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What was the dispute over?

Squamous NSCLC represents roughly 25–30% of lung cancer cases and, unlike adenocarcinoma, has fewer actionable driver alterations. After progression on frontline chemo-immunotherapy, many patients fall back on single-agent docetaxel, which offers modest benefit and meaningful toxicity—creating a clear unmet need for more effective second-line strategies.

Non-Small Cell Lung Cancer: Causes, Symptoms, Diagnosis, Treatment Options, and Latest 2025 Advances in Targeted and Immunotherapy

What Is Gotistobart (BNT316/ONC-392)?

Gotistobart, also known by its research codes BNT316 or ONC-392, is a next-generation anti–CTLA-4 monoclonal antibody jointly developed by BioNTech SE and OncoC4 in late-stage clinical development across several solid tumor indications, including squamous non–small cell lung cancer (NSCLC) and others.

Unlike traditional CTLA-4 inhibitors, gotistobart is engineered to be pH-sensitive and to preserve CTLA-4 recycling. When it binds the CTLA-4 receptor on T cells, the antibody-receptor complex is internalized, but under acidic conditions found inside cells, the antibody dissociates rather than triggering lysosomal degradation of CTLA-4. This allows CTLA-4 to return to the cell surface and preserves its function outside the tumor microenvironment, while preferentially depleting immunosuppressive regulatory T cells (Tregs) within the tumor. This tumor-microenvironment-selective action is intended to enhance anti-tumor immunity while potentially limiting peripheral toxicity relative to conventional CTLA-4 blockade.

Gotistobart is being studied both as monotherapy and in combination with other immunotherapies, and has received regulatory designations—including FDA Fast Track and Orphan Drug status—reflecting its potential in hard-to-treat cancers such as squamous NSCLC.

Why Orphan Drug Designation matters

ODD is intended to accelerate development for therapies targeting rare/high-need populations, providing incentives such as tax credits for qualified clinical testing and (if approved) 7 years of marketing exclusivity in the U.S.

Study Design and Methods

The ODD announcement is supported by efficacy signals from the ongoing PRESERVE-003 trial (NCT05671510), a global, randomized phase 3 study evaluating gotistobart versus standard chemotherapy in metastatic squamous NSCLC after progression on anti–PD-(L)1 therapy.

Results

Phase 3 PRESERVE-003 (dose-confirmation stage; nonpivotal)
At a median follow-up of 14.5 months, gotistobart monotherapy showed a notable overall survival advantage versus docetaxel:

• Median OS: not reached (gotistobart) vs 10.0 months (docetaxel)
• 12-month OS: 63.1% vs 30.3%
• Risk of death: HR 0.46 (95% CI, 0.25–0.84), P = .0102

Safety

In the same dataset, treatment-related toxicity appeared comparable or slightly lower than chemotherapy:

• Grade ≥3 treatment-related AEs: 42.2% (gotistobart) vs 48.8% (docetaxel)

Insights

• If these OS findings hold in the pivotal stage, gotistobart could redefine expectations for post–PD-(L)1, second-line squamous NSCLC, where meaningful OS gains have been difficult to achieve with immunotherapy alone.
• The therapeutic-index engineering (CTLA-4 recycling concept) is the key scientific bet: maintaining anti-tumor CTLA-4 biology while improving tolerability may be what allows CTLA-4 blockade to succeed as monotherapy in a heavily pretreated population.

Key Takeaway Messages

• FDA ODD has been granted to gotistobart for squamous NSCLC.
• In PRESERVE-003 (dose-confirmation stage), gotistobart showed strong OS separation vs docetaxel (HR 0.46; 12-month OS 63.1% vs 30.3%).
• Safety appears manageable and at least comparable to chemotherapy in the reported dataset.
• The program’s differentiator is a pH-sensitive CTLA-4 approach designed around recycling and tumor-selective Treg depletion.

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HIGHLIGHTS

• Following an interim data review of the Cohort Expansion Phase (Phase II) of the SECuRE trial, the Safety Review Committee (SRC) confirms the trial will continue with no modifications to the protocol.

Patient population

• With the SECuRE trial continuing to recruit, a total of nine participants who had evaluable data by the 25^th of November 2025 were included in the interim assessment by the SRC, with the majority of participants receiving at least two cycles of 8 GBq of ⁶⁷Cu-SAR-bisPSMA each by the data cut-off date.
• Seven participants received ⁶⁷Cu-SAR-bisPSMA and two participants were treated with a combination of ⁶⁷Cu-SAR-bisPSMA with enzalutamide.
• Most participants were heavily pre-treated (with 55.6% having received more than 5 previous anti-cancer regimens) and had bone metastasis (66.7%).

