BeOne Medicines’ BEQALZI™ (sonrotoclax) Approved by U.S. FDA as First and Only BCL2 Inhibitor for R/R Mantle Cell Lymphoma

SAN CARLOS, Calif. - Thursday, 14. May 2026

BEQALZI is a foundational BCL2 inhibitor designed for greater potency and selectivity, with potential to improve efficacy, tolerability, and convenience versus others in the class

Approval of BEQALZI marks the first new BCL2 inhibitor approved in a decade in the U.S. and the only BCL2 inhibitor approved in MCL, aiming to set a new standard of innovation

 

(BUSINESS WIRE)--BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BEQALZI™ (bee-KAHL-zee; sonrotoclax), a foundational, next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. BEQALZI was designed to enhance BCL2 inhibition—with greater potency, selectivity, and a pharmacologic profile with potential to improve efficacy, tolerability, and convenience over others in the class.

Michael Wang, M.D., Global Principal Investigator, the Puddin Clarke Endowed Professor, Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, said:

“The data supporting the approval of sonrotoclax in the U.S. confirm its role as a foundational therapy for mantle cell lymphoma in the post-BTK inhibitor setting, and demonstrate that it can deliver robust disease control when treatment choices are limited and outcomes are poor. From a clinical perspective, this provides physicians with an important new option grounded in both efficacy and tolerability, fundamentally changing how we think about sequencing therapy in this disease.”

Data supporting approval

The accelerated approval of BEQALZI is supported by efficacy and safety data from the Phase 1/2 study, BGB-11417-201 (NCT05471843), which was presented at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition. The study included an independent review of efficacy data and demonstrated:

    Overall response rate (ORR): 52% (95% CI, 42-62)
    Complete response (CR) rate: 16% (95% CI, 9.1-24.0)
    Median time to response (TTR): 1.9 months
    Median duration of response (DOR): 15.8 months (95% CI, 7.4 months-NE) at a median response follow-up of 11.9 months (has yet to reach full maturity)
    Safety: treatment with sonrotoclax monotherapy was generally well tolerated

Continued approval for this indication is contingent upon confirmation of clinical benefit in the confirmatory CELESTIAL-RRMCL trial (NCT06742996), which is underway. The U.S. FDA granted Breakthrough Therapy Designation (BTD) for sonrotoclax in this indication, as well as Fast Track Designation and Orphan Drug Designation.

Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said:

“BeOne is leading the advancement and enhancement of BCL2 inhibition to revolutionize how we treat patients living with B-cell malignancies. Today’s approval of BEQALZI represents critical progress for patients with mantle cell lymphoma and reinforces our strategy of building foundational medicines designed to raise the standard of care in B-cell malignancies.”

A new BCL2 option for a challenging R/R MCL post–BTK inhibitor setting

MCL is a rare and often aggressive subtype of non-Hodgkin lymphoma. In the United States, approximately 3,300 new cases of MCL are diagnosed each year.1 While many patients respond to initial therapy, relapse is common, and outcomes after progression can be poor, particularly after prior treatment with a BTK inhibitor. The accelerated approval of BEQALZI introduces a new targeted mechanism to the MCL treatment landscape and reinforces the importance of expanding therapeutic choices for patients as the disease evolves.

Meghan Gutierrez, Chief Executive Officer, Lymphoma Research Foundation, said:

“For people living with relapsed or refractory mantle cell lymphoma, each progression can bring uncertainty and questions regarding remaining treatment options. The FDA approval of sonrotoclax represents significant progress for the U.S. mantle cell lymphoma community, offering renewed hope for patients and families who have exhausted other available therapies. Advances like this underscore why continued research and innovation in this disease remain so critical.”

Additional regulatory and development updates

BEQALZI is also approved in China for the treatment of R/R MCL, as well as adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have previously received at least one systemic therapy, including a BTK inhibitor. Data from the Phase 1/2 study of sonrotoclax in R/R MCL is also under review by the European Medicines Agency and other regulatory agencies.

