies, or the opioid companies, where they knew there were dangers, and they didn’t talk about them, and certainly did not prevent them,” he said.

Amodei warned this year that AI could eliminate half of all entry-level white-collar jobs – office jobs such as accountancy, law and banking – within five years.

“Without intervention, it’s hard to imagine that there won’t be some significant job impact there. And my worry is that it will be broad and it’ll be faster than what we’ve seen with previous technology,” Amodei said.

Anthropic, whose CEO is a prominent voice for online safety, has flagged various concerns about its AI models recently, including an apparent awareness that they are being tested and attempting to commit blackmail. Last week it said its coding tool, Claude Code, was used by a Chinese state-sponsored group to attack 30 entities around the world in September, achieving a “handful of successful intrusions”.

“One of the things that’s been powerful in a positive way about the models is their ability to kind of act on their own,” said Amodei. “But the more autonomy we give these systems, you know, the more we can worry are they doing exactly the things that we want them to do?”

Logan Graham, the head of Anthropic’s team for stress testing AI models, told CBS that the flipside of a model’s ability to find health breakthroughs could be helping to build a biological weapon.

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“If the model can help make a biological weapon, for example, that’s usually the same capabilities that the model could use to help make vaccines and accelerate therapeutics,” he said.

Referring to autonomous models, which are viewed as a key part of the investment case for AI, Graham said users want to an AI tool to help their business – not wreck it.

“You want a model to go build your business and make you a billion,” he said. “But you don’t want to wake up one day and find that it’s also locked you out of the company, for example. And so our sort of basic approach to it is, we should just start measuring these autonomous capabilities and to run as many weird experiments as possible and see what happens.”

As the United States market navigates a mixed landscape with major stock indexes showing varied performances, investors are paying close attention to small-cap stocks, which often hold potential for significant growth despite broader market volatility. In such an environment, identifying promising opportunities requires a focus on companies with strong fundamentals and innovative strategies that can thrive amid economic shifts and evolving investor sentiment.

Click here to see the full list of 294 stocks from our US Undiscovered Gems With Strong Fundamentals screener.

We’ll examine a selection from our screener results.

Simply Wall St Value Rating: ★★★★★☆

Overview: Anterix Inc. specializes in commercializing spectrum assets to facilitate private broadband networks for utility and critical infrastructure sectors, with a market capitalization of $424.31 million.

Operations: Anterix generates revenue primarily from its wireless communications services, amounting to $5.93 million.

Anterix, a small player in the telecom sector, has recently turned profitable with net income of US$53.54 million for Q2 2025 compared to a net loss of US$12.77 million last year. The company is trading at 76% below its estimated fair value and has repurchased 691,534 shares worth US$23.26 million under its buyback program since September 2023. Anterix’s collaboration with Crown Castle on the TowerX initiative aims to expedite the deployment of private LTE networks for utilities, enhancing operational resilience and grid modernization efforts across the U.S., leveraging over 40,000 tower sites nationwide.

Simply Wall St Value Rating: ★★★★★★

Overview: Spok Holdings, Inc., via its subsidiary Spok, Inc., delivers healthcare communication solutions across various regions including the United States, Europe, Canada, Australia, Asia, and the Middle East with a market capitalization of $286.31 million.

Operations: Spok generates revenue primarily from its Clinical Communication and Collaboration business, which recorded $139.74 million. The company’s market capitalization stands at $286.31 million.

Spok Holdings, known for its role in healthcare communications, has embraced a SaaS model that enhances recurring revenue and margin profiles. Despite this strategic shift, the company faces challenges like declining core wireless service revenues and reliance on existing clients. Recent financials show third-quarter sales of US$16.07 million, slightly down from US$16.61 million last year, with net income at US$3.2 million compared to US$3.66 million previously. The firm is debt-free and trades 15% below estimated fair value but saw significant insider selling recently; analysts project modest future growth with a consensus price target of US$21 per share.

Simply Wall St Value Rating: ★★★★★★

Overview: CompX International Inc. is a company that manufactures and sells security products and recreational marine components primarily in North America, with a market cap of $277.88 million.

Operations: CompX International generates revenue primarily from two segments: security products, which contribute $121.76 million, and marine components, accounting for $37.25 million.

CompX International, a nimble player in its sector, showcases strong financial health with no debt over the past five years and high-quality earnings. The company reported third-quarter sales of US$39.95 million, up from US$33.67 million last year, while net income rose to US$4.22 million from US$3.48 million. Basic earnings per share increased to US$0.34 from US$0.28 a year ago, reflecting solid performance amidst industry challenges. With free cash flow remaining positive and trading at 25% below estimated fair value, CompX seems well-positioned for continued stability and potential growth in the commercial services landscape.