Safety

• The safety profile of ⁶⁷Cu-SAR-bisPSMA remains favourable with most related adverse events (AEs) in the Cohort Expansion to date being Grade 1 or 2. The most common AEs were nausea and lymphopenia (observed in 33.3% of participants, for each AE).

Efficacy

• Six participants had at least two prostate specific antigen (PSA) results following ⁶⁷Cu-SAR-bisPSMA administration, with all showing a decrease in PSA. Of those, four participants (66.7%) thus far had a reduction of more than 50% in PSA (PSA50) and two participants (33.3%) had a reduction of more than 80% (PSA80).
• One participant who presented with bone metastasis at enrolment achieved undetectable PSA with no prostate cancer detected by computed tomography (CT) or bone scan following ⁶⁷Cu-SAR-bisPSMA treatment. The participant reported having excellent quality of life following the treatment.

Next Steps

• The SECuRE trial will continue enrolment into the Cohort Expansion Phase with planned completion of recruitment in 2026. Phase III registrational trial planning ongoing based on data generated to date.

SYDNEY, Jan. 15, 2026 /PRNewswire/ — Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “Company”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to share a number of updates on the SECuRE trial following an SRC meeting. The SRC has recommended that the trial continue with the Cohort Expansion Phase (Phase II) as planned with no modifications to the protocol. The interim results assessed by the SRC were collected from nine participants enrolled in the cohort that had evaluable data by the cut-off date of the 25^th of November 2025 and continue to show promising efficacy and a favourable safety profile of ⁶⁷Cu-SAR-bisPSMA.

The majority of the nine participants had bone metastasis at enrolment (66.7%) and received multiple lines of previous treatments (more than 5 previous anti-cancer regimens, 55.6%). Median PSA prior to ⁶⁷Cu-SAR-bisPSMA treatment was 18.9 ng/mL (range 1.5-30.2 ng/mL). Six out of these nine participants received at least 2 cycles of 8 GBq of ⁶⁷Cu-SAR-bisPSMA each, with two of them also receiving concomitant enzalutamide.

Of the nine participants included in this SRC analysis, six had at least two PSA results following their ⁶⁷Cu-SAR-bisPSMA treatment by the data cut-off date. Of these six participants, thus far four (66.7%) showed reductions in PSA of 50% or more (PSA50) and two (33.3%) showed reductions of 80% or more (PSA80).

The safety profile of ⁶⁷Cu-SAR-bisPSMA remains favourable in the Cohort Expansion, with the majority of related AEs being Grade 1 or 2. The most common related AEs were nausea and lymphopenia (observed in three out of nine participants [33.3%], for each AE). The only AE that was Grade 3 or above was lymphopenia observed in three participants, some of whom had bone metastasis at baseline and/or had received multiple lines of therapy, including taxane and an investigational agent, prior to enrolment in the SECuRE study. There have been no overall renal toxicity or electrocardiogram (ECG) changes observed in these participants. In the combination enzalutamide arm, no new AEs (or worsening of AEs) related to ⁶⁷Cu-SAR-bisPSMA have been observed to date.

Trial participant with no detectable disease after 3 cycles of ⁶⁷Cu-SAR-bisPSMA

One of the participants in the Cohort Expansion was a 64-year-old man with bone metastases and baseline PSA of 5.4 ng/mL prior to entering the SECuRE study. Following his first cycle of ⁶⁷Cu-SAR-bisPSMA, this participant showed a dramatic 95.2% reduction in PSA. He went on to receive 2 more cycles of ⁶⁷Cu-SAR-bisPSMA and achieved undetectable PSA levels. In a follow-up bone scan and CT no metastatic disease was observed. This participant only exhibited mild (Grade 1) related AEs, most of which were gastrointestinal events, with no haematological or renal AEs observed. The participant reported having excellent quality of life following the treatment.

The interim data from this Phase II continues to confirm the favourable safety profile and promising efficacy seen in previous cohorts of the SECuRE trial^[1] and supports the continuation of the trial with the aim to progress to a registrational Phase III study.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, “SAR-bisPSMA continues generating world-class data in both theranostic and diagnostic trials. The combination of the optimised dimer ‘bis’ structure with the benefits of copper isotopes, enabled by the proprietary sarcophagine technology, is proving to have created a product that is here to challenge the current treatment and diagnostic paradigms in radiopharmaceuticals.

“We have already seen a glimpse of the effects of ⁶⁷Cu-SAR-bisPSMA through our Dose Escalation cohorts with additional and similar data being generated in the Cohort Expansion phase, demonstrating once again excellent efficacy and safety results of ⁶⁷Cu-SAR-bisPSMA.

