Market Signal Briefing

9h35 ▪
4
min read ▪ by
Luc Jose A.

Summarize this article with:

XRP is making an unexpected breakthrough in regulated markets. Driven by a record third quarter for the CME, derivatives linked to the asset are exploding, attracting a massive influx of institutional investors. Volumes soaring, open interest at its highest: the XRP futures market reaches unprecedented levels. This dynamic, far from a mere passing craze, marks a strategic turning point for cryptos outside the BTC/ETH duo. A new era opens, where alternative assets gain legitimacy in traditional financial circuits.

In Brief

XRP records a spectacular breakthrough in regulated markets, driven by a record quarter for the CME.
More than 476,000 XRP futures contracts have been traded since May 2025, totaling 23.7 billion dollars.
Open Interest reaches 1.4 billion dollars and the number of large institutional investors sets a record at 29.
CME plans to launch trading starting in 2026, aligning regulated markets with the native functioning of crypto.

XRP Joins the Big Leagues on the CME
Since their launch last May, XRP futures contracts have triggered unprecedented enthusiasm, especially from institutional investors.

The CME Group, in its Crypto Insights October report, reports that the XRP derivative product range, including Futures and Micro Futures, has quickly gained adoption, reaching record levels within a few months.

The institution notes : “the third quarter showed a strong rise in demand for regulated crypto exposures, with futures contracts on Solana (SOL) and XRP reaching historic highs”.

The published data is unequivocal and highlights the scale of the phenomenon :

476,000 XRP contracts have been traded since May ;
A total notional value of 23.7 billion dollars has been reached ;
Open Interest peaked at 1.4 billion dollars in September ;
The number of large open interest holders (LOIH) reached 29, an absolute record for XRP products on the CME.

This spectacular surge reflects a trend linked to the gradual shift of some institutional investors towards alternative assets to bitcoin and Ethereum, provided they are accessible through regulated products.

The XRP case is even more notable as it was long perceived as a legally uncertain asset. The fact that it now finds its place in institutional portfolios via regulated derivatives indicates a strategic repositioning of these actors in front of a market undergoing diversification.

The CME Capitalizes on the Enthusiasm for Regulated Assets
Beyond the specific performance of XRP contracts, it is the entire CME crypto derivatives market that reached a historic peak in the third quarter.

Indeed, the CME recorded more than 900 billion dollars in combined volume on crypto futures and options. The average daily Open Interest climbed to 31.3 billion dollars, and the total number of LOIH now stands at 1,014, marking an institutional participation never seen before. These figures reflect a structural shift in the engagement of professional investors in regulated crypto markets.

To support this momentum, the CME launched on October 13 the first options on XRP and Solana approved by the CFTC, the only ones currently authorized in the United States for these assets. The group also plans to go further, with the trading launch scheduled for early 2026, to align its hours with the uninterrupted nature of digital markets. “These are the only XRP and Solana options approved by the CFTC in the US, offering a trusted platform for efficient capital trading”, the official statement emphasizes.

This acceleration reveals several implications for the market. In the short term, it confirms the rise of a regulated ecosystem no longer limited to the two heavyweights bitcoin and Ethereum. In the medium term, the CME seems to position itself as a strategic bridge between traditional financial infrastructures and the crypto universe. By adopting a more flexible model, it adapts to the standards of Web3 while meeting the demands of Wall Street.

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Luc Jose A.

Diplômé de Sciences Po Toulouse et titulaire d'une certification consultant blockchain délivrée par Alyra, j'ai rejoint l'aventure Cointribune en 2019.
Convaincu du potentiel de la blockchain pour transformer de nombreux secteurs de l'économie, j'ai pris l'engagement de sensibiliser et d'informer le grand public sur cet écosystème en constante évolution. Mon objectif est de permettre à chacun de mieux comprendre la blockchain et de saisir les opportunités qu'elle offre. Je m'efforce chaque jour de fournir une analyse objective de l'actualité, de décrypter les tendances du marché, de relayer les dernières innovations technologiques et de mettre en perspective les enjeux économiques et sociétaux de cette révolution en marche.

DISCLAIMER

The views, thoughts, and opinions expressed in this article belong solely to the author, and should not be taken as investment advice. Do your own research before taking any investment decisions.

Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

, /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, reminds investors of a class action lawsuit against MoonLake Immunotherapeutics ("MoonLake" or "the Company") (NASDAQ: MLTX) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.

Investors who purchased the Company's securities between March 10, 2024 and September 29, 2025, inclusive (the "Class Period"), are encouraged to contact the firm before December 15, 2025.

If you are a shareholder who suffered a loss, click here to participate.

We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at www.schallfirm.com, or by email at [email protected].

The class, in this case, has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member.

According to the Complaint, the Company made false and misleading statements to the market. MoonLake misled the market about its drug candidate, sonelokimab (SLK), which it claimed was superior to other monoclonal antibodies. The Company consistently touted its superiority while knowing it had no proven advantages over other treatments. The Company announced the results of a Phase 3 trial of SLK, disclosing what analysts labeled a "disastrous result," leading to its shares losing almost 90% of their value. Based on these facts, the Company's public statements were false and materially misleading throughout the class period. When the market learned the truth about MoonLake, investors suffered damages.

Join the case to recover your losses

The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.          

CONTACT:

The Schall Law Firm
Brian Schall, Esq.,
www.schallfirm.com
Office: 310-301-3335
[email protected]

SOURCE The Schall Law Firm

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October 20, 2025 02:00 ET

 | Source:

VAALCO Energy, Inc.

HOUSTON, Oct. 20, 2025 (GLOBE NEWSWIRE) -- VAALCO Energy, Inc. (NYSE: EGY; LSE: EGY) (“Vaalco” or the “Company”) today announced the timing of its third quarter 2025 earnings release and conference call.

The Company will issue its third quarter 2025 earnings release on Monday, November 10, 2025 after the close of trading on the New York Stock Exchange and host a conference call to discuss its financial and operational results on Tuesday morning, November 11, 2025 at 9:00 a.m. Central Time (10:00 a.m. Eastern Time and 3:00 p.m. London Time.)

Interested parties in the United States may participate toll-free by dialing (833) 685-0907. Interested parties in the United Kingdom may participate toll-free by dialing 08082389064. Other international parties may dial (412) 317-5741. Participants should ask to be joined to the “Vaalco Energy Earnings Conference Call.” This call will also be webcast on VAALCO’s website at www.vaalco.com. An audio replay will be available on the Company’s website following the call.

About Vaalco

Vaalco, founded in 1985 and incorporated under the laws of Delaware, is a Houston, Texas, USA based, independent energy company with a diverse portfolio of production, development and exploration assets across Gabon, Egypt, Côte d’Ivoire, Equatorial Guinea, Nigeria and Canada.

For Further Information   Vaalco Energy, Inc. (General and Investor Enquiries)+00 1 713 543 3422Website:www.vaalco.com  Al Petrie Advisors (US Investor Relations)+00 1 713 543 3422Al Petrie / Chris Delange   Buchanan (UK Financial PR)+44 (0) 207 466 5000Ben Romney / Barry [email protected]  

, /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, reminds investors of a class action lawsuit against Quanex Building Products Corporation ("Quanex" or "the Company") (NYSE: NX) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.

Investors who purchased the Company's securities between December 12, 2024 and September 5, 2025, inclusive (the "Class Period"), are encouraged to contact the firm before November 18, 2025.

If you are a shareholder who suffered a loss, click here to participate.

We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at www.schallfirm.com, or by email at [email protected].

The class, in this case, has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member.

According to the Complaint, the Company made false and misleading statements to the market. Quanex "underinvested" in tooling and equipment maintenance for its Tyman Mexico facility. The Company's tooling and equipment had degraded to "catastrophic" levels due to its poor maintenance practices. The Company was likely to incur significant expenses to repair equipment, delaying the benefit of its Tyman integration. The Company was aware of these issues before they became serious. Based on these facts, the Company's public statements were false and materially misleading throughout the class period. When the market learned the truth about Quanex, investors suffered damages.

Join the case to recover your losses

The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.          

CONTACT:

The Schall Law Firm
Brian Schall, Esq.,
www.schallfirm.com
Office: 310-301-3335
[email protected]

SOURCE The Schall Law Firm

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CALGARY, AB / ACCESS Newswire / October 20, 2025 / Tocvan Ventures Corp. ("Tocvan" or the "Company") (CSE:TOC)(OTCQB:TCVNF)(WKN:TV3/A2PE64), is pleased to announce the mobilization of equipment to both the North and South Blocks of its flagship Gran Pilar Gold-Silver Project in Sonora, Mexico. This marks a significant step forward in preparing the site for upcoming drilling, trenching activities, and ground preparation for the planned pilot mine operation.

, /PRNewswire/ -- HD Hyundai announced that Executive Vice Chairman Chung Kisun has been promoted to Chairman in its latest executive appointments.

Chung Kisun, HD Hyundai Chairman

Chairman Chung holds a bachelor's degree in Economics from Yonsei University and an MBA from Stanford University in the United States. He began his career in 2009 in the Finance Team of the Corporate Planning Division at HD Hyundai Heavy Industries. Since then, he has served as Head of Management Support at HD Hyundai, Head of Ship Sales at HD Hyundai Heavy Industries, and CEO of HD Hyundai Marine Solution. He currently serves as CEO of HD Hyundai, the holding company, as well as HD Korea Shipbuilding & Offshore Engineering, the intermediate holding company for the shipbuilding division. In this latest personnel announcement, Chairman Chung was also appointed Co-CEO of HD Hyundai XiteSolution, where he will lead efforts to overcome the recent downturn in the construction equipment business and establish new growth drivers.