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 ATEX SPOK and CIX.

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

Train passengers have been warned of disruption between Plymouth and Penzance due to a collapsed badger sett.

Great Western Railway (GWR) said train movement had been stopped after a collapsing badger sett, a network of tunnels used by the animals, was identified under the rail line in the Hayle area.

The operator said train services would be cancelled, delayed or revised and disruption was expected until midday.

It said rail replacements were in place but that some lines would be “reopened shortly”.

Vicore Pharma Holding AB has carried out a directed new share issue of shares of approximately USD 48 million where the subscription price was set through an accelerated bookbuilding procedure.

Vicore Pharma Holding AB is a clinical-stage pharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential in respiratory and fibrotic diseases, including idiopathic pulmonary fibrosis (IPF). The Company’s lead program, buloxibutid, is a first-in-class oral small molecule angiotensin II type 2 receptor agonist, which has received Orphan Drug and Fast Track designation from the United States Food and Drug Administration and is currently being investigated in the global 52-week Phase 2b ASPIRE trial in IPF. The Company is publicly listed on the Nasdaq Stockholm exchange (VICO).

Jefferies GmbH and Pareto Securities AB acted as Joint Global Coordinators and Joint Bookrunners while Cantor Fitzgerald & Co. acted as Joint Bookrunner. Baker McKenzie acted as legal advisor to Vicore Pharma with an international capital markets team consisting of Henric Roth, Olof Larsson and Thea Hanson in Stockholm as well as Adam Farlow and Charles Farnsworth in London.

Ziihera plus chemotherapy showed a clinically meaningful and statistically significant improvement in PFS versus trastuzumab and chemotherapy, and a clinically meaningful effect with a strong trend toward statistical significance for OS at the first OS interim analysis

Ziihera plus the PD-1 inhibitor Tevimbra ^® (tislelizumab) and chemotherapy demonstrated clinically meaningful and statistically significant improvements in OS and PFS versus trastuzumab and chemotherapy

Company plans to submit a supplemental BLA for this indication in first half of 2026

For U.S. media and investors only  

DUBLIN, Nov. 17, 2025 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced positive top-line results from the Phase 3 HERIZON-GEA-01 trial evaluating Ziihera^® (zanidatamab-hrii) in combination with chemotherapy, with or without the PD-1 inhibitor Tevimbra^® (tislelizumab), as first-line treatment for HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), including cancers of the stomach, gastroesophageal junction and esophagus.

• Both Ziihera plus chemotherapy and Ziihera plus tislelizumab and chemotherapy demonstrated highly statistically significant and clinically meaningful improvements in progression-free survival (PFS) compared to the control arm, trastuzumab plus chemotherapy.
• Ziihera plus tislelizumab and chemotherapy also demonstrated clinically meaningful and statistically significant improvements in overall survival (OS), and Ziihera plus chemotherapy demonstrated a clinically meaningful effect with a strong trend toward statistical significance for OS compared to the control arm at the time of this first analysis. The trial is ongoing with an additional planned OS interim analysis for Ziihera plus chemotherapy currently expected in mid-2026.
• A PFS and OS benefit was observed in the Ziihera plus tislelizumab and chemotherapy arm versus the control arm in both PD-L1 positive and PD-L1 negative subgroups.
• Both Ziihera plus chemotherapy, and Ziihera plus tislelizumab and chemotherapy demonstrated improvements in the key secondary endpoints of objective response rate (ORR) and duration of response (DoR) versus the control arm, and these endpoints were supportive of the primary efficacy endpoints.

“Advanced GEA represents one of the most common tumor types worldwide and remains an aggressive cancer with a poor prognosis,” said Dr. Kohei Shitara, director of the Department of Gastrointestinal Oncology, and principal trial investigator at the National Cancer Center Hospital East, Kashiwa, Japan. “Based on the positive results seen in the HERIZON-GEA-01 trial, the zanidatamab plus chemotherapy combination, with and without tislelizumab, has the potential to become the new standard of care for patients in HER2+ first-line locally advanced unresectable or metastatic GEA. This is the first Phase 3 trial to demonstrate a benefit for a novel HER2-targeted therapy compared to trastuzumab as part of a combination regimen in HER2+ first-line GEA.”