“All of the participants with evaluable data treated in the Phase II to date have shown declines in PSA, with the majority showing PSA decreases of more than 50% and mostly having only mild or moderate AEs. Most of these patients have been treated with more than 5 systemic treatment regiments and had bone metastasis prior to entering the SECuRE study. Although the number of participants with evaluable data to date is small, it is incredible to see yet another extraordinary case where a patient who had bone metastasis prior to entering the study achieved undetectable PSA following ⁶⁷Cu-SAR-bisPSMA treatment, with no disease observed by anatomical and molecular imaging at the last assessments. This participant only experienced mild, transient AEs, most being gastrointestinal, and has reported having excellent quality of life following the treatment.

“Importantly, the work we have undertaken during the Dose Escalation Phase is now continuing to provide a strong foundation for us as we look ahead at protocol development and dosing for our Phase III clinical trial and commercialisation. As the participant numbers continue to increase with the trial enrollment, we continue to see very promising responses over and over again, giving us more confidence about the future of this product and its potential for commercialisation in metastatic castration-resistant prostate cancer (mCRPC). With three Fast Track Designations for the SAR-bisPSMA product and positive interactions with the US Food and Drug Administration (FDA) to date, we are working towards bringing this agent to clinicians and their patients around the world through the entirety of the prostate cancer journey, from first diagnosis to late-stage disease. All of these indications, being imaging in pre-definitive therapy and biochemical recurrence, as well as therapy in mCRPC, are blockbuster markets individually for prostate-specific membrane antigen (PSMA) targeted products, with an estimated combined market value of approximately US$10-15 billion by 2030. We are committed to continuing the development of this product, aiming to bring improved diagnostic and treatment options for prostate cancer in various stages of their disease.”

About the SECuRE trial

The SECuRE trial (NCT04868604)^[2] is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using ⁶⁴Cu/⁶⁷Cu-SAR-bisPSMA. ⁶⁴Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent ⁶⁷Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion involving approximately 54 participants in the US. The overall aim of the trial is to determine the safety and efficacy of ⁶⁷Cu-SAR-bisPSMA for the treatment of prostate cancer.

The SECuRE trial consists of the Dose Escalation (Phase I) and Cohort Expansion (Phase II) Phases. Based on the data from the Dose Escalation Phase, which demonstrated a favourable safety profile and efficacy of ⁶⁷Cu-SAR-bisPSMA, the SECuRE trial progressed to the Cohort Expansion (Phase II) at an 8 GBq dose level as per the SRC recommendation (up to 6 cycles per patient in total)^[3].

Cohort 2 of the Dose Escalation phase of the trial, where participants were dosed with 8 GBq of ⁶⁷Cu-SAR-bisPSMA, demonstrated a very low rate of related AEs while all three participants achieved PSA declines of 80% or more (PSA80)^[1]. The Dose Escalation Phase also showed high PSA response rates of the mCRPC in the pre-chemotherapy setting with a favourable safety profile: 92% of pre-chemotherapy participants (12/13) demonstrated PSA drops greater than 35%, PSA reductions greater than 50% were reached in 61.5% (8/13) of participants, and reductions of 80% or more were achieved in 46.2% (6/13) of participants^[1]. These results supported the progress of the trial to its Cohort Expansion Phase using 8 GBq multi-dose in participants who had not received chemotherapy in the mCRPC setting.

Recruitment is currently ongoing into the Cohort Expansion Phase which will include 24 participants. A subset of participants will be treated with the combination of 8 GBq of ⁶⁷Cu-SAR-bisPSMA with enzalutamide (androgen receptor pathway inhibitor [ARPI]), in line with the positive results from the Enza-p trial^[4] and previous discussions with and advice from key global medical experts in the field of prostate cancer, including the Company’s Clinical Advisory Board members, Prof Louise Emmett and Prof Oliver Sartor, as well as the SRC.

About SAR-bisPSMA

SAR-bisPSMA derives its name from the word “bis”, which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or ⁶⁴Cu) for imaging and copper-67 (Cu-67 or ⁶⁷Cu) for therapy.

⁶⁷Cu-SAR-bisPSMA and ⁶⁴Cu-SAR-bisPSMA are unregistered products. The safety and efficacy of ⁶⁷Cu-SAR-bisPSMA and ⁶⁴Cu-SAR-bisPSMA have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that these products will become commercially available.

About Prostate Cancer

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide^[5]. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the US and around 35,770 deaths from the disease^[6].