Chairman Chung spearheaded the establishment of HD Hyundai Marine Solution in 2016, developing it into one of the group's core businesses with a market capitalization of KRW 11 trillion. In 2021, he led the acquisition of Doosan Infracore, nurturing the construction equipment business into another key growth pillar for the group. As Executive Vice Chairman, he directly oversaw major strategic issues across the HD Hyundai Group. More recently, he has focused on securing the company's future growth engines — including artificial intelligence (AI), digital innovation, and eco-friendly core technologies — while strengthening cooperation with the United States, which has renewed its commitment to revitalizing the shipbuilding industry, by engaging with key U.S. figures.

An HD Hyundai official stated, "This appointment reflects our determination to pioneer a new era under strong leadership amid an increasingly competitive and diversified global business environment," adding "By maintaining our leadership in the shipbuilding industry, HD Hyundai will contribute to the success of the Korea–U.S. Shipbuilding Cooperation Project, as well as to the growth of the Korean economy and the advancement of national interests."

SOURCE HD Hyundai

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, /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, reminds investors of a class action lawsuit against Fly-E Group, Inc. ("Fly-E" or "the Company") (NASDAQ: FLYE) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.

Investors who purchased the Company's securities between July 15, 2025, and August 14, 2025, inclusive (the "Class Period"), are encouraged to contact the firm before November 7, 2025.

If you are a shareholder who suffered a loss, click here to participate.

We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at www.schallfirm.com, or by email at [email protected].

The class, in this case, has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member.

According to the Complaint, the Company made false and misleading statements to the market. Fly-E shared optimistic revenue goals with investors only for its actual performance to fall far short of its projections. The Company overstated its brand reputation, cost reductions, and ability to secure favorable pricing from suppliers. The Company failed to successfully grow its sales network. Based on these facts, the Company's public statements were false and materially misleading throughout the class period. When the market learned the truth about Fly-E, investors suffered damages.

Join the case to recover your losses

The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.          

CONTACT:

The Schall Law Firm
Brian Schall, Esq.,
www.schallfirm.com
Office: 310-301-3335
[email protected]

SOURCE The Schall Law Firm

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– Zanzalintinib in combination with atezolizumab improved median overall survival to 10.9 months versus 9.4 months with regorafenib, and significantly reduced the risk of death by 20% in the intention-to-treat population –

– Exelixis plans to complete its first new drug application submission for zanzalintinib in the U.S. in 2025 –

ALAMEDA, Calif.--(BUSINESS WIRE)--Exelixis, Inc. (Nasdaq: EXEL) today announced detailed results from STELLAR-303, a global phase 3 pivotal trial evaluating zanzalintinib in combination with atezolizumab (Tecentriq®) versus regorafenib in patients with previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer (CRC). As previously announced, the study met one of its dual primary endpoints, demonstrating a 20% reduction in the risk of death with the combination in the intention-to-treat (ITT) population at the final analysis (stratified hazard ratio [HR]: 0.80; 95% confidence interval [CI]: 0.69-0.93; P=0.0045). At a median follow-up of 18.0 months, median overall survival (OS) in the ITT population was 10.9 months with zanzalintinib in combination with atezolizumab versus 9.4 months with regorafenib. Detailed findings from the study, including OS and progression-free survival (PFS) in the ITT population and in the subset of patients without liver metastases, are being presented today at the 2025 European Society for Medical Oncology (ESMO) Congress during the Proffered Paper Session 2: GI Tumours, Lower Digestive at 9:25 a.m. CEST and simultaneously published in The Lancet.

“While treating non-MSI-high metastatic colorectal cancer remains a challenge, the combination of zanzalintinib and atezolizumab has shown consistent benefits across key subgroups of patients,” said Anwaar Saeed, M.D., Section Chief of Gastrointestinal Oncology at the University of Pittsburgh, Director of the Gastrointestinal Disease Center at UPMC Hillman Cancer Center and a lead investigator of the trial. “STELLAR-303 is the first immunotherapy-based phase 3 trial that demonstrated improved overall survival with a differentiated kinase inhibitor compared to a standard of care in this patient population. The survival benefit was demonstrated early and was consistent throughout the trial, underscoring the combination’s potential for patients in need of a new and effective treatment option after disease progression.”

An OS benefit with the combination was consistently observed across pre-specified subgroups, including geographic region, RAS status, liver involvement and prior anti-VEGF therapy, as presented in Table 1 below. The 12- and 24-month landmark OS estimates were 46% (95% CI: 41-51) and 20% (95% CI: 15-26), respectively, for the combination of zanzalintinib and atezolizumab, and 38% (95% CI: 34-43) and 10% (95% CI: 6-16), respectively, for regorafenib.

TABLE 1

Median OS, months (95% CI)

HR (95% CI)

Zanzalintinib + Atezolizumab

Regorafenib

Geographic region

Asia

11.5 (9.2-13.7)

8.8 (7.8-10.4)

0.77 (0.59-1.00)

Rest of the world

10.9 (9.3-12.3)

9.8 (8.3-10.9)

0.82 (0.68-0.99)

RAS status

Wild type

12.0 (10.1-14.6)

10.4 (8.7-12.3)

0.79 (0.61-1.01)

Mutant

10.3 (9.0-11.9)

8.7 (8.1-9.8)

0.80 (0.66-0.98)

Active liver metastases

Presence

8.9 (8.0-9.9)

7.7 (6.5-8.5)

0.78 (0.65-0.94)

Absence

15.9 (13.5-17.6)

12.8 (10.9-15.5)

0.77 (0.59-1.01)

Prior anti-VEGF antibody treatment

Yes

10.6 (9.3-12.5)

8.8 (8.3-9.9)

0.80 (0.68-0.95)

No

11.5 (8.7-13.5)

11.1 (9.5-12.6)

0.80 (0.56-1.15)

OS = overall survival; CI = confidence interval; HR = hazard ratio; VEGF = vascular endothelial growth factor

Data pertaining to the other dual primary endpoint, OS in patients without liver metastases (non-liver metastases, NLM), were immature at the data cutoff. A prespecified interim analysis showed a trend in OS favoring the combination (15.9 months versus 12.8 months; stratified HR: 0.79; 95% CI: 0.61-1.03; P=0.0875) at a median follow-up of 16.8 months. The trial will proceed to the planned final analysis for this endpoint.

“These detailed results from STELLAR-303 provide further insight into the combination of zanzalintinib and atezolizumab as a potential new option to extend survival in patients with previously treated metastatic colorectal cancer,” said Dana T. Aftab, Ph.D., Executive Vice President, Research and Development, Exelixis. “Before the end of this year, we intend to complete the submission of our first new drug application for zanzalintinib as we work toward bringing this combination regimen to a patient community seeking a new and chemotherapy-free option. These data, along with our robust clinical trial program, underscore the progress we are making toward our goal of increasing the scope and scale of the solid tumor types zanzalintinib may help address.”

A trend for improvement in PFS with the combination was also observed in the ITT population (stratified HR: 0.68 [95% CI: 0.59–0.79]; median, 3.7 [95% CI: 3.5–3.8] months versus 2.0 [95% CI: 1.9–2.6] months), though statistical superiority cannot be claimed at this time due to the prespecified hierarchical testing strategy. The trend for PFS improvement with zanzalintinib in combination with atezolizumab versus regorafenib was consistent across subgroups.

The safety profiles of zanzalintinib in combination with atezolizumab and of regorafenib were generally consistent with what has been previously observed, and no new safety signals were identified. Grade 3/4 treatment-related adverse events (AEs) occurred in 59% of patients receiving zanzalintinib in combination with atezolizumab and 37% of patients receiving regorafenib. AEs leading to discontinuation of all study treatment occurred in 18% versus 15% of patients, respectively. The most common grade 3/4 treatment-related AEs were hypertension (15% versus 9%, respectively), fatigue (6% versus 2%), diarrhea (6% versus 2%) and proteinuria (6% versus 2%). Deaths considered related to treatment by investigators were two for zanzalintinib, two for atezolizumab, one for the combination and one for regorafenib.

About STELLAR-303

STELLAR-303 (NCT05425940) is a global, multicenter, randomized, phase 3, open-label study that randomized patients 1:1 to either zanzalintinib in combination with atezolizumab (n=451) or regorafenib (n=450). The study includes patients with previously treated non-MSI-high metastatic CRC. The dual primary endpoints of the study are OS in the ITT population and in the NLM subgroup of patients. The ITT population consisted of all randomized patients, regardless of the presence of liver metastases. The NLM subgroup consisted of patients who did not have active liver metastases at baseline as determined by investigator assessment. Secondary endpoints include PFS, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. More information about the trial is available at ClinicalTrials.gov.

About Zanzalintinib

Zanzalintinib is a novel oral kinase inhibitor that inhibits the activity of the TAM kinases (TYRO3, AXL, MER), MET and VEGF receptors. These kinases play important roles in oncogenic processes including tumor cell proliferation, metastasis, angiogenesis, drug resistance and evasion of antitumor immunity. With zanzalintinib, Exelixis sought to build upon its extensive experience with the target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. Zanzalintinib is currently being developed for the treatment of advanced solid tumors, including colorectal cancer, kidney cancer and neuroendocrine tumors.

Zanzalintinib is an investigational agent that is not approved for any use and is the subject of ongoing clinical trials.

About CRC

CRC is the third most common cancer and the second leading cause of cancer-related deaths in the U.S.1 Approximately 154,000 new cases will be diagnosed in the U.S. with around 53,000 expected deaths from the disease in 2025.1 CRC is most frequently diagnosed among people aged 65-74 and is more common in men and in people of non-Hispanic American Indian/Alaska Native descent.2 Nearly a quarter of CRC cases are diagnosed at the metastatic stage, at which point the five-year survival rate is just 16.2%.2 The liver is the most common site for CRC metastasis. Liver metastases significantly impact survival, with a median five-year survival rate of less than 14% when treated with palliative chemotherapy.3

About Exelixis

Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules and biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to: the presentation of detailed results from the STELLAR-303 pivotal trial at ESMO 2025; the therapeutic potential of zanzalintinib in combination with atezolizumab to become a new and effective treatment option to extend survival for patients with previously treated metastatic CRC; Exelixis’ plans to complete a new drug application submission for zanzalintinib in the U.S. in 2025; Exelixis’ progress in clinical trials towards the goal of increasing the scope and scale of solid tumor types zanzalintinib may address; and Exelixis’ scientific pursuit to create transformational treatments that give more patients hope for the future. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the availability of data at the referenced times; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis’ continuing compliance with applicable legal and regulatory requirements; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating zanzalintinib; Exelixis’ dependence on third-party vendors for the development, manufacture and supply of zanzalintinib; Exelixis’ ability to protect its intellectual property rights; market competition; changes in economic and business conditions; and other factors affecting Exelixis and its development programs detailed from time to time under the caption “Risk Factors” in Exelixis’ most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis’ future filings with the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

Exelixis, the Exelixis logo and CABOMETYX are registered U.S. trademarks of Exelixis.