“We believe these results will be practice changing, and highlight the potential impact of Ziihera for patients who are facing a devastating diagnosis and limited options in locally advanced or metastatic GEA,” said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. “We expect Ziihera to become the new standard of care anti-HER2 therapy for patients with HER2+ first-line metastatic GEA regardless of PD-L1 status. We plan to quickly engage FDA and expect to submit a supplemental Biologics License Application (sBLA) in the U.S. in first half of 2026 to support Ziihera as a first-line treatment for patients with HER2+ locally advanced or metastatic GEA for use as part of a standard chemotherapy regimen with and without tislelizumab. We thank the patients and investigators who are involved in this trial.”

The safety profile of Ziihera in combination with chemotherapy, with or without tislelizumab, was generally consistent with the known safety profile of each agent with no new safety signals observed in the two investigational combination arms and supports the overall benefit risk of Ziihera for use in this indication.

Jazz plans to submit these data for presentation at a major medical meeting in the first quarter of 2026 and for publication in a peer-reviewed journal, and will rapidly submit for adoption in the National Comprehensive Cancer Network^® Guidelines (NCCN Guidelines^®).

HERIZON-GEA-01 marks the first Phase 3 trial results for Ziihera. Ongoing research for Ziihera includes the Phase 3 HERIZON-BTC-302 trial evaluating Ziihera and CisGem (cisplatin plus gemcitabine) with or without the addition of a PD-1/L-1 inhibitor versus CisGem with or without a PD-1/L1 inhibitor in adult participants with HER2+ biliary tract cancer; the Phase 3 EmpowHER-303 trial evaluating Ziihera compared to trastuzumab, each in combination with physician’s choice of chemotherapy, for the treatment of participants with metastatic HER2+ breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment; the DiscovHER PAN-206 basket trial evaluating Ziihera monotherapy in previously-treated patients with HER2+ (IHC 3+) cancers; and the Phase 2 EmpowHER-208 trial evaluating Ziihera in patients with HER2+ neoadjuvant and adjuvant breast cancer.

About the HERIZON-GEA-01 Phase 3 Trial
HERIZON-GEA-01 (NCT05152147) is a global, randomized, open-label Phase 3 trial, conducted jointly with BeOne Medicines, to evaluate and compare the efficacy and safety of Ziihera plus chemotherapy, with or without tislelizumab, to the standard of care (trastuzumab plus chemotherapy) as first-line treatment for adult patients with advanced/metastatic HER2+ GEA. The trial randomized 914 patients from approximately 300 trial sites in more than 30 countries. Appropriate patients for this trial had unresectable locally advanced, recurrent or metastatic HER2+ GEA (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Patients were randomized to the three trial arms: Ziihera in combination with chemotherapy and tislelizumab; Ziihera in combination with chemotherapy; and trastuzumab plus chemotherapy. The trial is evaluating dual primary endpoints, PFS per blinded independent central review (BICR) and OS.

About Gastroesophageal Adenocarcinoma 
Gastroesophageal adenocarcinoma (GEA), including cancers of the stomach, gastroesophageal junction, and esophagus, is the fifth most common cancer worldwide, and approximately 20% of patients have HER2+ disease.^1,2,3 HER2+ GEA has high morbidity and mortality, and patients are urgently in need of new treatment options. The overall prognosis for patients with GEA remains poor, with a global five-year survival rate of less than 30% for gastric cancer and about 19% for GEA.⁴

About Ziihera^® (zanidatamab-hrii)  
Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.⁵ In the United States, Ziihera is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.⁵ The U.S. FDA granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).⁵ 

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule.   

The FDA granted Breakthrough Therapy designation for zanidatamab’s development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from the FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer.   

Important Safety Information for ZIIHERA  

WARNINGS AND PRECAUTIONS 

Embryo-Fetal Toxicity 

ZIIHERA can cause fetal harm when administered to a pregnant woman. In literature reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. 

Verify the pregnancy status of females of reproductive potential prior to the initiation of ZIIHERA. Advise pregnant women and females of reproductive potential that exposure to ZIIHERA during pregnancy or within 4 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment with ZIIHERA and for 4 months following the last dose of ZIIHERA. 

Left Ventricular Dysfunction 

ZIIHERA can cause decreases in left ventricular ejection fraction (LVEF). LVEF declined by >10% and decreased to <50% in 4.3% of 233 patients. Left ventricular dysfunction (LVD) leading to permanent discontinuation of ZIIHERA was reported in 0.9% of patients. The median time to first occurrence of LVD was 5.6 months (range: 1.6 to 18.7). LVD resolved in 70% of patients. 

Assess LVEF prior to initiation of ZIIHERA and at regular intervals during treatment. Withhold dose or permanently discontinue ZIIHERA based on severity of adverse reactions. 

The safety of ZIIHERA has not been established in patients with a baseline ejection fraction that is below 50%. 

