Boston Scientific announces results for first quarter 2026

On April 22, 2026 Boston Scientific Corporation reported net sales of $5.203 billion during the first quarter of 2026, growing 11.6 percent on a reported basis and 9.4 percent on an operational1 and organic2 basis, all compared to the prior year period. The company reported GAAP net income attributable to Boston Scientific common stockholders of $1.341 billion or $0.90 per share (EPS), compared to $674 million or $0.45 per share a year ago, and achieved adjusted3 EPS of $0.80 for the period, compared to $0.75 a year ago.

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"Our global team and the strength of our category leadership strategy enabled us to deliver solid results this quarter," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We remain focused on executing our long-term strategy and advancing our differentiated pipeline to drive meaningful impact for patients, physicians and hospital systems."

First quarter financial results and recent developments:

Reported net sales of $5.203 billion, representing an increase of 11.6 percent on a reported basis, compared to the company’s guidance range of 10.5 to 12.0 percent; and 9.4 percent on an operational and organic basis, compared to the company’s guidance range of 8.5 to 10.0 percent, all compared to the prior year period.
Reported GAAP net income attributable to Boston Scientific common stockholders of $0.90 per share, and achieved adjusted EPS of $0.80 per share, compared to the guidance range of $0.78 to $0.80 per share.
Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 7.8 percent reported, 5.7 percent operational and organic
Cardiovascular: 13.5 percent reported, 11.2 percent operational and organic
Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 10.9 percent reported and operational
Europe, Middle East and Africa (EMEA): 10.1 percent reported and 1.2 percent operational
Asia-Pacific (APAC): 14.7 percent reported and 12.0 percent operational
Latin America and Canada (LACA): 19.0 percent reported and 12.0 percent operational
Announced clinical trial results that were presented in late-breaking sessions at the 75th Annual Scientific Session of the American College of Cardiology and simultaneously published in The New England Journal of Medicine including:
The CHAMPION-AF study of the WATCHMAN FLX Left Atrial Appendage Closure Device as a first-line option for stroke risk reduction, which met all primary and secondary endpoints and demonstrated superior bleeding risk reduction and similar efficacy of the WATCHMAN FLX device compared to oral anticoagulants in a broad population of patients with non-valvular atrial fibrillation (AF).
The HI-PEITHO clinical trial evaluating the EKOS Endovascular System for the treatment of acute pulmonary embolism (PE) in patients with intermediate-risk PE, which demonstrated the EKOS system plus anticoagulation was superior to anticoagulation alone.
Announced positive outcomes from the ADVENT Long-Term Outcomes clinical trial, which demonstrated greater long-term AF treatment success, fewer hospital-based arrhythmia interventions and lower repeat ablation rates at four years with FARAPULSE Pulsed Field Ablation (PFA) compared to thermal ablation.
Received National Medical Products Association approval in China for the OPAL HDx Mapping System, which enables catheter visualization during FARAPULSE PFA procedures.
Published in Chronic Pain and Management Journal outcomes from the 24-month COMFORT clinical trial demonstrating durable and statistically significant pain relief and improved quality of life with peripheral nerve stimulation therapy with the Nalu Neurostimulation System compared to conventional medical management in patients with chronic pain.
Received U.S. Food and Drug Administration 510(k) clearance for the Asurys Fluid Management System, designed to provide real-time irrigation management during endoscopic urologic procedures; when used with the LithoVue Elite Single-Use Flexible Ureteroscope System, it also supports intrarenal pressure (IRP) management during ureteroscopy.
Completed the acquisition of Valencia Technologies Corporation, a privately held company focused on the development and commercialization of the eCoin System, an implantable tibial nerve stimulation device for the treatment of urge urinary incontinence.
Elected to the company’s board of directors Cathy Smith, chief financial officer of Starbucks, and Christophe Weber, president and chief executive officer of Takeda Pharmaceutical.

(Press release, Boston Scientific, APR 22, 2026, View Source [SID1234669158])

Immutep Announces Abstract Accepted for Presentation at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting

On April 22, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage immunotherapy company targeting cancer and autoimmune diseases, reported an abstract has been selected for poster presentation at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in-person and online from 29 May-2 June 2026 in Chicago, Illinois (United States).