The U.S. FDA also granted sonrotoclax Fast Track Designation for Waldenström macroglobulinemia (WM), as well as Orphan Drug Designation for the treatment of adult patients with WM, multiple myeloma, acute myeloid leukemia, and myelodysplastic syndrome.

Additionally, sonrotoclax is currently being studied in combination with other therapeutics, including zanubrutinib, as a potential treatment for CLL, with updated data expected to be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

About BEQALZI™ (sonrotoclax)

BEQALZI™ (sonrotoclax) is a foundational, next-generation and potentially best-in-class B-cell lymphoma 2 (BCL2) inhibitor with a unique pharmacokinetic and pharmacodynamic profile. Preclinical and clinical studies in early drug development have shown that sonrotoclax is a highly potent and specific BCL2 inhibitor with a short half-life and no drug accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL), and is in development as a monotherapy and in combination with other therapeutics, including zanubrutinib. To date, more than 2,200 patients have been enrolled across the broad sonrotoclax global development program.

INDICATION

BEQALZI™ (sonrotoclax) is a BCL-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

BEQALZI is contraindicated with strong CYP3A inhibitors at initiation and during the ramp-up phase due to the potential for an increased risk of tumor lysis syndrome (TLS).

WARNINGS & PRECAUTIONS

    Tumor Lysis Syndrome (TLS): BEQALZI can cause rapid tumor reduction and changes in blood chemistries consistent with TLS, which may be serious or life-threatening and require prompt management. TLS may occur as early as 4 hours after the first dose, with dose increases, or upon reinitiation following treatment interruption. Laboratory or clinical TLS occurred in 7% of patients who followed the recommended dose ramp-up. Assess all patients for TLS risk and initiate prophylaxis, including adequate hydration and antihyperuricemics. For patients at high risk of TLS, consider hospitalization with intravenous hydration and employ frequent monitoring. Monitor blood chemistries closely and manage abnormalities promptly. Interrupt BEQALZI for TLS; upon reinitiation, follow dose modification guidance in the Prescribing Information.
    Serious Infections: BEQALZI can cause fatal or serious infections. Serious infections occurred in 14% of patients; Grade 3-4 occurred in 17% (fatal: 2.6%). The most common Grade 3 or greater infection was pneumonia (10%). Monitor for signs and symptoms of infection and treat appropriately. Consider prophylactic antimicrobials and immunoglobulins. Interrupt, reduce dose, or permanently discontinue BEQALZI based on severity.
    Neutropenia: BEQALZI can cause serious or severe cytopenias, including neutropenia. Grade 3 or 4 decreases in neutrophils occurred in 18% of patients (Grade 4: 6%); febrile neutropenia occurred in 1.7% of all patients. Monitor complete blood counts throughout treatment. Interrupt treatment, reduce the dose, or permanently discontinue BEQALZI based on severity.
    Embryo-Fetal Toxicity: BEQALZI can cause fetal harm when administered to pregnant women. Advise patients of the potential risk to a fetus. Verify pregnancy status prior to initiation. Advise females to use effective contraception and males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose.

ADVERSE REACTIONS

The most common adverse reactions (≥15%) are pneumonia (16%) and fatigue (16%). The most common Grade 3-4 laboratory abnormalities (≥15%) are decreases in lymphocytes (29%) and neutrophils (18%).

DRUG INTERACTIONS

    Strong or Moderate CYP3A Inhibitors: Concomitant use increases BEQALZI exposure. Avoid use of strong CYP3A inhibitors during BEQALZI initiation and ramp-up. Avoid use of moderate CYP3A inhibitors at the 1 mg and 2 mg doses; for all other doses, reduce the BEQALZI dose with concomitant use. See approved labeling for dose modifications.
    Strong or Moderate CYP3A Inducers: Concomitant use decreases BEQALZI exposure. Avoid use.