TECENTRIQ is a registered U.S. trademark of Genentech, a member of the Roche Group.

More News From Exelixis, Inc.

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ESMO: AlphaMedixTM phase 2 data support first-in-class potential of new targeted alpha therapy in gastroenteropancreatic neuroendocrine tumors

New AlphaMedix data showed sustained and clinically meaningful responses across both RLT-naïve and RLT-exposed patients with unresectable or metastatic GEP-NETs First phase 2 study to evaluate TAT with lead-212 supporting its potential to address high unmet medical needs in difficult-to-treat, rare cancersPhase 2 study met all primary efficacy endpoints and was presented across two oral presentations at the 2025 ESMO Congress in Berlin, Germany Paris, October 20, 2025. New data from the ALPHAMEDIX-02 phase 2 study (clinical study identifier: NCT05153772) evaluating AlphaMedix (212Pb-DOTAMTATE), an investigational somatostatin receptor (SSTR) targeted alpha therapy (TAT) using the lead-212 isotope, underscore the first-in-class potential of this investigational medicine for the treatment of patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Detailed results from the phase 2 study, the first to evaluate a TAT across both radioligand therapy (RLT)-naïve and RLT-exposed patients affected by GEP-NETs, were presented in two oral presentations at the 2025 European Society for Medical Oncology (ESMO) Congress, Berlin, Germany.

“Lead-212-based Targeted Alpha Therapy (TAT) could have a transformative impact across a broad range of solid tumors. With AlphaMedix’s consistent and clinically meaningful responses across both RLT-naïve and RLT-exposed gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients, the positive results underscore its potential in this rare and difficult-to-treat cancer,” said Volker Wagner, MD, PhD, Chief Medical Officer at Orano Med. “These data strongly encourage us to further advance the clinical development of AlphaMedix, and jointly with our partner, Sanofi, make this innovative TAT available to patients in need.”

ALPHAMEDIX-02 phase 2 study
ALPHAMEDIX-02 is a phase 2, open-label, multicenter study evaluating the efficacy and safety of AlphaMedix in patients with unresectable or metastatic SSTR+ GEP-NETs. The study included two cohorts evaluating RLT-naïve and RLT-exposed patients. The primary efficacy endpoint across both cohorts was the overall response rate (ORR). Secondary endpoints included progression-free survival (PFS) and overall survival (OS).

The study's efficacy endpoints are based on local investigator assessment, per protocol. In addition, a blinded independent central review (BICR) was conducted subsequently. The key efficacy endpoints were met within both the investigator-assessed and BICR results.

The following results were presented:

RLT-Naïve
(n=35)
  Investigator assessment Independent assessment (BICR) *DOR is determined only for participants who have achieved a confirmed complete response (CR) or partial response (PR) per RECIST 1.1
**Defined as the percentage of patients achieving CR or PR or SD per RECIST 1.1
***OS assessment is independent of RECIST 1.1 criteria, so BICR is n/a ORR 60.0%
(95% CI: 42.1-76.1) 57.1%
(95% CI: 39.4-73.7) Duration of Response (DoR) per Kaplan-Meier (KM) estimate (95% CI)* 71.9% for ≥ 24 months
(95% CI: 44.6-87.4) 81.7% for ≥ 24 months
(95% CI: 53.1-93.8) Complete Response (CR) - 2.9% Partial Response (PR) 60.0% 54.3% Stable Disease (SD) 34.3% 28.6% Disease control rate (DCR)** 94.3%
(95% CI: 80.8-99.3) 85.7%
(95% CI: 69.7-95.2) PFS 36-month PFS rate of 72.3%
(95% CI: 53.3-84.5) 36-month PFS rate of 63.3%
(95% CI: 40.3-79.4) OS 36-month OS rate of 88.2%
(95% CI: 71.5-95.4) Not applicable*** RLT-Exposed
(n=26)
  Investigator assessment Independent assessment (BICR) *DOR is determined only for participants who have achieved a confirmed complete response (CR) or partial response (PR) per RECIST 1.1
**Defined as the percentage of patients achieving CR or PR or SD per RECIST 1.1
***OS assessment is independent of RECIST 1.1 criteria, so BICR is n/a ORR 34.6%
(95% CI: 17.2-55.7) 19.2%
(95% CI: 6.6-39.4) Duration of Response (DoR) per Kaplan-Meier (KM) estimate (95% CI)* 100% for ≥ 18 months
(95% CI: 100-100) 100% for ≥ 18 months
(95% CI: 100-100) Partial Response (PR) 34.6% 19.2% Stable Disease (SD) 61.5% 80.8% Disease control rate (DCR)** 96.2%
(95% CI: 80.4-99.9) 100%
(95% CI: 86.8-100) PFS 18-month PFS rate of 82.6%
(95% CI: 59.0-93.3) 18-month PFS rate of 88%
(95% CI: 67.3-96.0) OS 18-month OS rate of 85.1%
(95% CI: 58.5-95.2) Not applicable*** AlphaMedix™ had a similar safety profile across both cohorts. Within the RLT-naïve cohort, 85.7% of patients received all four doses of AlphaMedix, and 84.6% of patients within the RLT-exposed cohort. All GEP-NET patients experienced at least one treatment-emergent adverse event (TEAE). Grade ≥3 TEAEs occurred in 42.3% of RLT-exposed patients and 54.3% of RLT-naïve patients. The most common Grade ≥3 TEAEs in both groups was lymphocyte count decrease (25.7% of RLT-naïve patients and 15.4% of RLT-exposed patients).

“The future of oncology research will be driven by cutting-edge science and next-generation modalities, such as radioligand therapies. AlphaMedix, a promising targeted alpha therapy, embodies the type of solution Sanofi is working to advance,” said Christopher Corsico, MD, Global Head of Development at Sanofi. “We are excited to share these robust scientific findings at ESMO as the data could represent a significant advancement in how we treat gastroenteropancreatic neuroendocrine tumors. As we engage with health authorities and advance the clinical program, we remain focused on bringing this innovative modality to patients who need new treatment options”

Advancing AlphaMedix in GEP-NETs
RLTs, which work by delivering radiation directly to tumor cells, represent an emerging area of oncology research. While current approved beta-emitting RLTs have improved outcomes in patients with GEP-NETs, there remains a critical gap in care, including in those who have progressed following previous RLT.

TAT represents an innovative modality in RLT, harnessing high-energy, short-range alpha emissions to precisely target cancer cells while reducing potential exposure to surrounding tissue.

"The results observed in the ALPHAMEDIX-02 trial clearly demonstrate exceptional levels of efficacy for a Targeted Alpha Therapy (TAT), based on current available therapies, in both radioligand therapy (RLT)-naïve and RLT-exposed populations and could potentially set new expectations when treating gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients with RLTs” said Ebrahim Delpassand, MD, Founder and Chairman, CEO of RadioMedix. “For too long, this patient population has experienced inadequate disease control with current approved therapies. This important work provides hope for a new treatment for GEP-NET patients, their caregivers, and their healthcare providers.”

In February 2024, AlphaMedix™ was designated as a breakthrough therapy by the US Food and Drug Administration in RLT-naïve patients with unresectable or metastatic GEP-NETs, recognizing the potential clinical benefits of lead-212–based TATs. The ALPHAMEDIX-02 results will form the basis for further discussions with health authorities.

An international phase 3 study to further evaluate AlphaMedix in GEP-NETs is actively being planned. AlphaMedix is an investigational medicine and has not been approved by any regulatory authority.

In September 2024, Sanofi entered an exclusive licensing agreement with Orano Med and RadioMedix to globally commercialize AlphaMedix.

About the ALPHAMEDIX-02 study
ALPHAMEDIX-02 is a phase 2, open-label, multicenter study evaluating the efficacy and safety of AlphaMedix (212Pb-DOTAMTATE) in patients with histologically confirmed unresectable or metastatic GEP-NETs, positive somatostatin analogue imaging and at least one site of measurable disease. The study included two cohorts evaluating RLT-naïve (n=35) and RLT-exposed (n=26) GEP-NET patients. RLT-exposed patients had progressive disease after receiving up to four doses of 177Lu-DOTATATE and received their last dose at least six months prior to Day 1. In both cohorts, AlphaMedix was administered at 67.6 μCi/kg every eight weeks for up to four cycles (6 mCi maximum per cycle). The primary efficacy endpoint across both cohorts was ORR per RECIST 1.1. Secondary endpoints included PFS and OS.

About NETs
NETs are a heterogeneous group of cancers that originate from neuroendocrine cells. These cancers occur mostly in the gastrointestinal tract and pancreas but can also occur in other tissues including the thymus, lung, and other uncommon sites such as the ovaries, heart, and prostate. Most NETs strongly express somatostatin receptors. Despite the global prevalence of NETs increasing each year, it is considered a rare cancer that is estimated to affect approximately 35/100,000 individuals worldwide. In the United States, around 12,000 patients annually are expected to be diagnosed with neuroendocrine tumors, with an average five-year survival rate of 60% at a metastatic stage.