About Clarity Pharmaceuticals

Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing TCTs based on its SAR Technology Platform for the treatment of cancers.

www.claritypharmaceuticals.com

For more information, please contact:

References

1. Clarity Pharmaceuticals. SECuRE trial update: 92% of pre-chemo participants experience greater than 35% drop in PSA levels across all cohorts. Cohort Expansion Phase commences. https://www.claritypharmaceuticals.com/news/secure-update/
2. ClinicalTrials.gov Identifier: NCT04868604, https://clinicaltrials.gov/ct2/show/NCT04868604
3. Clarity Pharmaceuticals. SECuRE trial update: First patient treated in the Phase II Cohort Expansion. https://www.claritypharmaceuticals.com/news/secure-fp-phase2/
4. Emmett L et al. ENZA-p Trial Investigators; Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Overall survival and quality of life with [¹⁷⁷Lu]Lu-PSMA-617 plus enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer (ENZA-p): secondary outcomes from a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2025 Mar;26(3):291-299. doi: 10.1016/S1470-2045(25)00009-9.
5. Global Cancer Statistics 2022: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834
6. American Cancer Society: Key Statistics for Prostate Cancer. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html

This announcement has been authorised for release by the Executive Chairperson.

SOURCE Clarity Pharmaceuticals

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Acquisition to expand Boston Scientific’s cardiovascular portfolio and further address increasing prevalence of vascular diseases

Provides scaled entry into mechanical thrombectomy and neurovascular, key strategic adjacencies

Conference call at 8:00 a.m. ET to discuss details of the transaction

MARLBOROUGH, Mass. and ALAMEDA, Calif., Jan. 15, 2026 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) and Penumbra, Inc., (NYSE: PEN) today announced the companies have entered into a definitive agreement under which Boston Scientific will acquire Penumbra in a cash and stock transaction that values Penumbra at $374 per share, reflecting an enterprise value of approximately $14.5 billion.ⁱ

“Penumbra is a well-established company with an experienced, high-performing team and this acquisition offers Boston Scientific an opportunity to enter new, fast-growing segments within the vascular space,” said Mike Mahoney, chairman and chief executive officer, Boston Scientific. “I’m thrilled to combine the talents and shared values of our teams – including welcoming Penumbra’s chairman and chief executive officer, Adam Elsesser, to our board of directors upon close. The addition of Penumbra can expand access for these novel technologies to more patients and customers around the world, further enhancing our revenue and margins over time with proven offerings that have a history of growth and innovation.”

Cardiovascular diseases are the leading cause of death globallyⁱⁱ and include disorders of the heart and blood vessels that can restrict blood flow and increase the risk of clots throughout the body. To address the escalating prevalence of these complex diseases, Penumbra has developed a comprehensive portfolio that includes differentiated devices to treat conditions such as pulmonary embolism, stroke, deep vein thrombosis, acute limb ischemia, heart attack and aneurysms.

Penumbra offers innovative mechanical thrombectomy products for use in peripheral vascular procedures to remove blood clots causing blockages in arterial, venous and pulmonary vessels, including the Lightning Bolt^® and Lightning Flash^® computer assisted vacuum thrombectomy (CAVT™) systems. The company’s vascular portfolio also includes a minimally invasive peripheral embolization system, which is designed to stop blood flow to control hemorrhaging and bleeding or to close blood vessels.

Neurovascular offerings from Penumbra currently include differentiated solutions for access, stroke revascularization and neuro embolization. The company is continuing to innovate in these areas and add meaningful clinical evidence to support expanded access for more patients worldwide.

“Our decades-long development of therapies for challenging medical conditions has focused on deep innovation for complex diseases so that we can offer physicians novel solutions to transform patient care,” said Adam Elsesser. “I am grateful for the amazing people who have contributed to this work and look forward to uniting our efforts and shared values as we come together with Boston Scientific.”  

Penumbra expects to deliver fourth quarter reported revenue growth in the range of approximately 21.4% – 22.0% and full year 2025 reported revenue of approximately $1.4 billion, representing growth in the range of approximately 17.3% – 17.5% over the prior fiscal year.ⁱⁱⁱ Penumbra continues to advance its technologies with a multi-year research and development plan and ongoing clinical programs.

Under the terms of the agreement, which has been approved by the board of directors of each company, the transaction values each Penumbra share at $374, with Penumbra stockholders having the right to elect to receive $374 in cash or 3.8721 shares of Boston Scientific common stock (valued at $374 based on the volume weighted average price of Boston Scientific common stock over the last 10 trading days, as of January 13, 2026), subject to proration, so that the total transaction consideration is paid approximately 73% in cash and approximately 27% in shares of Boston Scientific common stock. Adam Elsesser has indicated that he will elect to receive Boston Scientific shares for all his Penumbra shares.