Infusion-Related Reactions 

ZIIHERA can cause infusion-related reactions (IRRs). An IRR was reported in 31% of 233 patients treated with ZIIHERA as a single agent in clinical studies, including Grade 3 (0.4%), and Grade 2 (25%). IRRs leading to permanent discontinuation of ZIIHERA were reported in 0.4% of patients. IRRs occurred on the first day of dosing in 28% of patients; 97% of IRRs resolved within one day. 

Prior to each dose of ZIIHERA, administer premedications to prevent potential IRRs. Monitor patients for signs and symptoms of IRR during ZIIHERA administration and as clinically indicated after completion of infusion. Have medications and emergency equipment to treat IRRs available for immediate use. 

If an IRR occurs, slow, or stop the infusion, and administer appropriate medical management. Monitor patients until complete resolution of signs and symptoms before resuming. Permanently discontinue ZIIHERA in patients with recurrent severe or life-threatening IRRs. 

Diarrhea 

ZIIHERA can cause severe diarrhea. 

Diarrhea was reported in 48% of 233 patients treated in clinical studies, including Grade 3 (6%) and Grade 2 (17%). If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Withhold or permanently discontinue ZIIHERA based on severity. 

ADVERSE REACTIONS 

Serious adverse reactions occurred in 53% of 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA. Serious adverse reactions in >2% of patients included biliary obstruction (15%), biliary tract infection (8%), sepsis (8%), pneumonia (5%), diarrhea (3.8%), gastric obstruction (3.8%), and fatigue (2.5%). A fatal adverse reaction of hepatic failure occurred in one patient who received ZIIHERA. 

The most common adverse reactions in 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA (≥20%) were diarrhea (50%), infusion-related reaction (35%), abdominal pain (29%), and fatigue (24%). 

USE IN SPECIFIC POPULATIONS 

Pediatric Use 

Safety and efficacy of ZIIHERA have not been established in pediatric patients. 

Geriatric Use 

Of the 80 patients who received ZIIHERA for unresectable or metastatic HER2-positive BTC, there were 39 (49%) patients 65 years of age and older. Thirty-seven (46%) were aged 65-74 years old and 2 (3%) were aged 75 years or older. 

No overall differences in safety or efficacy were observed between these patients and younger adult patients. 

The full U.S. Prescribing Information for ZIIHERA, including BOXED Warning, is available at: https://pp.jazzpharma.com/pi/ziihera.en.USPI.pdf 

® TEVIMBRA (tislelizumab) is a registered trademark of BeOne Medicines.

About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing potentially life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. 

Jazz Pharmaceuticals plc Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to Ziihera’s potential as a new standard of care in HER2+ first-line GEA and other HER2-expressing cancers, expected timing of OS data from the pivotal Phase 3 HERIZON-GEA-01, plans to submit a sBLA in first half of 2026 and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals’ current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the successful completion of regulatory activities and uncertain regulatory approval, risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients and other risks and uncertainties affecting Jazz Pharmaceuticals and its development programs, including those described from time to time under the caption “Risk Factors” and elsewhere in Jazz Pharmaceuticals plc’s Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including Jazz Pharmaceuticals’ Annual Report on Form 10-K for the year ended December 31, 2024, as supplemented by Jazz Pharmaceuticals’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, and future filings and reports by Jazz Pharmaceuticals. Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect Jazz Pharmaceuticals’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise. Jazz Pharmaceuticals undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made. 

Contacts:

Media Contact:
Kristin Bhavnani
Head of Global Corporate Communications
Jazz Pharmaceuticals plc
[email protected]
Ireland +353 1 637 2141
U.S. +1 215 867 4948

Jazz Investor Contact:
Jack Spinks
Executive Director, Investor Relations
Jazz Pharmaceuticals plc
[email protected]
Ireland +353 1 634 3211
U.S. +1 650 496 2717

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¹ Abrahao-Machado I.F., et al. HER2 testing in gastric cancer: An update WorldJGastroenterol. 2016;22(19):4619-4625.
² Van Custem E., et al. HER2 screening data from ToGA: targeting HER2 in gastric and gastroesophageal junction cancer. Gastric Cancer. 2015;18(3):476-484.
³ Stroes, C.I., et al. A systematic review of HER2 blockade for the curative treatment of gastroesophageal adenocarcinoma: Successes achieved and opportunities ahead. CancerTreatRev. 2021;99:102249.
⁴ Battaglin F, et al. Molecular biomarkers in gastro-esophageal cancer: recent developments, current trends and future directions. Cancer Cell International. 2018;18(99). 
⁵ ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.)

SOURCE Jazz Pharmaceuticals plc