About Orano Med
Orano Med is a subsidiary of the Orano Group. Orano Med is a clinical-stage biotechnology company that develops a new generation of targeted therapies against cancer using the unique properties of lead-212 (212Pb), an alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha Therapy (TAT). Leveraging its unique and secured access to 212Pb, the company is developing several 212Pb-based radioligand therapies combined with various targeting agents. Orano Med has 212Pb manufacturing facilities, laboratories, and R&D centers in France and in the US and is currently expanding its GMP-manufacturing capacities for 212Pb radiolabeled pharmaceuticals in North America and Europe.

About RadioMedix
RadioMedix, Inc., a clinical-stage biotechnology company and former sponsor of the AlphaMedix trial, is based in Houston and Humble, Texas. The company is focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. RadioMedix is developing radiopharmaceuticals for PET imaging and therapy (alpha- and beta-labeled agents). The company established contract service facilities for academic and industrial partners. including a cGMP and analytical suite for Phase I-II-III clinical trials and commercial launch. To learn more, visit www.radiomedix.com and LinkedIn.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | [email protected]
Evan Berland | +1 215 432 0234 | [email protected]  
Léo Le Bourhis | +33 6 75 06 43 81 | [email protected]  
Victor Rouault | +33 6 70 93 71 40 | [email protected]
Timothy Gilbert | +1 516 521 2929 | [email protected]
Léa Ubaldi | +33 6 30 19 66 46 | [email protected]

Investor Relations
Thomas Kudsk Larsen | +44 7545 513 693 | [email protected]  
Alizé Kaisserian | +33 6 47 04 12 11 | [email protected]
Felix Lauscher | +1 908 612 7239 | [email protected]  
Keita Browne | +1 781 249 1766 | [email protected]
Nathalie Pham | +33 7 85 93 30 17 | [email protected]
Tarik Elgoutni | +1 617 710 3587 | [email protected]  
Thibaud Châtelet | +33 6 80 80 89 90 | [email protected]
Yun Li | +33 6 84 00 90 72 | [email protected]

Orano Med
Regina Jehle | +33 6 74 56 11 31 | [email protected]
Orano Press Office | +33 (0)1 34 96 12 15| [email protected]

Sanofi forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

All trademarks mentioned in this press release are the property of the Sanofi group with the exception of Orano Med and AlphaMedix™.

Press_Release

ESMO: AlphaMedixTM phase 2 data support first-in-class potential of new targeted alpha therapy in gastroenteropancreatic neuroendocrine tumors

New AlphaMedix data showed sustained and clinically meaningful responses across both RLT-naïve and RLT-exposed patients with unresectable or metastatic GEP-NETs First phase 2 study to evaluate TAT with lead-212 supporting its potential to address high unmet medical needs in difficult-to-treat, rare cancersPhase 2 study met all primary efficacy endpoints and was presented across two oral presentations at the 2025 ESMO Congress in Berlin, Germany Paris, October 20, 2025. New data from the ALPHAMEDIX-02 phase 2 study (clinical study identifier: NCT05153772) evaluating AlphaMedix (212Pb-DOTAMTATE), an investigational somatostatin receptor (SSTR) targeted alpha therapy (TAT) using the lead-212 isotope, underscore the first-in-class potential of this investigational medicine for the treatment of patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Detailed results from the phase 2 study, the first to evaluate a TAT across both radioligand therapy (RLT)-naïve and RLT-exposed patients affected by GEP-NETs, were presented in two oral presentations at the 2025 European Society for Medical Oncology (ESMO) Congress, Berlin, Germany.

“Lead-212-based Targeted Alpha Therapy (TAT) could have a transformative impact across a broad range of solid tumors. With AlphaMedix’s consistent and clinically meaningful responses across both RLT-naïve and RLT-exposed gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients, the positive results underscore its potential in this rare and difficult-to-treat cancer,” said Volker Wagner, MD, PhD, Chief Medical Officer at Orano Med. “These data strongly encourage us to further advance the clinical development of AlphaMedix, and jointly with our partner, Sanofi, make this innovative TAT available to patients in need.”

ALPHAMEDIX-02 phase 2 study
ALPHAMEDIX-02 is a phase 2, open-label, multicenter study evaluating the efficacy and safety of AlphaMedix in patients with unresectable or metastatic SSTR+ GEP-NETs. The study included two cohorts evaluating RLT-naïve and RLT-exposed patients. The primary efficacy endpoint across both cohorts was the overall response rate (ORR). Secondary endpoints included progression-free survival (PFS) and overall survival (OS).

The study's efficacy endpoints are based on local investigator assessment, per protocol. In addition, a blinded independent central review (BICR) was conducted subsequently. The key efficacy endpoints were met within both the investigator-assessed and BICR results.

The following results were presented:

RLT-Naïve
(n=35)   Investigator assessment Independent assessment (BICR) *DOR is determined only for participants who have achieved a confirmed complete response (CR) or partial response (PR) per RECIST 1.1
**Defined as the percentage of patients achieving CR or PR or SD per RECIST 1.1
***OS assessment is independent of RECIST 1.1 criteria, so BICR is n/a ORR 60.0%
(95% CI: 42.1-76.1) 57.1%
(95% CI: 39.4-73.7) Duration of Response (DoR) per Kaplan-Meier (KM) estimate (95% CI)* 71.9% for ≥ 24 months
(95% CI: 44.6-87.4) 81.7% for ≥ 24 months
(95% CI: 53.1-93.8) Complete Response (CR) - 2.9% Partial Response (PR) 60.0% 54.3% Stable Disease (SD) 34.3% 28.6% Disease control rate (DCR)** 94.3%
(95% CI: 80.8-99.3) 85.7%
(95% CI: 69.7-95.2) PFS 36-month PFS rate of 72.3%
(95% CI: 53.3-84.5) 36-month PFS rate of 63.3%
(95% CI: 40.3-79.4) OS 36-month OS rate of 88.2%
(95% CI: 71.5-95.4) Not applicable*** RLT-Exposed
(n=26)   Investigator assessment Independent assessment (BICR) *DOR is determined only for participants who have achieved a confirmed complete response (CR) or partial response (PR) per RECIST 1.1
**Defined as the percentage of patients achieving CR or PR or SD per RECIST 1.1
***OS assessment is independent of RECIST 1.1 criteria, so BICR is n/a ORR 34.6%
(95% CI: 17.2-55.7) 19.2%
(95% CI: 6.6-39.4) Duration of Response (DoR) per Kaplan-Meier (KM) estimate (95% CI)* 100% for ≥ 18 months
(95% CI: 100-100) 100% for ≥ 18 months
(95% CI: 100-100) Partial Response (PR) 34.6% 19.2% Stable Disease (SD) 61.5% 80.8% Disease control rate (DCR)** 96.2%
(95% CI: 80.4-99.9) 100%
(95% CI: 86.8-100) PFS 18-month PFS rate of 82.6%
(95% CI: 59.0-93.3) 18-month PFS rate of 88%
(95% CI: 67.3-96.0) OS 18-month OS rate of 85.1%
(95% CI: 58.5-95.2) Not applicable*** AlphaMedix™ had a similar safety profile across both cohorts. Within the RLT-naïve cohort, 85.7% of patients received all four doses of AlphaMedix, and 84.6% of patients within the RLT-exposed cohort. All GEP-NET patients experienced at least one treatment-emergent adverse event (TEAE). Grade ≥3 TEAEs occurred in 42.3% of RLT-exposed patients and 54.3% of RLT-naïve patients. The most common Grade ≥3 TEAEs in both groups was lymphocyte count decrease (25.7% of RLT-naïve patients and 15.4% of RLT-exposed patients).

“The future of oncology research will be driven by cutting-edge science and next-generation modalities, such as radioligand therapies. AlphaMedix, a promising targeted alpha therapy, embodies the type of solution Sanofi is working to advance,” said Christopher Corsico, MD, Global Head of Development at Sanofi. “We are excited to share these robust scientific findings at ESMO as the data could represent a significant advancement in how we treat gastroenteropancreatic neuroendocrine tumors. As we engage with health authorities and advance the clinical program, we remain focused on bringing this innovative modality to patients who need new treatment options”

Advancing AlphaMedix in GEP-NETs
RLTs, which work by delivering radiation directly to tumor cells, represent an emerging area of oncology research. While current approved beta-emitting RLTs have improved outcomes in patients with GEP-NETs, there remains a critical gap in care, including in those who have progressed following previous RLT.

TAT represents an innovative modality in RLT, harnessing high-energy, short-range alpha emissions to precisely target cancer cells while reducing potential exposure to surrounding tissue.

"The results observed in the ALPHAMEDIX-02 trial clearly demonstrate exceptional levels of efficacy for a Targeted Alpha Therapy (TAT), based on current available therapies, in both radioligand therapy (RLT)-naïve and RLT-exposed populations and could potentially set new expectations when treating gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients with RLTs” said Ebrahim Delpassand, MD, Founder and Chairman, CEO of RadioMedix. “For too long, this patient population has experienced inadequate disease control with current approved therapies. This important work provides hope for a new treatment for GEP-NET patients, their caregivers, and their healthcare providers.”

In February 2024, AlphaMedix™ was designated as a breakthrough therapy by the US Food and Drug Administration in RLT-naïve patients with unresectable or metastatic GEP-NETs, recognizing the potential clinical benefits of lead-212–based TATs. The ALPHAMEDIX-02 results will form the basis for further discussions with health authorities.

An international phase 3 study to further evaluate AlphaMedix in GEP-NETs is actively being planned. AlphaMedix is an investigational medicine and has not been approved by any regulatory authority.

In September 2024, Sanofi entered an exclusive licensing agreement with Orano Med and RadioMedix to globally commercialize AlphaMedix.