SPECIAL POPULATIONS

Lactation: Advise women not to breastfeed during treatment with BEQALZI and for 1 week after the last dose.

To report SUSPECTED ADVERSE REACTIONS, contact BeOne Medicines at 1-877-828-5596 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full U.S. Prescribing Information.

About BeOne

BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential benefits of sonrotoclax; BeOne’s expectations regarding sonrotoclax’s clinical development, regulatory milestones, submissions and approvals; and BeOne’s plans, commitments, aspirations and goals under the caption “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent periodic report, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law.

To access BeOne media resources, please visit our Newsroom.

 

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Contacts

Investor Contact
Liza Heapes
+1 857-302-5663
ir@beonemed.com

Media Contact
Kyle Blankenship
+ 1 667-351-5176
media@beonemed.com

Experian Partners With ServiceNow to Scale Trusted Decisioning to Agentic AI

 LONDON - Friday, 15. May 2026 AETOSWire Print 

New global long‑term partnership embeds Experian’s Ascend capabilities directly into ServiceNow workflows, transforming client operations

 

(BUSINESS WIRE)--Experian, the global data and technology company, and ServiceNow (NYSE: NOW), the AI control tower for business reinvention, today unveil a new global multi-year partnership which harnesses the power of autonomous AI agents across platforms, helping businesses make faster and smarter decisions at scale.

Through this partnership, autonomous AI agents can gain the ability to act faster, and more consistently, starting with employee onboarding, third-party risk management and model life cycle governance use cases.

A major challenge for global organisations adopting agentic AI is achieving scale, with deployments often constrained by a lack of trusted data. In fact, industry research shows that data limitations are the primary barrier for eight in ten organisations. By connecting trusted intelligence directly into enterprise workflows, this partnership enables agentic AI to scale well beyond pilot deployments.

With the Experian Ascend Platform natively connected to the ServiceNow AI Platform, AI agents can seamlessly access Experian’s trusted insights and decisioning capabilities directly within existing workflows, giving clients the unique opportunity to automate intelligence at scale.

Keith Little, President - Experian Software Solutions, said:

“We see agentic AI as a fundamental change in how intelligent services are delivered, and this partnership brings together complementary strengths and a shared vision for building them the right way.

“By connecting our intelligence and decisioning capabilities in Ascend directly into ServiceNow’s workflow, businesses can operate with confidence at scale, while extending the impact of our capabilities into new industries and enterprise workflows. This partnership cements Experian’s position as a global leader in AI innovation, giving organisations the foundations to deploy agentic services with confidence.”

Cathy Mauzaize, President, EMEA at ServiceNow, said:

“Businesses are ready to move beyond experimentation, and this partnership gives them exactly what they need to scale. By bringing together ServiceNow's AI Platform, with Experian's world-leading decisioning and analytics platform, we're enabling deeper insights and delivering AI that can make smarter decisions and act faster in a secure environment that delivers real outcomes.”

The partnership will support a wide range of use cases for companies in highly regulated environments, starting with third-party risk management - including fraud and identity verification for businesses, employee onboarding and model risk management.

About Experian

Experian is a global data and technology company, powering opportunities for people and businesses around the world. We help to redefine lending practices, uncover and prevent fraud, simplify healthcare, deliver digital marketing solutions, and gain deeper insights into the automotive market, all using our unique combination of data, analytics and software. We also assist millions of people to realise their financial goals and help them to save time and money.

We operate across a range of markets, from financial services to healthcare, automotive, agrifinance, insurance, and many more industry segments.

We invest in talented people and new advanced technologies to unlock the power of data and to innovate. A FTSE 100 Index company listed on the London Stock Exchange (EXPN), we have a team of 25,200 people across 33 countries. Our corporate headquarters are in Dublin, Ireland. Learn more at experianplc.com.