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The accepted abstract, titled "Impact of eftilagimod alfa, an APC activator via MHC class II, on lymphocyte activation and survival outcomes in metastatic cancer patients," will be presented within the Developmental Therapeutics—Immunotherapy sessions by Professor Martin Forster from the UCL Cancer Institute, UK.

The poster will present cumulative clinical and translational data demonstrating that eftilagimod alfa (efti), an antigen-presenting cell (APC) activator targeting MHC Class II, induces rapid and sustained lymphocyte activation. Across multiple late-stage cancer studies1, immune activation markers were associated with improved overall survival outcomes in patients with metastatic disease, supporting the clinical relevance of eftilagimod alfa’s mechanism of action.

ASCO 2026 Poster Presentation Details

Title: Impact of eftilagimod alfa, an APC activator via MHC class II, on lymphocyte activation and survival outcomes in metastatic cancer patients
Poster Session: Developmental Therapeutics—Immunotherapy
Date and Time: 30 May 2026, 1:30 PM-4:30 PM CDT
Poster Board: 359
Abstract #: 2569

About ASCO (Free ASCO Whitepaper) 2026

The ASCO (Free ASCO Whitepaper) Annual Meeting represents the world’s largest gathering of oncology physicians, industry representatives, researchers, patient advocates and investment analysts to discuss cutting-edge clinical research and emerging therapeutics in oncology, and to gain insights to improve cancer care. More than 40,000 attendees from around the world are expected to participate in person and online to stay up to date on the latest advances across all areas of cancer research and to hear real-time insights from world-renowned experts. For additional information on the ASCO (Free ASCO Whitepaper) Annual Meeting, please visit www.asco.org.

(Press release, Immutep, APR 22, 2026, View Source [SID1234664625])

RedHill’s Opaganib Enhances Efficacy of Neuroblastoma Chemo Combination and Augment Anti-Tumor Immunity in Triple-Negative Breast Cancer in Preclinical Studies – New Data Presented at AACR 2026

On April 22, 2026 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported the independent presentation of new preclinical data at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, showing positive effects of opaganib as potential add-on therapy in models of neuroblastoma (NB) and triple-negative breast cancer (TNBC).

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The positive NB data, from studies undertaken by Penn State University’s Jeremy Hengst, PhD, and Apogee Biotechnology funded by the Beat Childhood Cancer Foundation and Four Diamonds, indicate that opaganib may enhance the therapeutic efficacy of the oxaliplatin + doxorubicin (OXDOX) chemotherapy combination in high-risk NB. The data showed that opaganib directly destabilized n-Myc, a key oncogenic driver of neuroblastoma and other solid tumors, regulating cell proliferation, differentiation, and apoptosis during embryonic development, a critical factor driving poor outcomes.

A second poster from the University of Kansas’ Colette Worcester describes in vitro model data showing that pre-treatment with opaganib, followed by low-dose diABZI treatment, potentiated the downstream STING-mediated effects and may augment anti-tumor immunity in TNBC, which has the poorest prognosis of the breast cancer subtypes.

Dr. Mark Levitt, Chief Scientific Officer at RedHill said: "These data represent exciting findings that could hold promise for improving outcomes in treating pediatric NB and TNBC, providing additional encouragement for further exploration. Opaganib has previously shown potential as add-on therapy in several preclinical oncology models in combination with chemotherapy. Moreover, the ongoing Phase 2 clinical study of opaganib in combination with darolutamide in advanced prostate cancer could potentially provide paradigm-shifting clinical data in support of the additive use of opaganib in a cancer setting."

Neuroblastoma is the most common infancy cancer with ~5,500 global pediatric cases per year in children aged 0–14. It accounts for 10% of childhood cancers and 15% of pediatric cancer-related deaths in the U.S.5,6 Opaganib received FDA Orphan Drug and Rare Pediatric Disease designations for the treatment of neuroblastoma, a rare pediatric cancer, with potential for a Rare Pediatric Disease Priority Review Voucher ("PRV"). Development discussions for this indication are ongoing with Penn State University and the Beat Childhood Cancer consortium.

About Opaganib (ABC294640)

Opaganib is a proprietary first-in-class investigational, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor drug. Potentially broad-acting, it is in development for multiple oncology, viral, inflammatory, metabolic (diabetes and obesity) and additional indications.