Boston Scientific expects to finance the approximately $11 billion cash portion of the transaction consideration with a combination of cash on hand and new debt. The transaction is expected to be $0.06-0.08 dilutive to adjusted earnings per share for Boston Scientific in the first full year following the close of the acquisition, neutral to slightly accretive in the second year and more accretive thereafter. The impact to GAAP earnings per share is expected to be dilutive in the first full year following the close, and less dilutive or increasingly accretive thereafter, as the case may be, due to amortization expense and acquisition-related net charges. 

The transaction is expected to be completed in 2026, subject to receipt of Penumbra’s stockholder approval and the satisfaction of other customary closing conditions.

Boston Scientific will be discussing this announcement on a conference call today at 8:00 a.m. ET, which can be accessed on the Events and Presentations section of the Boston Scientific investor relations website along with additional information about this transaction.  

Allen Overy Shearman & Sterling LLP and Arnold & Porter Kaye Scholer LLP are serving as legal advisors to Boston Scientific.

Perella Weinberg Partners is serving as exclusive financial advisor to Penumbra and Davis Polk & Wardwell LLP is serving as legal advisor.

About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.  

About Penumbra
Penumbra, Inc., the world’s leading thrombectomy company, is focused on developing the most innovative technologies for challenging medical conditions such as ischemic stroke, venous thromboembolism such as pulmonary embolism, and acute limb ischemia. Our broad portfolio, which includes computer assisted vacuum thrombectomy (CAVT), centers on removing blood clots from head-to-toe with speed, safety and simplicity. By pioneering these innovations, we support healthcare providers, hospitals and clinics in more than 100 countries, working to improve patient outcomes and quality of life. For more information, visit www.penumbrainc.com and connect on Instagram, LinkedIn, and X.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words.  These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance.  These forward-looking statements include, among other things, statements regarding the financial and business impact of the transaction and anticipated benefits of the transaction, the closing of the transaction and the timing thereof, business plans and strategy, product launches and product performance and impact, clinical programs, and expected financial results.  If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements.  These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release.  As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. 

Factors that may cause such differences include, among other things: economic conditions, including the impact of foreign currency fluctuations; future U.S. and global political, competitive, reimbursement and regulatory conditions, including changing trade and tariff policies; geopolitical events; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by public health emergencies or extreme weather or other climate change-related events; labor shortages and increases in labor costs; variations in outcomes of ongoing and future clinical trials and market studies; new product introductions; expected procedural volumes; the closing and integration of acquisitions, including the ability to achieve the anticipated benefits of the proposed transaction and successfully integrate Penumbra’s operations; business disruptions (including disruptions in relationships with employees, customers or suppliers) following the announcement and/or closing of the proposed transaction; demographic trends; intellectual property; litigation; financial market conditions; future business decisions made by us and our competitors; the conditions to the completion of the proposed transaction, including the receipt of the required regulatory approvals and clearances, may not be satisfied at all or in a timely manner; and the closing of the proposed transaction may not occur or may be delayed.  All of these factors are difficult or impossible to predict accurately and many of them are beyond our control.  For a further list and description of these and other important risks and uncertainties that may affect each of Boston Scientific’s and Penumbra’s businesses and future operations, see Part I, Item 1A – Risk Factors in Boston Scientific’s and Penumbra’s respective most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which may be updated in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q each company has filed or will file hereafter.  Boston Scientific and Penumbra each disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements, except as required by law.  This cautionary statement is applicable to all forward-looking statements contained in this document.

Important Information and Where to Find It

In connection with the proposed transaction, Boston Scientific will file with the Securities and Exchange Commission (the “SEC“) a registration statement on Form S-4 that will include a proxy statement/prospectus (the “Proxy Statement/Prospectus“) for the stockholders of Penumbra, and Penumbra will mail the Proxy Statement/Prospectus to its stockholders and file other documents regarding the proposed transaction with the SEC. This communication is not a substitute for any proxy statement, registration statement, proxy statement/prospectus or other documents Boston Scientific and/or Penumbra may file with the SEC in connection with the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ CAREFULLY AND IN THEIR ENTIRETY THE PROXY STATEMENT/PROSPECTUS WHEN IT BECOMES AVAILABLE, ANY AMENDMENTS OR SUPPLEMENTS TO THE PROXY STATEMENT/PROSPECTUS, AND OTHER DOCUMENTS FILED BY BOSTON SCIENTIFIC OR PENUMBRA WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION, BECAUSE THESE DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders will be able to obtain free copies of the Proxy Statement/Prospectus and other documents filed with the SEC by Boston Scientific and/or Penumbra through the website maintained by the SEC at www.sec.gov. Security holders will also be able to obtain free copies of the documents filed by Boston Scientific with the SEC on Boston Scientific’s website at investors.bostonscientific.com or by contacting Boston Scientific Investor Relations at BSXInvestorRelations@bsci.com or by calling 508-683-4479. Security holders will also be able to obtain free copies of the documents filed by Penumbra with the SEC on Penumbra’s website at https://www.penumbrainc.com/investors/sec-filings/ or by contacting Penumbra Investor Relations at investors@penumbrainc.com.