© 2026 ServiceNow, Inc. All rights reserved. ServiceNow, the ServiceNow logo, Now, and other ServiceNow marks are trademarks and/or registered trademarks of ServiceNow, Inc. in the United States and/or other countries. Other company names, product names, and logos may be trademarks of the respective companies with which they are associated.

 

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Media contact:

Vicki Cook, Head of Corporate and B2B PR, Experian UK&I

Tel: +44 7977 798 173 / Email: vicki.cook@experian.com

For ServiceNow: press@servicenow.com

Organon to Present New Research on Access and Value at ISPOR 2026

 New findings will highlight contraception affordability, biosimilar adoption, and access-focused analyses across the women’s health and general medicines portfolio

 

(BUSINESS WIRE)--Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, will present data across women’s health, biosimilars, dermatology, and neurology at ISPOR 2026, the leading global scientific conference hosted by the International Society for Pharmacoeconomics and Outcomes Research. The conference, focused on health economics and outcomes research, will take place May 17-20, 2026, in Philadelphia, Pennsylvania.

Across 8 accepted abstracts, the data reflect Organon’s commitment to generating real-world evidence—rooted in lived experiences—that can help inform healthcare decision-making and improve health outcomes across a range of therapeutic areas.

“Health economics and outcomes research is critical to ensuring the right treatments reach patients and that health systems can sustain this approach over time,” said Juan Camilo Arjona Ferreira, MD, Head of R&D and Chief Medical Officer at Organon. “At ISPOR 2026, Organon is proud to share research findings about the budget impact, referral patterns, and real-world evidence of treatments for contraception, dermatology, and neurology conditions—each grounded in evidence that puts patient and provider perspectives at the center.”

Key data from Organon’s portfolio to be presented include:

An examination of the cost-effectiveness and budget impact of NEXPLANON® (etonogestrel implant) 68 mg Radiopaque in Brazil, including analyses that incorporate real-world utilization data and private payer perspectives.

A budget impact analysis of VTAMA® (tapinarof) cream, 1%, for the treatment of atopic dermatitis in adult and pediatric patients (2 years of age and older) from a U.S. Medicaid plan perspective.

Analyses related to POHERDY® (pertuzumab-dpzb) 420 mg/14 mL injection for intravenous use in certain HER2-positive breast cancer, as well as a real-world budget impact analysis of biosimilar adoption in a mid-sized Brazilian health maintenance organization.

An exploration of real-world referral patterns and healthcare utilization among patients with headache disorders in the United Kingdom, contributing to a better understanding of patient pathways and healthcare resource use in neurology.

Details on the abstracts noted above and additional presentations (including dates and times) can be found below. See below for full product information, including indication and selected safety information.

Date and Time (all times listed in EDT)

Abstract Name

Monday, May 18, 2026 | Poster Session 1 | 10:30 AM-1:30 PM

12:30 PM-1:30 PM: EE71 – Management Based on the Institutionalization of Health Technology Assessment (HTA): The Case of the Etonogestrel Subdermal Implant in a Brazilian Private Health Insurance Plan

12:30 PM-1:30 PM: EE57 – Budget Impact and Cost Calculator Model for POHERDY® (pertuzumab-dpzb) in the Treatment of HER2-Positive Breast Cancer

Monday, May 18, 2026 | Poster Session 2 | 4:00 PM-7:00 PM

 

6:00 PM-7:00 PM: EE174 – Cost-Effectiveness and Budget Impact of the Etonogestrel Subdermal Contraceptive Implant in Brazil

6:00 PM-7:00 PM: EE100 – Real-World Budget Impact Analysis of Biosimilar Adoption in a Mid-Sized Brazilian Health Maintenance Organization

6:00 PM-7:00 PM: EE172 – Cost-Effectiveness and Budget Impact of the Etonogestrel Subdermal Implant Incorporating Real-World Utilization Data from a Large Brazilian Private Health Insurer