About the ALPHAMEDIX-02 study
ALPHAMEDIX-02 is a phase 2, open-label, multicenter study evaluating the efficacy and safety of AlphaMedix (212Pb-DOTAMTATE) in patients with histologically confirmed unresectable or metastatic GEP-NETs, positive somatostatin analogue imaging and at least one site of measurable disease. The study included two cohorts evaluating RLT-naïve (n=35) and RLT-exposed (n=26) GEP-NET patients. RLT-exposed patients had progressive disease after receiving up to four doses of 177Lu-DOTATATE and received their last dose at least six months prior to Day 1. In both cohorts, AlphaMedix was administered at 67.6 μCi/kg every eight weeks for up to four cycles (6 mCi maximum per cycle). The primary efficacy endpoint across both cohorts was ORR per RECIST 1.1. Secondary endpoints included PFS and OS.

About NETs
NETs are a heterogeneous group of cancers that originate from neuroendocrine cells. These cancers occur mostly in the gastrointestinal tract and pancreas but can also occur in other tissues including the thymus, lung, and other uncommon sites such as the ovaries, heart, and prostate. Most NETs strongly express somatostatin receptors. Despite the global prevalence of NETs increasing each year, it is considered a rare cancer that is estimated to affect approximately 35/100,000 individuals worldwide. In the United States, around 12,000 patients annually are expected to be diagnosed with neuroendocrine tumors, with an average five-year survival rate of 60% at a metastatic stage.

About Orano Med
Orano Med is a subsidiary of the Orano Group. Orano Med is a clinical-stage biotechnology company that develops a new generation of targeted therapies against cancer using the unique properties of lead-212 (212Pb), an alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha Therapy (TAT). Leveraging its unique and secured access to 212Pb, the company is developing several 212Pb-based radioligand therapies combined with various targeting agents. Orano Med has 212Pb manufacturing facilities, laboratories, and R&D centers in France and in the US and is currently expanding its GMP-manufacturing capacities for 212Pb radiolabeled pharmaceuticals in North America and Europe.

About RadioMedix
RadioMedix, Inc., a clinical-stage biotechnology company and former sponsor of the AlphaMedix trial, is based in Houston and Humble, Texas. The company is focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. RadioMedix is developing radiopharmaceuticals for PET imaging and therapy (alpha- and beta-labeled agents). The company established contract service facilities for academic and industrial partners. including a cGMP and analytical suite for Phase I-II-III clinical trials and commercial launch. To learn more, visit www.radiomedix.com and LinkedIn.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | [email protected]
Evan Berland | +1 215 432 0234 | [email protected]  
Léo Le Bourhis | +33 6 75 06 43 81 | [email protected]  
Victor Rouault | +33 6 70 93 71 40 | [email protected]
Timothy Gilbert | +1 516 521 2929 | [email protected]
Léa Ubaldi | +33 6 30 19 66 46 | [email protected]

Investor Relations
Thomas Kudsk Larsen | +44 7545 513 693 | [email protected]  
Alizé Kaisserian | +33 6 47 04 12 11 | [email protected]
Felix Lauscher | +1 908 612 7239 | [email protected]  
Keita Browne | +1 781 249 1766 | [email protected]
Nathalie Pham | +33 7 85 93 30 17 | [email protected]
Tarik Elgoutni | +1 617 710 3587 | [email protected]  
Thibaud Châtelet | +33 6 80 80 89 90 | [email protected]
Yun Li | +33 6 84 00 90 72 | [email protected]

Orano Med
Regina Jehle | +33 6 74 56 11 31 | [email protected]
Orano Press Office | +33 (0)1 34 96 12 15| [email protected]

Sanofi forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

All trademarks mentioned in this press release are the property of the Sanofi group with the exception of Orano Med and AlphaMedix™.

Press_Release

About Jamie Ashcroft
Jamie Ashcroft, the News Editor for Proactive UK, has developed an impressive career in financial journalism, focusing on the small-cap sector for over fourteen years. Before joining the Proactive team, he was a stockbroker during the global financial crisis, a role that complemented his educational background - a first-class degree in Business and Economics and qualifications in software design and development.
As one of the early external hires at Proactive in 2009, Jamie contributed... Read more

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The Food and Drug Administration approved Gazyva for the treatment of adults receiving standard therapy for a form of lupus that targets the kidneys.

Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

SummaryJPIE invests in a diversified portfolio of bonds, focusing on high-quality MBS.JPIE maintains below-average risk and volatility due to its short duration and high credit quality, making it resilient in various market conditions.It has an above-average 5.8% dividend yield too, with strong, consistent returns in the past and very strong risk-adjusted returns.It is a fantastic, high-quality income ETF, perfect for more risk-averse investors.This idea was discussed in more depth with members of my private investing community, CEF/ETF Income Laboratory. Learn More »Pornyot Palilai/iStock via Getty Images

In keeping with my coverage of high-quality, diversified bond ETFs, I thought to have a second look at the JPMorgan Income ETF (NYSEARCA:JPIE). JPIE offers investors diversified exposure to bonds, with a focus on

Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

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Investment Thesis The Fidelity MSCI Consumer Staples Index ETF (NYSEARCA:FSTA) warrants a buy rating due to the profitable, stable revenue of its top holdings. Additionally, the consumer staples sector has historically performed well during times of declining

Analyst’s Disclosure:I/we have a beneficial long position in the shares of WMT, VDC either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

This article is exclusive to Seeking Alpha. No duplication or reproduction of this article is allowed without consent of Seeking Alpha and the author. This article should not be misconstrued as individual financial advice. Always conduct your own due diligence prior to investing.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

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SummaryiShares U.S. Home Construction ETF is rated a buy, with the recent pullback seen as a buying opportunity.Lower mortgage rates and the Fed's rate-cutting stance support a bullish outlook for ITB, despite recent volatility and cyclical risks.The fund remains attractively valued, with a forward P/E near 12x, and seasonality favors a potential year-end rally, especially in November.Technical analysis shows ITB bouncing off its 200-day moving average, with $99 as support and $118 as resistance amid mixed market sentiment. Yobro10/iStock via Getty Images

History reveals that there’s rarely a graceful and elegant rate-cutting cycle. The Fed began lowering its policy rate in September 2024, and at the time, it was for somewhat sanguine reasons. Yes, there was a modest growth scare in Q3

Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

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Businesses report AI momentum – but foundational gaps in tech and talent now define the next phase of progress

, /PRNewswire/ -- Kyndryl (NYSE: KD), a leading provider of mission-critical enterprise services, today released its second annual Kyndryl Readiness Report, drawing on responses from 3,700 senior leaders across 21 countries. The data reveals an instance of momentum and reflection – as businesses report growing returns from AI investments while facing mounting pressure to modernize infrastructure, scale innovation efforts, reskill workforces and manage risk in an increasingly fragmented regulatory landscape.

"A readiness gap exists as enterprises grapple with the promise of transformative value from AI," said Martin Schroeter, Chairman and CEO of Kyndryl. "While 90% of organizations think they have the tools and processes to scale innovation, more than half are stalled by their tech stack, and less than a third say their employees are truly ready for AI. Closing that gap is the challenge and opportunity ahead."

Last year's report revealed a critical gap between perception and preparedness: while 90% of business leaders believed their IT infrastructure was best in class, only 39% felt it was ready for future disruption. While there has been momentum – that tension remains. This year:

ROI on the rise, but AI stuck in experimentation phase: While 54% of organizations reported seeing positive returns on AI investments – an increase of 12 points from 2024 – 62% still haven't advanced their AI projects beyond the pilot stage.
Confidence continues to outweigh capability: While 90% say their tools and processes allow them to rapidly test and scale new ideas, more than half say their foundational technology stack holds back innovation.
AI driving workforce transformation, but skills gaps remain: 87% say AI will "completely" transform jobs at their organizations within 12 months, even though many say their employees are not using AI frequently today and few have the technical skills necessary.
Geopolitical pressures forcing a data pivot: While reporting clear benefits from cloud adoption, organizations are now reevaluating where and how their data is stored, processed, accessed and secured amid an increasingly fragmented regulatory landscape. Businesses are also balancing legacy infrastructure challenges, with 70% of CEOs saying they reached their cloud setup "by accident rather than design."

AI spending rises along with ROI expectations – with cyber resilience top of mind

Business leaders across all industries and countries say their company's AI spending jumped 33% on average since last year, with 68% investing "heavily" in at least one form of AI. As AI investments rise, so does the pressure to show value – and protect it. Three in five leaders say they feel more pressure this year to deliver ROI from AI than last. Their top use case? Cybersecurity.

Cloud is under pressure as geopolitical and regulatory disruption drive change

Many organizations are also revisiting their cloud infrastructure, prompted by new global regulations and growing concerns about data sovereignty. Three in four leaders report concerns about the geopolitical risks associated with storing and managing data in global cloud environments, and 65% have adjusted their cloud strategies in response – by investing in data repatriation, reassessing vendors, and shifting toward private cloud models.

Talent and Culture – the next readiness frontier

As leaders look to scale innovation, people readiness is emerging as a key barrier – and a key opportunity. While nearly 9 in 10 believe AI will completely reshape jobs in the next year, only 29% feel their workforce is ready to successfully leverage the technology and concerns remain around the skills needed to succeed in this era. Many organizations are also battling cultural barriers – with nearly half of CEOs reporting their organization stifles innovation (48%) and moves too slowly in decision-making (45%). Those pulling ahead – dubbed "Pacesetters" in the report – aren't just investing in innovation. They're uniquely prioritizing culture, upskilling and leadership alignment.

Compared to organizations who are lagging in these areas, Pacesetters are:

32 points less likely to cite their tech stack as a barrier
30 points more likely to say their cloud can adapt to new regulations
20 points less likely to report a cyber-related outage in the past year

To read the report, visit Kyndryl's Readiness Report.

Methodology

The 2025 Kyndryl Readiness Report combines survey data from 3,700 senior leaders and decision-makers across 21 countries with insights from Kyndryl Bridge, the company's AI-powered, open integration digital business platform. The Report uncovers the drivers, barriers and trade-offs that can make or break the ability of organizations to protect, sustain and accelerate their performance and future-proof their mission-critical processes.