Peer-reviewed data, published in the journal Diabetes, Metabolic Syndrome and Obesity7, provides evidence that opaganib uniquely works through the inhibition of multiple pathways implicated in insulin resistance, β-cell disruption, adipocyte function, inflammation / immune regulation, vascular complications, energy metabolism, induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).

Opaganib has received Orphan Drug designation from the FDA for the treatment of neuroblastoma and cholangiocarcinoma. A Bayer-supported 80-patient placebo-controlled randomized Phase 2 study is ongoing to evaluate the efficacy of opaganib in combination with Bayer’s darolutamide in men with metastatic castrate-resistant prostate cancer (mCRPC), testing the potentially enhancing effect of opaganib in patients with a poor prognosis8. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.

Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use, including a large global Phase 2/3 study in hospitalized patients with moderate to severe COVID-19, published in Microorganisms.

(Press release, RedHill Biopharma, APR 22, 2026, View Source [SID1234664690])

Flatiron Health Announces 18 Research Acceptances Featuring Flatiron’s Real-World Data to Be Presented at ISPOR 2026

On April 22, 2026 Flatiron Health reported its presence at the ISPOR—The Professional Society for Health Economics and Outcomes Research Annual Meeting happening from May 17-20, 2026, in Philadelphia, Pennsylvania. Flatiron’s high-quality real-world data and innovative research capabilities are featured across 18+ research acceptances, including seven Flatiron authored research posters as well as a panel presentation "Beyond Black Boxes: Transparent, Validated LLM Workflows for Accelerating Global HTA Submissions and Decisions."

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Flatiron’s presence at ISPOR 2026 closely follows the publication of the Validation of Accuracy for LLM/ML-Extracted Information and Data (VALID) Framework in the Journal of Clinical Oncology Clinical Cancer Informatics.The framework represents the first and most comprehensive, peer-reviewed approach to evaluating the quality and reliability of real-world data extracted by large language models and machine learning—establishing new industry standards for data integrity in oncology research.

"The rapid advancements of large language models and AI-enabled tools have required an incredibly thoughtful approach to data validation and research methodologies," said Emily Castellanos, MD, MPH, Senior Medical Director and Head of Research Oncology at Flatiron Health. "Flatiron’s presence at ISPOR reflects our commitment to advancing the field with high-fidelity, decision-ready real world evidence, reinforcing our position as the gold standard in oncology intelligence and a trusted partner for high-stakes clinical and research decisions."

Research highlights include:

Research assessing an LLM-approach that integrates PSA and imaging data to derive real-world progression events in prostate cancer with accuracy and completeness
A study building and evaluating four different digital-twin modeling approaches to predict survival in patients with advanced non-small cell lung cancer
An application of the newly published VALID framework to assess quality of an LLM-derived prostate cancer real-world dataset
A collaborative pilot project led by Friends of Cancer Research that demonstrated success of real-world data supported external-control arms depends on the quality of data, consistent methodology, and attentive planning.
Join Flatiron Health at booth #316 Follow Flatiron Health on X and LinkedIn for more updates from #ISPORAnnual.

Speaking Sessions

Beyond Black Boxes: Transparent, Validated LLM Workflows for Accelerating Global HTA Submissions and Decisions
Moderator: Beth Devine
Speakers: Bill Malcolm, Tim Reason, Lockwood Taylor
Speaking Session Date/Time: Wednesday, May 20, 10:00–11:00 AM ET

Abstracts and Poster Presentations

Assessing quality of a LLM-derived prostate cancer (PC) real-world dataset: an application of the validation of accuracy for LLM/ML-extracted information and data (VALID) framework
Patrick J. Ward, Yunzhi Qian, Eunice A. Hankinson, Aaron Dolor, Melissa Estevez
Poster Session: Poster Session 2
Poster Code: MSR65
Poster Session Date/Time: Monday, May 18, 4:00 PM – 7:00 PM

Real-world treatment patterns and outcomes in patients with =2 lines of therapy for recurrent or progressive endometrial cancer
Rachel Bhak, Neeraj N. Iyer, Audrey Hopkins, Murat M. Ikiisik, Edward Kavalerchik, Mala Talekar, Xinye Li, Nada Boualam, Prakirthi Yerram, Fernanda Musa
Author affiliations: Genmab, Providence-Swedish Cancer Institute, Flatiron Health
Poster Session: 2
Poster Code: HSD38
Poster Session Date/Time: Monday, May 18, 4:00 PM – 7:00 PM