6:00 PM-7:00 PM: HSD27 – Patient Characteristics and Utilization of Adalimumab-bwwd in the U.S. Department of Veterans Affairs Population

Tuesday, May 19, 2026 | Poster Session 4 | 4:00 PM-7:00 PM

6:00 PM-7:00 PM: EE412 – Budget Impact of Introducing Tapinarof, a New Aryl Hydrocarbon Receptor Agonist, for the Treatment of Atopic Dermatitis in Adult and Pediatric Patients from a U.S. Medicaid Plan Perspective

6:00 PM-7:00 PM: SA40 – Real-World Referral Patterns and Healthcare Utilization Among Patients with Headache Disorders in the United Kingdom

About NEXPLANON® (etonogestrel implant) 68 mg Radiopaque

Indication

NEXPLANON® is indicated for prevention of pregnancy in women of reproductive potential for up to 5 years.

Selected Safety Information

WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION and REMOVAL

Improper insertion of NEXPLANON increases the risk of complications.

Proper training prior to first use of NEXPLANON can minimize the risk of improper NEXPLANON insertion.

Because of the risk of complications due to improper insertion and removal NEXPLANON is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the NEXPLANON REMS.

CONTRAINDICATIONS

NEXPLANON should not be used in women who have known or suspected pregnancy; current or past history of thrombosis or thromboembolic disorders; liver tumors, benign or malignant, or active liver disease; undiagnosed abnormal uterine bleeding; known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past; and/or allergic reaction to any of the components of NEXPLANON.

WARNINGS and PRECAUTIONS

Risk of Complications Due to Improper Insertion and Removal

Complications of Insertion and Removal

NEXPLANON should be inserted subdermally so that it will be palpable after insertion, and this should be confirmed by palpation immediately after insertion. Failure to insert NEXPLANON properly may go unnoticed unless it is palpated immediately after insertion. Undetected failure to insert the implant may lead to an unintended pregnancy. Failure to remove the implant may result in continued effects of etonogestrel, such as compromised fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event.

 

Complications related to insertion and removal procedures may occur, e.g., pain, paresthesia, bleeding, hematoma, scarring, or infection. If NEXPLANON is inserted deeply (intramuscular or intrafascial), neural or vascular injury may occur.

 

Postmarketing reports of implants located within the vessels of the arm and the pulmonary artery may have been related to deep insertions or intravascular insertions. Endovascular or surgical procedures may be needed for removal.

 

Implant removal may be difficult or impossible if the implant is not inserted correctly, is inserted too deeply, not palpable, encased in fibrous tissue, or has migrated. If at any time the implant cannot be palpated, it should be localized, and removal is recommended. When an implant is removed, it is important to remove it in its entirety. Failure to remove the implant may result in continued effects of etonogestrel, such as compromised fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event.

Broken or Bent Implants

Cases of breakage or bending of implants while inserted within a patient’s arm have been reported. Cases of migration of a broken implant fragment within the arm have also occurred. These cases may be related to external forces, e.g., manipulation of the implant or contact sports. The release rate of etonogestrel may be slightly increased in a broken or bent implant, based on in vitro data.

NEXPLANON is available only through a restricted program under a REMS.

NEXPLANON REMS

NEXPLANON is only available through a restricted program under a REMS called NEXPLANON REMS because of the risk of complications due to improper insertion and removal.

Notable requirements of the NEXPLANON REMS include the following:

Healthcare providers must be certified with the program by enrolling and completing training on the proper insertion and removal of NEXPLANON prior to first use.

Pharmacies must be certified with the program and must only dispense NEXPLANON to certified healthcare providers who dispense NEXPLANON for insertion.

Wholesalers and distributors must be registered with the program and must only distribute to certified pharmacies and certified healthcare providers.

Further information is available at www.NEXPLANONREMS.com and 1-833-697-7367.

