On January 5, 2026 Incyte (Nasdaq:INCY) reported positive topline results from the pivotal Phase 3 frontMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi/Minjuvi), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, and lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) compared to R-CHOP alone as a first-line treatment for adults with newly diagnosed diffuse large B-cell lymphoma (DLBCL) with an International Prognostic Index (IPI) score of three to five (3-5) for patients >60 years of age, or age-adjusted IPI (aaIPI) of two to three (2-3) for patients ≤60 years of age.

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The trial met its primary endpoint of progression-free survival (PFS) by investigator assessment (Hazard Ratio 0.75 [0.59,0.96]; p-value 0.019), according to Lugano 2014 criteria. The trial also met its key secondary endpoint of event-free survival (EFS) by investigator assessment. No new safety signals were observed.

"The frontMIND study results highlight the potential benefit of combining tafasitamab and lenalidomide with R-CHOP as an effective treatment option, offering the possibility of cures for more newly diagnosed DLBCL patients," said Steven Stein, M.D., Chief Medical Officer, Incyte. "Despite improvement in treatment for patients with DLBCL, outcomes for many high-risk patients are not optimal. We look forward to working with regulatory authorities globally and to providing a new treatment option for patients in the future."

DLBCL is the most common type of non-Hodgkin lymphoma (NHL) in adults worldwide, representing 40% of all cases.1 It is characterized as an aggressive, fast-growing type of lymphoma that can emerge in lymph nodes or extranodal sites such as the gastrointestinal tract, skin and brain.2 Each year, approximately 24,000 people in the U.S. and up to 36,000 people in Europe are diagnosed with DLBCL.3,4,5,6 With about 40% of these patients not responding to initial therapy or relapsing thereafter7,8, there is a high medical need for new, effective therapies.

Based on these positive results, Incyte expects to file a supplemental Biologics License Application (sBLA) for tafasitamab for the first-line treatment of adults with newly diagnosed DLBCL in the first half of 2026. The frontMIND data will be submitted for presentation at an upcoming scientific meeting.

Tafasitamab was approved in combination with lenalidomide by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2020 and 2021 respectively, for adult patients with relapsed or refractory DLBCL not otherwise specified including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant. Additionally, tafasitamab was approved in combination with lenalidomide and rituximab by the FDA in June 2025 for adult patients with relapsed or refractory follicular lymphoma (FL). In November 2025, the EMA’s Committee for Medicinal Products for Human Use issued a positive opinion recommending the approval of tafasitamab for patients with relapsed or refractory FL.

About frontMIND

The frontMIND trial (NCT04824092) is a randomized, double-blind, placebo-controlled, global Phase 3 study in patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

The study has enrolled approximately 900 adults (≥18 to ≤80 years) and is evaluating the efficacy and safety of tafasitamab and lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) compared with R-CHOP alone.

The primary endpoint of the study is investigator-assessed progression-free survival (PFS) using the Lugano 2014 criteria. Key secondary endpoints include event-free survival (EFS) by investigator assessment and overall survival (OS).

For more information about the frontMIND trial, please visit View Source

About Tafasitamab (Monjuvi/Minjuvi)

Tafasitamab (Monjuvi/Minjuvi) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

In Europe, Minjuvi (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.

XmAb is a registered trademark of Xencor, Inc.

Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the "triangle" design are registered trademarks of Incyte.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of MONJUVI?

MONJUVI may cause serious side effects, including:

Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
Infections. Serious infections, including infections that can cause death, have happened in people during treatment with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection.
The most common side effects of MONJUVI include:

Feeling tired or weak
Diarrhea
Cough
Fever
Swelling of lower legs or hands
Respiratory tract infection
Decreased appetite
These are not all the possible side effects of MONJUVI. Your healthcare provider will give you medicines before each infusion to decrease your chance of infusion reactions. If you do not have any reactions, your healthcare provider may decide that you do not need these medicines with later infusions. Your healthcare provider may need to delay or completely stop treatment with MONJUVI if you have severe side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all of your medical conditions, including if you:

Have an active infection or have had one recently.
Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.
You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

(Press release, Incyte, JAN 5, 2026, View Source [SID1234661735])

On January 4, 2026 Insilico Medicine ("Insilico"), a world-leading artificial intelligence (AI)-driven drug discovery company, reported a multi-year research and development (R&D) collaboration with Servier, an independent international pharmaceutical company governed by a foundation. This strategic alliance is focused on identifying and developing novel therapeutics for challenging targets in the oncology space by leveraging Insilico’s proprietary AI platform, Pharma.AI.