No Offer or Solicitation

This communication is for informational purposes only and not intended to and does not constitute an offer to subscribe for, buy or sell, the solicitation of an offer to subscribe for, buy or sell or an invitation to subscribe for, buy or sell any securities or the solicitation of any vote or approval in any jurisdiction pursuant to or in connection with the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law.

Participants in the Solicitation

Boston Scientific, Penumbra and certain of their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from Penumbra’s stockholders in connection with the proposed transaction. Information regarding Boston Scientific’s directors and executive officers, including a description of their respective direct or indirect interests, by security holdings or otherwise, will be set forth in the Joint Proxy Statement/Prospectus and other relevant materials when they are filed with the SEC. These documents (when available) may be obtained free of charge from the SEC’s website at www.sec.gov or by accessing the Investor Relations section of the Boston Scientific website at investors.bostonscientific.com. Information regarding the Boston Scientific’s directors and executive officers is contained in the sections entitled “Election of Directors” and “Securities Ownership of Director and Executive Officers” included in Boston Scientific’s proxy statement for its 2025 annual meeting of stockholders, which was filed with the SEC on March 19, 2025 (and which is available at https://www.sec.gov/ix?doc=/Archives/edgar/data/885725/000088572525000017/bsx-20250319.htm), in the section entitled “Directors, Executive Officers and Corporate Governance” included in Boston Scientific’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on February 18, 2025 (and which is available at https://www.sec.gov/ix?doc=/Archives/edgar/data/885725/000088572525000011/bsx-20241231.htm), in Boston Scientific’s Form 8-K filed on April 23, 2025 (and which is available at https://www.sec.gov/ix?doc=/Archives/edgar/data/885725/000088572525000024/bsx-20250418.htm), in Boston Scientific’s Form 8-K filed on September 4, 2025 (and which is available at https://www.sec.gov/ix?doc=/Archives/edgar/data/885725/000088572525000043/bsx-20250829.htm), and in the Boston Scientific’s Form 8-K filed on October 23, 2025 (and which is available at https://www.sec.gov/ix?doc=/Archives/edgar/data/885725/000088572525000048/bsx-20251022.htm). To the extent holdings of Boston Scientific securities by the directors and executive officers of Boston Scientific have changed from the amounts of securities of Boston Scientific held by such persons as reflected therein, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. Information regarding Penumbra’s directors and executive officers is contained in the sections entitled ““Proposal No. 1: Election of Directors“, “Information Regarding the Board of Directors and Corporate Governance“, and “Other Information Related to Penumbra, Its Directors and Executive Officers” included in Penumbra’s proxy statement for its 2025 annual meeting of stockholders, filed with the SEC on April 16, 2025 (and which is available at https://www.sec.gov/ix?doc=/Archives/edgar/data/1321732/000132173225000074/pen-20250416.htm), in the section entitled “Directors, Executive Officers and Corporate Governance” included in Penumbra’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on February 18, 2025 (and which is available at https://www.sec.gov/ix?doc=/Archives/edgar/data/1321732/000132173225000012/pen-20241231.htm), and in Penumbra’s Form 8-K filed on August 27, 2025 (and which is available at https://www.sec.gov/ix?doc=/Archives/edgar/data/1321732/000132173225000101/pen-20250822.htm). To the extent holdings of Penumbra securities by the directors and executive officers of Penumbra have changed from the amounts of securities of Penumbra held by such persons as reflected therein, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC.

CONTACTS

Boston Scientific:
Laura Aumann
Media Relations
+1 (651) 582-4251
laura.aumann@bsci.com   

Lauren Tengler
Investor Relations
+1 (508) 683-4479
BSXInvestorRelations@bsci.com

Penumbra:
Jennifer Heth
Media Relations
+1 (510) 995-9791
jheth@penumbrainc.com

Jason Mills 
Investor Relations
+1 (925) 826-7933
jmills1@penumbrainc.com

ⁱ Enterprise value based on 39.2 million common shares outstanding and vesting of shares under Penumbra’s equity incentive plans for a total fully diluted share count of approximately 40.0 million shares, implying $15 billion for 100% of the fully diluted equity, minus approximately $470 million net cash and short-term investments as of September 30, 2025.
ⁱⁱ Cardiovascular diseases (CVDs) (who.int)
ⁱⁱⁱ Penumbra, Inc. (2025). Penumbra, Inc. Provides Preliminary Update on Fourth Quarter and Full Year 2025 Financial Results. https://www.penumbrainc.com/investors/press-releases/.