Changes in Menstrual Bleeding Patterns

After starting NEXPLANON, women are likely to have changes in their menstrual bleeding pattern. These may include changes in frequency, intensity, or duration. Abnormal bleeding should be evaluated as needed to exclude pathologic conditions or pregnancy. In clinical studies of the non-radiopaque etonogestrel implant, reports of changes in bleeding pattern were the most common reason for stopping treatment (11.1%). Women should be counseled regarding bleeding pattern changes that they may experience.

Ectopic Pregnancies

Be alert to the possibility of an ectopic pregnancy in women using NEXPLANON who become pregnant or complain of lower abdominal pain.

Thrombotic and Other Vascular Events

The use of combination hormonal contraceptives increases the risk of vascular events, including arterial events (strokes and myocardial infarctions) or deep venous thrombotic events (venous thromboembolism, deep venous thrombosis, retinal vein thrombosis, and pulmonary embolism). It is recommended that women with risk factors known to increase the risk of venous and arterial thromboembolism be carefully assessed. There have been postmarketing reports of serious arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using etonogestrel implants. NEXPLANON should be removed in the event of a thrombosis. Due to the risk of thromboembolism associated with pregnancy and immediately following delivery, NEXPLANON should not be used prior to 21 days postpartum. Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence. Consider removal of the NEXPLANON implant in case of long-term immobilization due to surgery or illness.

Ovarian Cysts

If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally, these enlarged follicles disappear spontaneously. Rarely, surgery may be required.

Carcinoma of the Breast and Reproductive Organs

Some studies suggest that the use of combination hormonal contraceptives might increase the incidence of breast cancer and increase the risk of cervical cancer or intraepithelial neoplasia. Women with a family history of breast cancer or who develop breast nodules should be carefully monitored.

Liver Disease

NEXPLANON should be removed if jaundice occurs.

Elevated Blood Pressure

The NEXPLANON implant should be removed if blood pressure rises significantly and becomes uncontrolled.

Gallbladder Disease

Studies suggest a small increased relative risk of developing gallbladder disease among combination hormonal contraceptive users. It is not known whether a similar risk exists with progestin-only methods like NEXPLANON.

Carbohydrate and Lipid Metabolic Effects

Prediabetic and diabetic women using NEXPLANON should be carefully monitored.

Depressed Mood

Women with a history of depressed mood should be carefully observed. Consideration should be given to removing NEXPLANON in patients who become significantly depressed.

Return to Ovulation

In clinical trials with the non-radiopaque etonogestrel implant (IMPLANON), the etonogestrel levels in blood decreased below sensitivity of the assay by one week after removal of the implant. In addition, pregnancies were observed to occur as early as 7 to 14 days after removal. Therefore, a woman should re-start contraception immediately after removal of the implant if continued contraceptive protection is desired.

Fluid Retention

Hormonal contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention. It is unknown if NEXPLANON causes fluid retention.

Contact Lenses

Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

ADVERSE REACTIONS

Clinical Trial Experience

The most common adverse reaction causing discontinuation of use of the implant in 3-year clinical trials was change in menstrual bleeding patterns (11.1%). The most common adverse reactions (≥5%) reported in these clinical trials were headache (24.9%), vaginitis (14.5%), weight increase (13.7%), acne (13.5%), breast pain (12.8%), abdominal pain (10.9%), and pharyngitis (10.5%). In a separate clinical trial to assess contraceptive efficacy and safety of NEXPLANON beyond 3 years, up to 5 years, a similar adverse reaction profile was observed as in Years 1 through 3. The most frequently reported adverse reaction >5% was intermenstrual bleeding (5.4%). Changes in menstrual bleeding patterns were the most frequently reported adverse reaction leading to discontinuation occurring in 4.0% of participants.

DRUG INTERACTIONS

Effects of Other Drugs on Hormonal Contraceptives

Substances decreasing the plasma concentrations of hormonal contraceptives and potentially diminishing the efficacy of hormonal contraceptives:

Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of hormonal contraceptives and potentially diminish the effectiveness of hormonal contraceptives or increase breakthrough bleeding. Women should use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with hormonal contraceptives, and continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.