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Under the agreement, Insilico will be eligible to receive up to US$32 million in upfront and near-term R&D payments and will lead the AI-driven discovery and development of potential drug candidates that meet predefined criteria, while Servier will share the R&D expenses and lead clinical validation and commercialization processes.

"This collaboration underscores Servier’s commitment to applying cutting-edge technologies to address unmet medical needs for the benefit of patients and reflects our confidence in Insilico’s internally developed and validated AI platform", said Christophe Thurieau, Executive Director Research at Servier.

"I am excited to see the collaboration—it is yet another strong acknowledgment of our AI capabilities and R&D expertise", said Alex Zhavoronkov, PhD, founder, CEO and CBO of Insilico Medicine. "As we deepen the integration of generative AI into every stage of the pharma value chain, I believe the future of pharmaceutical superintelligence is never so close, where AI agents could actually make decisions and design experiments, driving a virtuous cycle of faster, smarter, and safer drug development."

Insilico has extensive experience in AI-driven oncology drug discovery and development. The company has established a robust oncology pipeline that targets multiple cancer indications, leveraging both moderately novel and well-established mechanisms. Among its most promising assets, the potential best-in-class pan-TEAD inhibitor ISM6331 and the MAT2A inhibitor ISM3412 are both undergoing global, multicenter Phase I clinical trials. Additionally, four other oncology programs have been fully or partially out-licensed to partners, with Phase I clinical trials actively in progress.

Harnessing state-of-the-art AI and automation technologies, Insilico has significantly improved the efficiency of preclinical drug development, setting a benchmark for AI-driven drug R&D. While traditional early-stage drug discovery typically requires an average of 4.5 years, Insilico has nominated 20 preclinical candidates from 2021 to 2024, with an average timeline—from project initiation to preclinical candidate (PCC) nomination—of just 12 to 18 months per program, with only 60 to 200 molecules synthesized and tested in each program.

(Press release, Insilico Medicine, JAN 4, 2026, View Source [SID1234661696])

On January 2, 2026 Hoth Therapeutics (NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing innovative therapies for underserved medical needs, reported the filing of two U.S. provisional patent applications that significantly expand the Company’s intellectual property portfolio and establish a new oncology-focused dermatology platform targeting treatment-induced skin toxicity from modern cancer therapies.

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The first provisional patent application, titled covering the topical treatment of radiation-induced skin toxicity in oncology patients.

The second provisional patent application, titled addressing dermatologic toxicities associated with emerging targeted cancer therapies, including second and third menin inhibitors.

Together, these dual filings secure priority intellectual property rights around the use of HT-001 to treat dermatologic toxicities across multiple oncology treatment modalities, including radiation therapy and next-generation targeted agents. As cancer treatments become more effective and patients remain on therapy longer, managing treatment-limiting skin toxicities has become a critical and growing unmet need in oncology care.

Radiotherapy-induced dermatitis and dermatologic adverse effects from targeted oncology therapies frequently result in pain, inflammation, severe pruritus, infection risk, reduced quality of life, and treatment interruption or discontinuation, which can negatively impact patient outcomes. Despite their prevalence, current treatment options remain largely supportive, with few mechanism-driven therapies designed to address the underlying biological drivers of these conditions.

Hoth’s patent filings seek to protect the use of HT-001, a receptor antagonist with a well-established pharmacologic profile, to target neurogenic and inflammatory pathways implicated in therapy-induced skin injury. The Company believes this approach may represent a novel and potentially first-in-class strategy within the rapidly expanding oncology supportive-care and oncodermatology markets.