Impact of telemedicine encounters on survival outcomes: A time-varying cox analysis using EHR-derived data
Deepika Paratane, Blythe Adamson, Antal T. Zemplenyi
Author affiliations: University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Flatiron Health
Poster Session: 3
Poster Code: HSD60
Poster Session Date/Time: Monday, May 18, 10:30 – 1:30 PM

Customization of a large language model approach to capture PSA and imaging derived real-world progression events in prostate cancer
Kelly Magee, Patrick Ward, PhD, Wanjing Chen, Eunice Hankinson, Aaron Dolor
Poster Session: Poster Session 4
Poster Code: RWD123
Poster Session Date/Time: Tuesday, May 19, 4:00 PM – 7:00 PM

Evaluating model performance for between-country survival transportability
Mohamed S. Ali, Harlan Pittell, Elsie Horne, Philani Mpofu, Qianyi Zhang, Blythe Adamson
Poster Session: Poster Session 4
Poster Code: MSR169
Poster Session Date/Time: Tuesday, May 19, 4:00 PM – 7:00 PM

From real-world data (RWD) to digital twins: Building models for patient-level counterfactual prediction in oncology
Sandra Griffith, Joe Manfredonia, Marcello Ricottone, Richard Knoche, Aaron B. Cohen, Jacqueline Law, Melissa Estevez
Poster Session: Poster Session 5
Poster Code: MSR219
Poster Session Date/Time: Wednesday, May 20, 9:00 AM – 11:30 AM

External control arm feasibility across external data sources in oncology: Methodological and regulatory considerations
Bernat Navarro, Kawther Abdilleh, Amy Alabaster, Peter Ansell, Li Chen, Gregory S. Calip, Ruthanna Davi, Janet Espirito, Laura L. Fernandes, Sebastian Zavala Hoffmann, Patricia Luhn, Xinran Ma, Patricia Prince, Mark Riffon, Xiang Yin, Mark Stewart, Hillary Andrews, Jeff Allen
Author Affiliations: Friends of Cancer Research, Pancreatic Cancer Action Network, ConcertAI, AbbVie, Amgen, Medidata, Ontada, COTA Healthcare, iOMEDICO, Genentech, Flatiron Health, Aetion/Datavant, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)
Poster Session: Poster Session 5
Poster Code: RWD154
Poster Session Date/Time: Wednesday, May 20, 9:00 AM – 11:30 AM

(Press release, Flatiron Health, APR 22, 2026, View Source [SID1234664706])

Tempest Announces Key Manufacturing Milestone for TPST-2003 Dual-Targeting CD19/BCMA CAR-T

On April 22, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company developing a pipeline of advanced CAR-T cell therapy product candidates to treat cancer, reported that it has achieved a key milestone in the development of TPST-2003, Tempest’s dual-targeting CD19/BCMA CAR-T therapy under development for the treatment of relapsed/refractory multiple myeloma ("rrMM"). Earlier this month, Tempest’s manufacturing partner, Cincinnati Children’s Applied Gene and Cell Therapy Center ("AGCTC"), took delivery of the TPST-2003 lentiviral vector, a critical component used in the manufacturing of TPST-2003. This milestone supports Tempest’s plans to initiate the first potentially registrational study to evaluate a dual-targeting CAR-T therapy in patients with rrMM, including patients who are experiencing extramedullary disease ("EMD"), later this year.

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Tempest recently announced that, as of a January 31, 2026 data cutoff, a total of 36 patients with rrMM had received one infusion of TPST-2003, including 24 patients in a prior Phase 1/2 investigator-initiated trial ("IIT") and 12 patients in the ongoing REDEEM-1 trial, representing one of the largest datasets evaluating a CD19/BCMA dual-targeting CAR-T therapy. As of the data cutoff, all six efficacy evaluable patients enrolled in the REDEEM-1 trial had achieved a complete response according to the International Myeloma Working Group uniform response criteria. Among 25 evaluable patients with measurable disease at baseline across both studies, the overall response rate was 100% (25/25). The IIT also demonstrated durable disease control, with median progression-free survival ("PFS") of 23.1 months across all patients and median PFS of 23.1 months in patients with EMD. Tempest plans to present the results of the REDEEM-1 trial and updated results from the IIT at a scientific meeting later this year.