Substances increasing the plasma concentrations of hormonal contraceptives:

Co-administration of certain hormonal contraceptives and strong or moderate CYP3A4 inhibitors may increase the serum concentrations of progestins, including etonogestrel.

Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors:

Significant changes (increase or decrease) in the plasma concentrations of progestin have been noted in cases of co-administration with HIV protease inhibitors, HCV protease inhibitors, or non-nucleoside reverse transcriptase inhibitors. These changes may be clinically relevant.

Effects of Hormonal Contraceptives on Other Drugs

Hormonal contraceptives may affect the metabolism of other drugs. Consequently, plasma concentrations may either increase (for example, cyclosporine) or decrease (for example, lamotrigine).

USE IN SPECIFIC POPULATIONS

Pregnancy

Rule out pregnancy before inserting NEXPLANON.

Lactation

Small amounts of contraceptive steroids and/or metabolites, including etonogestrel are present in human milk. No significant adverse effects have been observed in the production or quality of breast milk, or on the physical and psychomotor development of breastfed infants.

Hormonal contraceptives, including etonogestrel, can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women.

Pediatric Use

The safety and effectiveness of NEXPLANON have been established in women of reproductive potential. Safety and effectiveness of NEXPLANON are expected to be the same in postpubertal adolescents as in adult women. NEXPLANON is not indicated before menarche.

PATIENT COUNSELING INFORMATION

Advise women to contact their healthcare professional immediately if, at any time, they are unable to palpate the implant.

 

NEXPLANON does not protect against HIV or other STDs.

Before prescribing NEXPLANON, please read the Prescribing Information, including the Boxed Warning. The Patient Information also is available.

About VTAMA® (tapinarof) cream, 1%

INDICATIONS: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor (AhR) agonist indicated for:

the topical treatment of plaque psoriasis in adults

the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older

SELECTED SAFETY INFORMATION

Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.

Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain.

Before prescribing VTAMA cream, please read the Prescribing Information.

About POHERDY® (pertuzumab-dpzb)

INDICATIONS AND USAGE

Metastatic Breast Cancer (MBC)

POHERDY is indicated for use in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Early Breast Cancer (EBC)

POHERDY is indicated for use in combination with trastuzumab and chemotherapy for:

The neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer

The adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence

SELECTED SAFETY INFORMATION

LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY

Pertuzumab products can cause subclinical and clinical cardiac failure manifesting as decreased left ventricular ejection fraction (LVEF) and congestive heart failure (CHF). Evaluate cardiac function prior to and during treatment. Discontinue POHERDY treatment for a confirmed clinically significant decrease in left ventricular function.

Exposure to pertuzumab products can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception.

CONTRAINDICATIONS

POHERDY is contraindicated in patients with known hypersensitivity to pertuzumab products or to any of its excipients.

WARNINGS AND PRECAUTIONS

Left Ventricular Dysfunction

Pertuzumab products can cause left ventricular dysfunction, including symptomatic heart failure. Decreases in LVEF have been reported with drugs that block HER2 activity, including pertuzumab products.

Assess LVEF prior to initiation of POHERDY and at regular intervals during treatment to ensure that LVEF is within normal limits. If the LVEF declines and has not improved, or has declined further at the subsequent assessment, consider permanent discontinuation of POHERDY and trastuzumab.

In the pertuzumab-treated patients with MBC in CLEOPATRA, left ventricular dysfunction occurred in 4% of patients, and symptomatic left ventricular systolic dysfunction (LVSD) (congestive heart failure) occurred in 1% of patients. Patients who received prior anthracyclines or prior radiotherapy to the chest area may be at higher risk of decreased LVEF or left ventricular dysfunction.