About Kyndryl
Kyndryl (NYSE: KD) is a leading provider of mission-critical enterprise technology services, offering advisory, implementation and managed service capabilities to thousands of customers in more than 60 countries. As the world's largest IT infrastructure services provider, the company designs, builds, manages and modernizes the complex information systems that the world depends on every day. For more information, visit www.kyndryl.com.

Kyndryl press contact
[email protected]

SOURCE Kyndryl

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October 20, 2025 12:15 AM EDT | Source: Manganese X Energy Corp.
Montreal, Quebec--(Newsfile Corp. - October 20, 2025) - Manganese X Energy Corp. (TSXV: MN) (FSE: 9SC) (TRADEGATE: 9SC) (OTCQB: MNXXF) ("Manganese X" or the "Company") spokesperson, CEO Martin Kepman, stressed the urgency of establishing a North American battery materials supply chain due to China's recently imposed stringent export controls on critical minerals.

China's new export control regulations, taking effect November 8, 2025, impose export controls on high-performance lithium-ion batteries, cathode materials, including lithium iron phosphate (LFP), ternary precursors, and lithium-rich manganese-based materials, as well as graphite anode materials and key production technologies.

Kepman stated, "These measures represent a significant escalation in China's control over the export of critical materials essential to global EV, battery energy storage system (BESS) and defence industries. The restrictions are expected to disrupt international supply chains and accelerate the push for North American and European self-sufficiency in battery material production."

He added, "China's latest export controls underscore the urgency of establishing a secure and independent North American battery materials supply chain. Manganese X's Battery Hill manganese project, located in Woodstock, New Brunswick, Canada, is a vital step towards ensuring a domestic production of high-purity manganese (HPMSM) — a key ingredient in next-generation EV cathode chemistries such as lithium manganese-rich (LMR), lithium manganese iron phosphate (LMFP) and nickel manganese cobalt (NMC)."

Manganese X, with its Battery Hill manganese deposit, is strategically positioned to help fill this emerging supply gap. The Company's mission has long been to supply ethically sourced, high-quality manganese materials for the North American EV and energy storage markets, reducing dependency on foreign — particularly Chinese — processing capacity.

Manganese is an increasingly critical component in high-performance and cost-efficient EV batteries. The addition of manganese chemistries enhances energy density, stability, and range — properties now sought after by leading battery and automotive manufacturers worldwide.

"The geopolitical landscape for critical minerals is shifting rapidly," said Kepman. "Our goal is to position Manganese X as a cornerstone supplier of North American high purity manganese, fully aligned with government initiatives promoting energy security, economic resilience, and clean technology leadership."

As nations adjust to these new trade dynamics, Manganese X remains committed to supporting the growth of a sustainable, transparent, and regionally secure EV battery and back up energy ecosystem across North America.

About Manganese X Energy Corp.

Manganese X's mission is to advance its Battery Hill project into production, thereby becoming the first public actively traded manganese mining company in Canada and US to commercialize EV compliant high purity manganese, potentially supplying the North American supply chain. The Company intends on supplying value-added materials to the lithium-ion battery and other alternative energy industries, as well as striving to achieve new carbon-friendly more efficient methodologies, while processing manganese at a lower competitive cost.

For more information visit the Company's website at www.manganesexenergycorp.com.

On behalf of the Board of Directors of
MANGANESE X ENERGY CORP.

Martin Kepman
CEO and Director
Email: [email protected]
Tel: 1-514-802-1814

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Cautionary Note Regarding Forward-Looking Statements:

This news release contains certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable securities legislation. All statements, other than statements of historical fact, included herein, without limitation, statements relating to the future operations and activities of Manganese X, are forward-looking statements. Forward-looking statements in this news release relate to the effect of China's export controls, and the effective date thereof, on critical minerals, the supply chain of battery minerals and any disruption thereto, and the Company's goals and plans to support a North American battery materials supply chain through the development of its Battery Hill manganese deposit. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates that, while considered reasonable by Manganese X, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors, both known and unknown, could cause actual results, performance or achievements to be materially different from the results, performance or achievements that are or may be expressed or implied by such forward-looking statements and the parties have made assumptions and estimates based on or related to many of these factors. These risks, as well as others, are disclosed within the Company's filings on SEDAR+ (www.sedarplus.ca), which investors are encouraged to review prior to any transaction involving the securities of the Company. Readers should not place undue reliance on the forward-looking statements. Manganese X does not assume any obligation to update the forward-looking statements if beliefs, opinions, projections, or other factors, should change, except as required by applicable securities laws.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/271017

Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

– FDA approval based on superiority of Gazyva over standard therapy alone, as shown in Phase II NOBILITY and Phase III REGENCY data –

– Gazyva is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomized Phase III study –

– Lupus nephritis affects more than 1.7 million people worldwide, predominantly women of color and childbearing age, with up to one third of patients progressing to end-stage kidney disease –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Gazyva® (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients. Following four initial doses in the first year, Gazyva can be administered twice yearly, offering an effective and potentially more convenient treatment option than traditional targeted therapies.

“People with lupus nephritis who achieve a complete renal response are more likely to experience preserved kidney function and delay, or even prevention, of progression to end-stage kidney disease,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “The approval of Gazyva by the FDA marks an important step towards a potential new standard of care for lupus nephritis, one that could allow clinicians to offer their patients more effective disease control.”

“As a severe and potentially life-threatening disease, lupus nephritis greatly disrupts daily life with chronic pain, fatigue, and the constant fear of worsening kidney health,” said Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America. “The FDA’s approval of Gazyva offers renewed hope for people with lupus nephritis and their loved ones, as it provides an important new treatment option that has the potential to prevent long-term complications, including kidney failure.”

This approval is based on positive results from the Phase II NOBILITY and Phase III REGENCY studies. In REGENCY, data showed that nearly half of the participants (46.4%) on Gazyva in combination with standard therapy achieved a complete renal response (CRR) compared to 33.1% on standard therapy alone. This was accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, corticosteroid use, and proteinuria, all signaling improved disease control. The safety profile of Gazyva was consistent with the well-characterized profile observed in its hematology-oncology indications.

Lupus nephritis affects more than 1.7 million people worldwide. It disproportionately impacts women, mostly women of color and of childbearing age, who often face more severe disease. If left untreated, up to one-third of individuals can progress to end-stage kidney disease, which often requires dialysis or transplantation.

Gazyva was granted Breakthrough Therapy Designation by the FDA in 2019 based on data from the Phase II NOBILITY study. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recently issued a positive opinion recommending the approval of Gazyva for adults with active lupus nephritis, with a final decision from the European Commission expected in the near future.

Gazyva is being investigated in people with systemic lupus erythematosus, membranous nephropathy, idiopathic nephrotic syndrome, and in children and adolescents with lupus nephritis. In addition to Gazyva, Genentech has a broad pipeline targeting the immune drivers of rare and common kidney and kidney-related diseases.

About Gazyva

Gazyva® (obinutuzumab) is a Type II engineered humanized monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells. In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys and reduces their ability to function properly. Data suggests that Gazyva depletes disease-causing B cells, helping to limit further damage to the kidneys and potentially preventing or delaying progression to end-stage kidney disease.

Gazyva is already approved in 100 countries for various types of hematological cancers. In the United States, Gazyva is part of a collaboration between Genentech and Biogen.

About the REGENCY Study

REGENCY [NCT04221477] is a Phase III, randomized, double-blind, placebo-controlled, multicenter study investigating the efficacy and safety of Gazyva® (obinutuzumab) plus standard therapy (mycophenolate mofetil and glucocorticoids) in people with active/chronic International Society of Nephrology/Renal Pathology Society 2003 proliferative Class III or IV lupus nephritis, with or without Class V. The study enrolled 271 people, who were randomized 1:1 to receive either Gazyva plus standard therapy or placebo plus standard therapy. REGENCY was designed based on robust Phase II data and conducted during the COVID-19 pandemic. The study population was representative of the real-world population of people with lupus nephritis.

About Lupus Nephritis

Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus (SLE), an autoimmune disease that commonly affects the kidneys. Lupus nephritis is characterized by an irreversible loss of nephrons, the filtering structures of the kidneys. Periods of intense disease activity, known as flares, can speed up the loss of nephrons and be left unchecked, leading to a progressive loss of kidney function. Even with the latest treatments, up to a third of people will progress to end-stage kidney disease, where dialysis or transplant are the only options and life expectancy and quality of life are substantially reduced.

Lupus nephritis affects more than 1.7 million people worldwide - predominantly women, mostly of color and usually of childbearing age. Currently, there is no cure.

Indication

GAZYVA® (obinutuzumab) is indicated for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy

Important Safety Information

The most important safety information patients should know about GAZYVA

Patients must tell their doctor right away about any side effect they experience. GAZYVA can cause side effects that can become serious or life-threatening, including:

Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If the patient has a history of hepatitis B infection, GAZYVA could cause it to return. Patients should not receive GAZYVA if they have active hepatitis B liver disease. The patient’s doctor or healthcare team will need to screen them for hepatitis B before, and monitor the patient for hepatitis during and after, their treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes

Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. The patient’s weakened immune system could put them at risk. The patient’s doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems

Who should not receive GAZYVA:

Patients should NOT receive GAZYVA if they have had an allergic reaction (e.g., anaphylaxis or serum sickness) to GAZYVA. Patients must tell their healthcare provider if they have had an allergic reaction to obinutuzumab or any other ingredients in GAZYVA in the past.