"These filings represent a meaningful expansion of our intellectual property estate into an increasingly important area of oncology care," said Robb Knie of Hoth Therapeutics. "As cancer therapies advance, the ability to manage treatment-related toxicities is becoming essential. We believe this emerging platform highlights our strategy of identifying differentiated, mechanism-driven opportunities that can address significant unmet needs while creating long-term shareholder value."

The Company believes these provisional patents support the development of a scalable oncology-adjacent platform with potential applications across radiation oncology, targeted cancer therapies, dermatology, and inflammatory skin disorders, while leveraging an established compound in novel therapeutic contexts, formulations, and routes of administration. The filings also provide flexibility to pursue additional preclinical development, formulation optimization, and future U.S. and international patent protection.

Hoth Therapeutics continues to execute its strategy of building a diversified, IP-centric development portfolio focused on large, underserved markets, with an emphasis on therapies designed to improve patient outcomes and quality of life.

(Press release, Hoth Therapeutics, JAN 2, 2026, View Source [SID1234661689])

On January 2, 2026 Lantheus Holdings, Inc. ("Lantheus" or the "Company") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company dedicated to helping clinicians Find, Fight, and Follow disease to deliver better patient outcomes, reported it has completed the previously announced sale of its single photon emission computed tomography (SPECT) business to SHINE Technologies, LLC, a subsidiary of Illuminated Holdings, Inc. (collectively, "SHINE"). Under the terms of the agreement, SHINE has acquired Lantheus’ SPECT business, including its diagnostic agents (TechneLite (Technetium Tc 99m generator), NEUROLITE (Kit for the Preparation of Technetium Tc 99m Bicisate for Injection), Xenon Xe-133 Gas (Xenon Xe-133 Gas), and Cardiolite (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection)), the portion of the North Billerica, Massachusetts campus that manufactures Lantheus’ SPECT products, and the SPECT-related Canadian operations.

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With the SPECT divestiture finalized, Lantheus will focus on its growing commercial portfolio of innovative PET radiodiagnostics and microbubbles, while also advancing its pipeline of radiopharmaceuticals.

Advisors
Solomon Partners Securities, LLC acted as financial advisor to Lantheus in this transaction, while Foley Hoag LLP and Ropes & Gray LLP acted as legal advisors, and Ernst & Young LLP acted as financial and tax advisor.

TechneLite (Technetium Tc 99m generator)

INDICATIONS AND USAGE:

The TechneLite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits.

Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for:

Thyroid Imaging
Salivary Gland Imaging
Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.
Nasolacrimal Drainage System Imaging
Sodium Pertechnetate Tc 99m Injection is used IN CHILDREN as an agent for:

Thyroid Imaging
Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.
IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS:

None known.

IMPORTANT SAFETY INFORMATION:

Allergic reactions including anaphylaxis have been reported infrequently following the administration of Sodium Pertechnetate Tc 99m Injection.

WARNINGS

Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy.
These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.

PRECAUTIONS

Since the eluate does not contain an antimicrobial agent, it should not be used after 12 hours from the time of TechneLite, Technetium Tc 99m Generator, elution. After the termination of the nasolacrimal imaging procedure, blowing the nose and washing the eyes with sterile distilled water or an isotonic sodium chloride solution will further minimize the radiation dose. As in the use of any radioactive material, care should be taken to minimize radiation exposure to patients and occupational workers. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience and who are licensed in the safe handling of radionuclides.

Please see full Prescribing Information.

Xenon (Xenon Xe-133 Gas)

INDICATIONS AND USAGE

Inhalation of Xenon Xe-133 Gas has proved valuable for the evaluation of pulmonary function and for imaging the lungs. It may also be applied to assessment of cerebral flow.

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS

None known.

Adverse reactions related to the use of this agent have not been reported to date.

WARNINGS

Xenon Xe-133 Gas delivery systems, i.e., respirators or spirometers, and associated tubing assemblies must be leak-proof to avoid loss of radioactivity into environs not specifically protected by exhaust systems.