"We are pleased by the rapid progress we have been making in partnership with AGCTC," said Dr. Matt Angel, President and Chief Executive Officer of Tempest. "The delivery of lentiviral vector, which is a critical component in the manufacturing of autologous CAR-T products, has enabled us to proceed with the manufacturing activities required for the pivotal development of TPST-2003. We are grateful for our partnership with AGCTC, and we are looking forward to continued rapid progress toward the initiation of a potentially registrational study for TPST-2003 later this year."

AGCTC is a research, development, and manufacturing hub advancing future cell and gene therapy (CGT) treatments for patients with unmet needs. Established in 2001, the center has evolved into a nationally recognized leader in CTG CDMO services with a proven track record that reflects Cincinnati Children’s commitment to solving unmet medical needs through translational science. AGCTC is part of the Cincinnati Children’s Cancer and Blood Diseases Institute, which is ranked #1 in the nation by U.S. News & World Report for pediatric cancer care.

"We are excited to have achieved this important milestone in the development of TPST-2003," said Dr. Chaozhong Zou, Executive Director and General Manager of AGCTC, Cancer and Blood Diseases Institute, Cincinnati Children’s Hospital Medical Center. "The clinical data generated so far support the idea that the parallel-structure dual-targeting CAR architecture of TPST-2003 could offer patients with rrMM a meaningful new treatment option, and we are grateful to be in position to support the development of TPST-2003 by leveraging our extensive experience making novel CAR-T programs IND-ready. We look forward to generating the information needed to support the pivotal development of TPST-2003."

About TPST-2003

TPST-2003 is an autologous CD19/BCMA dual-targeting CAR-T therapy designed to improve response depth and durability in patients with relapsed/refractory multiple myeloma ("rrMM") through a parallel dual-targeting CAR structure designed to address tumor heterogeneity and antigen escape. TPST-2003 is being developed in China by Tempest’s partner, Novatim Immune Therapeutics ("Novatim"). Under its agreement with Novatim, Tempest has the exclusive right to develop TPST-2003 outside of China, India, Turkey, and Russia.

About REDEEM-1

REDEEM-1 (Study nos. CTR20233309/NCT06223646) is a Phase 1/2a clinical trial evaluating TPST-2003 in patients with relapsed/refractory multiple myeloma, including patients with high-risk cytogenetics and patients with extramedullary disease. The REDEEM-1 trial has a targeted full enrollment of 29 patients. The REDEEM-1 trial is sponsored and being conducted by Tempest’s partner, Novatim Immune Therapeutics, with a total of eight clinical sites registered in China: Peking Union Medical College Hospital (Dr. Jian Li; lead site), The First Affiliated Hospital of Nanchang University (Dr. Fei Li), Peking University First Hospital (Dr. Yujin Dong), Henan Cancer Hospital (Dr. Baijun Fang), Shanxi Provincial Cancer Hospital (Dr. Liping Su), The Second Xiangya Hospital of Central South University (Dr. Hongling Peng), The First Affiliated Hospital of China Medical University (Dr. Xiaojing Yan), and The Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College (Dr. Dehui Zou).

Additional clinical trials evaluating TPST-2003

A Phase 1/2 IIT (Study no. NCT04714827) is evaluating TPST-2003 in patients with relapsed/refractory multiple myeloma, including patients with high-risk cytogenetics and patients with extramedullary disease. The IIT is sponsored and being conducted by Tempest’s partner, Novatim, with a total of two clinical sites registered in China: Shanghai Fourth People’s Hospital (Dr. Weijun Fu; lead site) and Shanxi Provincial Cancer Hospital (Dr. Liping Su).

A Phase 1 trial (Study nos. CTR20242409/NCT06518876) is evaluating TPST-2003 in patients with POEMS, a rare blood disorder caused by abnormal plasma cells. The Phase 1 trial is sponsored and being conducted by Tempest’s partner, Novatim, with a total of three clinical sites registered in China: Peking Union Medical College Hospital (Dr. Jian Li; lead site), Xuanwu Hospital Capital Medical University (Dr. Wanling Sun), and West China Hospital, Sichuan University (Dr. Yu Wu).

(Press release, Tempest Therapeutics, APR 22, 2026, View Source [SID1234664691])