 

SOURCE Boston Scientific Corporation

However, the equation is not yet balanced.

75% state current telecom infrastructure limits the ability to deliver on those ambitions. 45% suggest these limitations would delay, constrain, or entirely limit investments.

There is clearly a disconnect between the ambition and the ability to deliver. 

At present, Europe lags the US and parts of Asia in areas such as network deployment, related investment levels, and scale.

What we must remember primarily is that AI does not happen without advanced, trusted and future-proofed networks. Infrastructure is not a “nice to have” it is a fundamental part. 

If AI does not reach its full potential, EU competitiveness will suffer, economic growth will have a ceiling, the creation of new jobs will have a limit, and consumers will not see the benefits.

When we asked businesses during for our research, out of 15 potential options, the lack of adequate connectivity infrastructure came fourth.

Our telecom connectivity regulatory approach must be more closely aligned with the goal of fostering AI. That means progressing towards a genuine telecom single market, adopt a novel approach to competition policy to allow market consolidation leading to more investments, and ensuring connectivity is always secure and trusted.

Leading global law firm Baker McKenzie has published its annual Global Disputes Forecast, highlighting the challenges of operating in a global environment. Geopolitical pressures are heavily influencing disputes risks, and 82% of organizations are concerned about being subject to a cross-border or multiagency investigation in 2026. In addition, respondents point to cybersecurity and tax as their top dispute and investigation risk areas this year across a diverse, high-stakes risk portfolio. 

The Firm’s Forecast, now in its ninth year, is based on a survey of 600 senior in-house lawyers from industry-leading multinationals across several sectors, including industrials, manufacturing and transportation; consumer goods and retail; healthcare and life sciences; technology, media and telecoms; financial institutions; and energy, mining and infrastructure.

Key Findings

The latest Global Disputes Forecast highlights that organizations are entering 2026 feeling disputes pressures from all sides. Alongside technology-related risk and operational and supply chain disruption, geopolitics and trade policy are also central concerns, with 79% of respondents identifying tariffs, sanctions and export controls as major external market factors increasing their exposure to disputes. This geopolitical reality is driving fears of cross-border and multi-agency investigations, with 82% of organizations worried about being subject to such scrutiny in the coming year. At the same time, threats across cybersecurity, tax, employment, and ESG disputes remain top of mind for legal leaders.

Sunny Mann, Global Chair of Baker McKenzie, said, “We find ourselves in a paradox. Organizations are more globally connected than ever, yet operating in an increasingly fragmented and unpredictable geopolitical environment that is fundamentally altering risk calculations. 
 
The challenge for multinationals is that global integration, once seen as a hedge against risk, has become a vulnerability: supply chains cross contested borders, data flows encounter sovereignty barriers and business relationships can become compliance liabilities overnight as political alignments shift.

A primary mitigation technique among our clients is one of diversification across supply chains, customer base, funds flows, data storage and business and investment partners. Overreliance on a single party or market is a vulnerability.”

Addressing such an expansive set of risks necessitates  a delicate balancing act as organizations manage competing pressures, often with increasingly limited resources. 38% of respondents say their disputes budget for 2026 is inadequate to meet current risk levels, with funding and resourcing constraints cited as the top barrier to litigation preparedness. 

The Forecast also highlights that tax emerged as the second greatest area of concern for both disputes and investigations, likely attributed to the growing complexity of cross-border tax compliance, new international tax frameworks, and increased scrutiny from authorities, which are leading to more frequent and high-stakes tax controversies. 

Key Disputes Trends: 2026 Snapshot

According to respondents, the following types of disputes present the greatest risk to their organization in 2026 (ranked by the percentage of respondents identifying the below as their single greatest risk):

• Data privacy/cybersecurity: 18%
• Tax: 12%
• Trade sanctions/export controls: 11%
• ESG: 9%
• Employment: 8%
• Product liability and consumer disputes: 7%
• AI-related (e.g., bias, liability, misuse): 6%
• Antitrust/competition: 6%
• Commercial/contract: 6%
• Intellectual property/patents/trademark: 6%
• Brand/reputation: 6%

In 2026, organizations’ top risks for both disputes and investigations are the same— cybersecurity and tax. 

Cybersecurity and data privacy disputes (18%) and investigations (17%) are now an inescapable reality of more digitized processes and operations in the face of an ever increasing and more complex cross-border regulatory matrix and cyber-attacks that grow in sophistication almost daily.   
 