Xenon Xe-133 adheres to some plastics and rubber and should not be allowed in tubing or respirator containers. The unrecognized loss of radioactivity from the dose for administration may render the study non-diagnostic.

The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex.

PRECAUTIONS

General

Xenon Xe-133, as well as other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to patients and to clinical personnel.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Please see full Prescribing Information.

NEUROLITE (Kit for the Preparation of Technetium Tc 99m Bicisate for Injection)

INDICATIONS

NEUROLITE single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed.

NEUROLITE is not indicated for assessment of functional viability of brain tissue or for distinguishing between stroke and other brain lesions.

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS

None known.

In clinical trials, NEUROLITE has been administered to 1063 subjects (255 normals, 808 patients). In the 808 patients with neurologic events, there were 11 (1.4%) deaths, none of which were clearly attributed to NEUROLITE.

The following adverse effects were observed in ≤ 1% of the subjects: headache, dizziness, seizure, agitation/anxiety, malaise/somnolence, parosmia, hallucinations, rash, nausea, syncope, cardiac failure, hypertension, angina, and apnea/cyanosis.

WARNINGS

None known.

PRECAUTIONS

General
USE WITH CAUTION IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT. TECHNETIUM Tc99m BICISATE IS ELIMINATED PRIMARILY BY RENAL EXCRETION. WHETHER TECHNETIUM Tc99m BICISATE IS DIALYZABLE IS NOT KNOWN. DOSE ADJUSTMENTS IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT HAVE NOT BEEN STUDIED.

Patients should be encouraged to drink fluids and to void frequently during the 2-6 hours immediately after injection to minimize radiation dose to the bladder and other target organs.

As with any other radioactive material, appropriate shielding should be used to avoid unnecessary radiation exposure to the patient, occupational workers, and other people.

Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides.

Please see full Prescribing Information.

Cardiolite (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection)

INDICATIONS AND USAGE

Myocardial Imaging: Cardiolite (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Cardiolite evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g. exercise or pharmacologic stress in accordance with the pharmacologic stress agent’s labeling).

It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia.

Breast Imaging: MIRALUMA, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass.

MIRALUMA is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS

None known.

Cardiolite has been rarely associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria. In some patients the allergic symptoms developed on the second injection during Cardiolite imaging. The most frequently reported adverse events include headache, chest pain/angina, ST segment changes on ECG, nausea, and abnormal taste and smell.

Infrequently, death has occurred 4 to 24 hours after Tc99m Sestamibi use and is usually associated with exercise stress testing (See Section 5.2). Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events.

WARNINGS AND PRECAUTIONS

In studying patients in whom cardiac disease is known or suspected, care should be taken to assure continuous monitoring and treatment in accordance with safe, accepted clinical procedure.

Caution should be exercised and emergency equipment should be available when administering Cardiolite.

Before administering Cardiolite patients should be asked about the possibility of allergic reactions to either Cardiolite or Miraluma. Miraluma is an identical compound used in breast imaging.

The contents of the vial are intended only for use in the preparation of Technetium Tc99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure.

(Press release, Lantheus, JAN 2, 2026, View Source [SID1234662965])

On January 2, 2026 Boston Scientific Corporation (NYSE: BSX) reported it will participate in the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13th, 2026, in San Francisco. Mike Mahoney, chairman and chief executive officer, Jon Monson, executive vice president and chief financial officer, and Ken Stein, M.D., senior vice president and global chief medical officer, will participate in a 40-minute question-and-answer session with the host analyst. The session will begin at approximately 9:00 a.m. PT / 12:00 p.m. ET.

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Additionally, the company will webcast its conference call discussing financial results and business highlights for the fourth quarter and full year ended December 31, 2025, on Wednesday, February 4, 2026, at 8:00 a.m. ET. The call will be hosted by Mike Mahoney and Jon Monson. The company will issue a news release announcing financial results for the fourth quarter and full year 2025 on February 4 prior to the conference call.

A live webcast and replay for each event will be accessible at View Source The replay will be available approximately one hour following the completion of the event.

(Press release, Boston Scientific, JAN 2, 2026, View Source [SID1234661684])