Additional possible serious side effects of GAZYVA:

Patients must tell their doctor right away about any side effect they experience. GAZYVA can cause side effects that may become severe or life-threatening, including:

Infusion-Related Reactions: These side effects may occur during or within 24 hours of any GAZYVA infusion. Some infusion-related reactions can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening infusion-related reactions. If the patient has a reaction, the infusion is either slowed or stopped until their symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the infusion-related reaction is life-threatening, the infusion of GAZYVA will be permanently stopped. The patient’s healthcare team will take steps to help lessen any side effects the patient may have to the infusion process. The patient may be given medicines to take before each GAZYVA treatment. Symptoms of infusion-related reactions may include: fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort

Hypersensitivity Reactions Including Serum Sickness: Some patients receiving GAZYVA may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, the patient’s doctor will stop the infusion and permanently discontinue GAZYVA

Serious, Including Fatal, Infections: While the patient is taking GAZYVA, they may develop infections. Some of these infections may be fatal and severe, so the patient should be sure to talk to their doctor if they think they have an infection. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients with an active infection should not be treated with GAZYVA. Patients taking GAZYVA plus standard therapy may be at higher risk for fatal or severe infections compared to patients taking standard therapy plus placebo. If you develop a serious infection, your doctor will immediately discontinue GAZYVA and begin treatment for the infection

Low White Blood Cell Count: When the patient has an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While the patient is taking GAZYVA, their doctor will do blood work to check their white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with GAZYVA. Some cases of neutropenia can last for more than one month. If the patient’s white blood cell count is low, their doctor may prescribe medication to help prevent infections

Low Platelet Count: Platelets help stop bleeding or blood loss. GAZYVA may reduce the number of platelets the patient has in their blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While the patient is taking GAZYVA, their doctor will do blood work to check their platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with GAZYVA. Fatal bleeding events have occurred in patients treated with GAZYVA. If the patient’s platelet count gets too low, their treatment may be delayed or reduced

Disseminated Intravascular Coagulation (DIC): Fatal and severe DIC has been reported in people receiving GAZYVA. DIC is a rare and serious abnormal blood clotting condition that should be monitored and managed by the patient’s doctor as it can lead to uncontrollable bleeding

The most common side effects of GAZYVA in LN were upper respiratory tract infection, COVID-19, urinary tract infection, bronchitis, pneumonia, infusion infusion-related reactions, and neutropenia.

Before receiving GAZYVA, patients should talk to their doctor about:

Immunizations: Before receiving GAZYVA therapy, the patient should tell their healthcare provider if they have recently received or are scheduled to receive a vaccine. Patients who are treated with GAZYVA should not receive live vaccines

Pregnancy: The patient should tell their doctor if they are pregnant, think that they might be pregnant, plan to become pregnant, or are breastfeeding. GAZYVA may harm their unborn baby. The patient should speak to their doctor about using GAZYVA while they are pregnant. The patient should talk to their doctor or their child’s doctor about the safety and timing of live virus vaccinations to their infant if they received GAZYVA during pregnancy. Women of childbearing potential should use effective contraception while taking GAZYVA and for 6 months after your GAZYVA treatment

Breastfeeding: Because of the potential risk of serious side reactions in breastfed children, patients should not breastfeed while taking GAZYVA and for 6 months after your last dose

Patients should tell their doctor about any side effects.

These are not all of the possible side effects of GAZYVA. For more information, patients should ask their doctor or pharmacist.

GAZYVA is available by prescription only.

Report side effects to the FDA at (800) FDA-1088, or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Please visit https://www.GAZYVA.com for the GAZYVA full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.

About Genentech in Immunology

Genentech is committed to harnessing pioneering science and innovation to address critical unmet needs for patients with immune-mediated inflammatory diseases. Our pipeline includes over a dozen of clinical programs in immunology aiming to transform care for people living with lupus, MASH, ulcerative colitis, Crohn’s disease, immunoglobulin A nephropathy, idiopathic nephrotic syndrome, atopic dermatitis, and rheumatoid arthritis. We are investing end-to-end in immunology from discovery and R&D to commercialization across a variety of modalities including monoclonal antibodies, bispecifics, and CAR-T cell therapies to help solve some of the most difficult challenges in immunology today.

About Genentech

Founded nearly 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

, /PRNewswire/ -- ZEEKR Intelligent Technology Holding Limited ("Zeekr Group" or the "Company") (NYSE: ZK), the world's leading premium new energy vehicle group, today announced that it will report its unaudited financial results for the third quarter ended September 30, 2025, before the U.S. markets open on Monday, November 17, 2025.

About Z eekr Group

Zeekr Group, headquartered in Zhejiang, China, is the world's leading premium new energy vehicle group from Geely Holding Group. With two brands, Lynk & Co and Zeekr, Zeekr Group aims to create a fully integrated user ecosystem with innovation as a standard. Utilizing its state-of-the-art facilities and world-class expertise, Zeekr Group is developing its own software systems, e-powertrain and electric vehicle supply chain. Zeekr Group's values are equality, diversity, and sustainability. Its ambition is to become a true global new energy mobility solution provider.

For more information, please visit https://ir.zeekrgroup.com.

Safe Harbor Statement

This press release contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement. In some cases, forward-looking statements can be identified by words or phrases such as "may," "will," "expect," "anticipate," "future," "target," "aim," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to," or other similar expressions. Further information regarding these and other risks, uncertainties or factors is included in the Company's filings with the SEC. All information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law.

Investor Relations Contact

In China:

ZEEKR Intelligent Technology Holding Limited
Investor Relations
Email: [email protected]

Piacente Financial Communications
Tel: +86-10-6508-0677
Email: [email protected]

In the United States:

Piacente Financial Communications
Brandi Piacente
Tel: +1-212-481-2050
Email: [email protected]

Media Contact

Email: [email protected]

SOURCE ZEEKR Intelligent Technology Holding Limited

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Sanofi’s high-dose influenza vaccine demonstrates superior protection for older adults against hospitalization vs standard-dose

Compared to standard-dose influenza vaccines, Efluelda/Fluzone High-Dose demonstrated a reduction in laboratory-confirmed influenza hospitalizations by an additional 31.9% (95% CI, 19.7 to 42.2; p<0.001) in adults 65 years and overResults come from FLUNITY-HD, the largest influenza vaccine effectiveness study of individually randomized older adults, involving nearly half a million participants across several seasons and two geographic areasEfluelda/Fluzone High-Dose also provided superior protection, compared to standard-dose influenza vaccines*, against hospitalizations due to pneumonia or influenza, hospitalizations caused by cardio-respiratory events, and all-cause hospitalizations in older adults Efluelda/Fluzone High-Dose is the first vaccine to demonstrate superior protection against both influenza infection and hospitalizations, compared to standard-dose influenza vaccines, in individually randomized studies in adults 65 years and over Paris, October 20, 2025. New data from the FLUNITY-HD study, published on October 17 in The Lancet, demonstrated that Sanofi's Efluelda (known as Fluzone High-Dose in North America) significantly reduced the risk of hospitalization in adults 65 years and older compared to standard-dose influenza vaccines. The largest study of its kind, conducted across multiple seasons, FLUNITY-HD provides robust evidence that the high-dose influenza vaccine offers superior protection compared to standard-dose:

8.8% (95% CI, 1.7 to 15.5; one-sided p=0.008) additional protection against pneumonia/influenza hospitalizations6.3% (95% CI, 2.5 to 10.0; p<0.001) additional reduction in hospitalizations for cardio-respiratory events31.9% (95% CI, 19.7 to 42.2; p<0.001) additional reduction in lab-confirmed influenza hospitalizations2.2% (95% CI, 0.3 to 4.1; p=0.012) additional protection against all-cause hospitalizations, meaning one additional hospitalization could be averted for every 515 (95% CI, 278 to 3,929) individuals vaccinated with Efluelda instead of standard-dose. "The FLUNITY-HD study, unparalleled in its design and scale, harnesses the power and scientific rigor of individual randomization in real-world settings,” shared Professor Tor Biering-Sørensen, Cardiologist, Chief Investigator, and sponsor of the FLUNITY-HD study. “This first-of-its-kind study assessed the benefits of the high-dose influenza vaccine against severe outcomes compared to standard-dose, including against cardio-respiratory hospitalizations, in a randomized setting, covering two geographic areas. The results provide critical evidence, potentially reshaping public health strategies and clinical guidelines."

Professor Federico Martinon-Torres, Co-Principal Investigator of FLUNITY-HD study, added, “This new evidence reinforces the clinical confidence healthcare professionals have that the high-dose influenza vaccine achieves superior protection over standard-dose against severe outcomes in older adults, a group considered vulnerable due to having a weakened immune system and a higher risk of developing serious complications after flu infection."

Beyond clinical evidence, these findings point to potential public health and societal benefits.

“Adults 65 and older represent up to 70% of flu hospitalizations. The FLUNITY-HD data confirm that our high-dose flu vaccine provides superior protection against hospitalizations compared to standard-dose vaccines in older adults,” said Bogdana Coudsy, MD, Global Head of Medical, Sanofi, Vaccines. “For every 515 older adults who receive our high-dose flu vaccine instead of standard-dose vaccines, one all-cause hospitalization is prevented. This can mean a lot, especially for vulnerable seniors, decreasing the burden on their quality of life and helping them to maintain their autonomy for longer. Additionally, preventing influenza hospitalizations may bring societal benefits such as lower healthcare costs, less pressure on medical systems, and reduced burden on caregivers.”

With the addition of these new data, comprehensive research on our high-dose influenza vaccine covers 15 years of clinical evidence spanning over 45 million older adults.

About the FLUNITY-HD Study
FLUNITY-HD is a pre-specified pooled analysis of two pragmatic individually randomized trials involving 466,320 participants aged 65 and older: DANFLU-2 and GALFLU. DANFLU-2 was conducted over three influenza seasons (2022-23, 2023-24 and 2024-25) with over 332,000 participants aged 65 and above in Denmark. GALFLU was conducted over two influenza seasons (2023-24 and 2024-25) with over 134,000 participants aged 65 to 79 in the region of Galicia in Spain.

The largest influenza vaccine study of its kind, this multi-season analysis is designed to evaluate the real-world effectiveness of Efluelda (high-dose influenza vaccine) compared to standard-dose influenza vaccines in preventing hospitalizations, ensuring scientific rigor through individual randomization.