Tax emerged as both the second greatest dispute (12%) and investigations (11%) risk, reflecting the complexity of navigating cross-border tax compliance, transfer pricing scrutiny and shifting international tax frameworks. For example, notwithstanding the January 5 Side-by-Side Package, which introduced a number of favorable safe harbors, the OECD’s Pillar Two global minimum tax will continue to add a layer of tax complexity worldwide for both US and non-US parented multi-nationals. The roll out of the global minimum tax has added layers of complexity, and jurisdictions around the world are still grappling with how to balance implementing the global tax mandate into domestic law, and establishing effective and manageable reporting and compliance mechanisms. Additional concerns include developing the necessary skills to be able to administer and audit a regime that requires familiarity with the nuances of multiple accounting standards and domestic tax systems. Against this backdrop, businesses should prepare for Pillar Two disputes in all material jurisdictions. 

Trade sanctions and export controls, ESG and employment also ranked among top concerns, emphasizing that, alongside urgent pressures, organizations are addressing a diverse portfolio of risk more broadly. 

Technology, geopolitics and supply chain disruption drive external disputes risk

The rapid deployment of AI and the increasingly complex cybersecurity threats and data privacy regulations have made data-driven risk the top external driver of disputes exposure in 2026, with 80% of respondents citing it as a concern. Governments are seeking to shore up national security interests, particularly in critical infrastructure sectors such as energy, water, food, technology, health and financial services. This is prompting the creation of cyber laws that impose new reporting obligations, such as the EU’s NIS2 Directive, the US CIRCIA and Singapore’s Cybersecurity Act. These laws require critical infrastructure operators to report major cyber incidents within a stipulated time frame to protect national security and essential services.

At the same time, 79% of organizations view geopolitics and trade policy as a threat, as sanctions, tariffs and export controls disrupt global operations and create uncertainty in cross-border contracts and enforcement. Concerns over geopolitics and trade policy are felt particularly acutely in Germany (84%) and the UK (84%), reflecting the vulnerability of foreign trade-heavy economies. 

Operational and supply chain disruption, a concern for 78% of respondents, also continues to test organizational resilience.

Resource constraints expose vulnerabilities in organizations’ risk-readiness

Over one-third, 38%, of organizations report that their 2026 disputes budget is insufficient to meet current risks, which can lead to slower and less effective responses to disputes. Organizations with limited resources struggle to investigate issues thoroughly, engage specialist counsel or manage multiple cases at once. These constraints reduce flexibility and increase the risk of delayed or reactive decision-making when disputes escalate unexpectedly. Funding and resource constraints (55%) and inability to keep pace with regulatory developments (52%) have also emerged as organizations’ greatest barriers to litigation preparedness. Barriers such as addressing supply chain vulnerabilities (47%) are felt most acutely by sectors with complex and sensitive supply chains, such as industrials, manufacturing and transportation.

Cross-border investigations pose a significant threat in 2026

A remarkable 82% of respondents fear that they may be subject to a cross-border investigation in 2026, while data preservation/forensics (52%) and cross-border coordination (48%) come out as the top areas organizations say present a challenge for their preparedness for investigations. This underlines a disconnect between the looming reality of cross-border investigation risk and organizations’ ability to overcome it. Concerns over the likelihood of being subject to a cross-border investigation are felt particularly acutely by respondents in Singapore (88%) and Hong Kong (85%). This is likely due to their positions as major regional hubs for cross-border trade, financial flows and data movement, as well as a surge in whistleblowing activity in the Asia Pacific region.

Modern arbitration requires adapting to complexity

International arbitration continues to be a cornerstone of cross-border dispute resolution, valued for its flexibility, neutrality, confidentiality and enforceability across borders. In the medium term, organizations expect the greatest challenges for international arbitration to arise from digital transformation and data security, cost and duration, and geopolitical issues. Adoption and integration of technology and data security, particularly cybersecurity threats and the ethical use of AI, are expected to present challenges in areas such as virtual hearings, digital evidence management and legal research.

* * *

Baker McKenzie’s 2026 Global Disputes Forecast surveyed 600 senior decision-makers with responsibility for, or with a key role in, disputes and investigations at large organizations (annual revenue greater than USD 500 million). Respondents are based in the US, the UK, Germany, Singapore, Hong Kong and Brazil.  

With more than 1,000 battle-tested lawyers specializing in disputes and investigations, who have roots in their home jurisdictions and deep sector knowledge, Baker McKenzie’s Dispute Resolution Practice is one of the largest and most recognized in the world. Consistently top-ranked by leading market surveys, the practice supports multinational clients with their most complex and business-critical challenges across the world, particularly high-stakes multijurisdictional disputes. The Firm’s cases frequently involve novel and precedent-setting issues in countries around the world, including markets where competing law firms do not have a local presence.

 

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