FLUNITY-HD achieved its primary endpoint, demonstrating 8.8% additional protection against pneumonia/influenza hospitalizations (vs standard dose). Secondary endpoints include reduction in hospitalizations for cardio-respiratory events, lab-confirmed influenza hospitalizations and all-cause hospitalizations.

About Efluelda / Fluzone High-Dose
Efluelda is a high-dose influenza vaccine, indicated for adults aged 60 and older in Europe. It is also licensed under the brand name Fluzone High-Dose in North America where it is indicated for adults aged 65 and older.

This high-dose influenza vaccine is specifically tailored for older adults whose immune systems gradually decline and weaken with age, increasing their risk for severe influenza-related illness and hospitalization compared with younger populations. It provides 4x the antigen compared to a standard-dose vaccine to deliver a better immune response against influenza for older adults.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.

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Press Release

Tecentriq reduced the risk of death by 41% and the risk of disease recurrence or death by 36% compared with placebo1IMvigor011 is the first global phase III study to read out pioneering a ctDNA- guided approach to post-surgery treatment in muscle-invasive bladder cancerData being presented as part of the Presidential Symposium at the ESMO Congress 2025 Basel, 20 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the phase III IMvigor011 study evaluating Tecentriq® (atezolizumab) as an adjuvant treatment for people with muscle-invasive bladder cancer (MIBC) who are at risk of recurrence after surgery (cystectomy) and have detectable circulating tumour DNA (ctDNA). In this ctDNA-guided setting, Tecentriq reduced the risk of death (overall survival, OS) by 41% and the risk of disease recurrence or death (disease-free survival, DFS) by 36%, both compared with placebo. This ctDNA-guided approach, using Natera’s SignateraTM ctDNA Molecular Residual Disease (MRD) test, spared people at low risk of recurrence from unnecessary treatment and side effects. The safety profile was consistent with previous studies of Tecentriq.1

These results are being presented as part of the Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2025. They will also be discussed with health authorities, including the U.S. Food and Drug Administration (FDA).

“These clinically meaningful results show that Tecentriq helped people with muscle-invasive bladder cancer live longer and without their disease returning,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “The use of serial ctDNA testing to detect molecular residual disease may also advance bladder cancer treatment by combining a precision diagnostic with cancer immunotherapy.”

“Even after surgery, most people with muscle-invasive bladder cancer will face the physical and emotional toll of further treatment,” said Professor Thomas Powles, lead principal investigator of IMvigor011, Professor of Genitourinary Oncology; Chair of Barts Cancer Centre at St. Bartholomew's Hospital. “These results indicate that with Signatera ctDNA testing, we may be able to identify those at risk of recurrence who could benefit from adjuvant atezolizumab treatment and spare others from unnecessary therapy, paving the way for a more personalised treatment approach.”

At median follow up of 16.1 months, median DFS was 9.9 months in the Tecentriq arm versus 4.8 months in the placebo arm (stratified hazard ratio [HR]=0.64; 95% CI: 0.47-0.87, p =0.0047). Median OS was 32.8 months in the Tecentriq arm versus 21.1 months in the placebo arm (HR=0.59; 95% CI: 0.39-0.90, p=0.0131). People who persistently tested for no detectable ctDNA had low risk of recurrence.1

More than 150,000 people worldwide are diagnosed with MIBC each year.2,3 It is an aggressive type of cancer, with poor long-term outcomes and high treatment burden.4 Despite this, personalised treatment approaches lag behind other cancer types.5 ctDNA-guided treatment could change this, by helping healthcare professionals tailor treatment more precisely to improve clinical benefit and reduce unnecessary intervention.1

About the IMvigor011 study
IMvigor011 [NCT04660344] is a global phase III, randomised, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with Tecentriq® (atezolizumab) compared with placebo in participants with muscle-invasive bladder cancer (MIBC) who are circulating tumour DNA (ctDNA)-positive and are at risk of recurrence following cystectomy. IMvigor011 utilised Natera’s SignateraTM as the clinical trial assay. This personalised ctDNA test for the detection of MRD is currently under review by the FDA for use as a companion diagnostic. 761 people participated in the surveillance phase of IMvigor011 and those with positive Signatera tests (250 people) joined the treatment phase, where they received either Tecentriq or placebo. The primary endpoint is investigator-assessed disease-free survival (DFS). Secondary endpoints include overall survival (OS) and tolerability, amongst others.

About Tecentriq® (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq has been approved for some of the most aggressive and difficult-to-treat forms of cancer and is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer (mUC), PD-L1-positive metastatic triple-negative breast cancer (TNBC), BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma (ASPS).

About Roche in cancer immunotherapy
To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link: https://www.roche.com/solutions/focus-areas/oncology/cancer-immunotherapy

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Powles T, et al. IMvigor011: a Phase 3 trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer. To be presented at: ESMO Congress; 2025 Oct 17-21; Berlin, Germany. Abstract #LBA8.
[2] Global Cancer Observatory. Cancer Today GLOBOCAN 2022 Factsheet – Bladder [Internet; cited 2025 October]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/30-bladder-fact-sheet.pdf.
[3] Ghandour R, et al. Treatment Options and Outcomes in Nonmetastatic Muscle Invasive Bladder Cancer. Trends Cancer. 2019;5(7):426-39.
[4] Vogl U, et al. Current advances in the perioperative treatment of muscle-invasive bladder cancer. Healthbook TIMES Oncol. Hematol. 2025;24(2):54-63.
[5] Van Hoogstraten LMC, et al. Global trends in the epidemiology of bladder cancer challenges for public health and clinical practice. Nat Rev Clin Oncol. 2023;20:287-304.

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Media & Investor Release IMvigor011 ESMO

Semiconductor stocks have been the biggest beneficiaries of rising investment in artificial intelligence (AI) infrastructure over the last three years.

When investors think about artificial intelligence (AI) hardware stocks, Nvidia understandably dominates the conversation. Yet beneath the surface, another semiconductor powerhouse is making impressive strides.

Advanced Micro Devices (AMD -0.52%) has transformed from a longtime challenger in graphics processing units (GPUs) and central processing units (CPUs) into a credible leader in AI accelerators -- the high-performance chips that enable the training and deployment of large language models (LLMs) and generative AI applications.

With a growing line-up of cutting-edge processors and strategic partnerships with major cloud providers, AMD is positioning itself as a top contender in the next wave of AI infrastructure growth.

AMD's position in the AI accelerator race
Nvidia remains the undisputed leader in the AI hardware market, but AMD is rapidly narrowing the gap. The company's Instinct MI300 chip architecture has already proven capable of competing at the highest performance tiers, and the upcoming MI400 accelerators are expected to deliver meaningful improvements in memory capacity, energy efficiency, and throughput.

These gains aren't just theoretical. Major hyperscalers like Microsoft and Meta Platforms are already integrating AMD's chips into next-generation data center buildouts as an alternative to Nvidia's GPUs.

By embracing open-source standards like ROCm, AMD is creating a more flexible ecosystem that enables developers to move and optimize models seamlessly across platforms. The company's message to customers is clear: Achieve cutting-edge AI performance without being locked into a single vendor's proprietary ecosystem or constrained by Nvidia's supply chain and pricing.

Image source: Advanced Micro Devices.

Megadeals highlight real momentum
Perhaps the clearest validation of AMD's progress in AI hardware comes from two of the most influential names in the industry: OpenAI and Oracle.

Earlier this month, OpenAI announced a 6-gigawatt data center partnership to power its next generation of models using new architectures built on AMD accelerators. Just a week later, Oracle revealed that its cloud infrastructure division would deploy 50,000 Instinct MI450 chips in the second half of next year.

These landmark partnerships highlight two critical points. First, AMD has proven it can deliver AI computing power at hyperscale capacity. Second, the price-performance economics of its chips are now competitive enough to win over top-tier cloud providers and AI developers.

But these deals represent more than headline figures -- they signal a fundamental shift in the AI infrastructure market. Cloud giants are diversifying their GPU supply chains to meet unprecedented demand for compute power, and AMD's ability to deliver large-scale, cost-efficient accelerators makes it an essential pillar in that strategy. In many ways, it's a direct acknowledgement that the future of AI hardware will be multivendor -- and AMD is emerging as a driving force behind that transition.

Building the AI ecosystem: From software to start-ups
AMD understands that hardware alone isn't enough to win the AI revolution. That's why the company has been steadily investing in software, developer tools, and research frameworks that make its chips easier to adopt across enterprises and data centers.

Strategic acquisitions such as Nod.ai and Silo AI have augmented AMD's capabilities in optimization, model deployment, and integration -- essential tools for developers who want to build and scale applications on AMD's systems.

At the same time, the company benefits from a growing AI start-up ecosystem that complements its product roadmap. Companies like Groq are expanding overall demand for specialized computing and setting new benchmarks for inference performance and energy efficiency.

As the industry moves toward flexible AI infrastructure, AMD's Instinct accelerator platform is positioned to capture more market share. In short, AMD isn't just supplying chips -- it's building a complete foundation that aligns with the next phase of data center innovation.

How should investors view AMD stock?
For investors, AMD represents a compelling balance of growth potential and market validation. The company has proven it can compete head-to-head with Nvidia while maintaining a steady cadence of innovation -- with its next-generation MI450 chips set to really make a splash next year.

While near-term volatility is possible given the massive capital investment fueling the semiconductor industry, AMD's long-term trajectory looks promising. The company is no longer the underdog; it has become a cornerstone of the AI infrastructure buildout that will define the next decade of computing.

For long-term investors who believe the AI boom is still in its early innings, AMD stands out as one of the best AI hardware stocks to buy today -- a company bridging world-class engineering with expanding real-world demand across cloud computing, data centers, and generative AI models.

Adam Spatacco has positions in Meta Platforms, Microsoft, and Nvidia. The Motley Fool has positions in and recommends Advanced Micro Devices, Meta Platforms, Microsoft, Nvidia, and Oracle. The Motley Fool recommends the following options: long January 2026 $395 calls on Microsoft and short January 2026 $405 calls on Microsoft. The Motley Fool has a disclosure policy.