In patients receiving pertuzumab as a neoadjuvant treatment in combination with trastuzumab and docetaxel in NeoSphere, LVEF decline >10% and a drop to <50% occurred in 8% of patients, and left ventricular dysfunction occurred in 3% of patients. LVEF recovered to ≥50% in all of these patients.

In patients receiving neoadjuvant pertuzumab in TRYPHAENA, LVEF decline >10% and a drop to <50% occurred in 7% of patients treated with pertuzumab plus trastuzumab and fluorouracil, epirubicin, and cyclophosphamide (FEC) followed by pertuzumab plus trastuzumab and docetaxel, 16% of patients treated with pertuzumab plus trastuzumab and docetaxel following FEC, and 11% of patients treated with pertuzumab in combination with docetaxel, carboplatin, and trastuzumab (TCH). Left ventricular dysfunction occurred in 6% of patients treated with pertuzumab plus trastuzumab and FEC followed by pertuzumab plus trastuzumab and docetaxel, 4% of patients treated with pertuzumab plus trastuzumab and docetaxel following FEC, and 3% of patients treated with pertuzumab in combination with TCH. Symptomatic LVSD occurred in 4% of patients treated with pertuzumab plus trastuzumab and docetaxel following FEC, 1% of patients treated with pertuzumab in combination with TCH, and none of the patients treated with pertuzumab plus trastuzumab and FEC followed by pertuzumab plus trastuzumab and docetaxel. LVEF recovered to ≥50% in all but 1 patient.

In patients receiving neoadjuvant pertuzumab in BERENICE, in the neoadjuvant period, LVEF decline ≥10% and a drop to <50% as measured by ECHO/MUGA assessment occurred in 7% of patients treated with pertuzumab plus trastuzumab and paclitaxel following dose-dense doxorubicin and cyclophosphamide (ddAC) and 2% of patients treated with pertuzumab plus trastuzumab and docetaxel following FEC. Ejection fraction decreased (asymptomatic LVD) occurred in 7% of patients treated with pertuzumab plus trastuzumab and paclitaxel following ddAC and 4% of the patients treated with pertuzumab plus trastuzumab and docetaxel following FEC in the neoadjuvant period. Symptomatic LVSD (New York Heart Association [NYHA] Class III/IV Congestive Heart Failure) occurred in 2% of patients treated with pertuzumab plus trastuzumab and paclitaxel following ddAC and none of the patients treated with pertuzumab plus trastuzumab and docetaxel following FEC in the neoadjuvant period.

In patients receiving adjuvant pertuzumab in APHINITY, the incidence of symptomatic heart failure (NYHA Class III/IV) with a LVEF decline ≥10% and a drop to <50% was 0.6%. Of the patients who experienced symptomatic heart failure, 47% of pertuzumab-treated patients had recovered (defined as 2 consecutive LVEF measurements above 50%) at the data cutoff. The majority of the events (86%) were reported in anthracycline-treated patients. Asymptomatic or mildly symptomatic (NYHA Class II) declines in LVEF ≥10% and a drop to <50% were reported in 3% of pertuzumab-treated patients, of whom 80% recovered at the data cutoff.

Pertuzumab products have not been studied in patients with a pretreatment LVEF value of <50%; a prior history of CHF; decreases in LVEF to <50% during prior trastuzumab therapy; or conditions that could impair left ventricular function such as uncontrolled hypertension, recent myocardial infarction, serious cardiac arrhythmia requiring treatment, or a cumulative prior anthracycline exposure to >360 mg/m2 of doxorubicin or its equivalent.

Embryo-Fetal Toxicity

Based on its mechanism of action and findings in animal studies, pertuzumab products can cause fetal harm when administered to a pregnant woman. Pertuzumab products are HER2/neu receptor antagonists. Cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death have been reported with use of another HER2/neu receptor antagonist (trastuzumab) during pregnancy.

Verify the pregnancy status of females of reproductive potential prior to the initiation of POHERDY. Advise pregnant women and females of reproductive potential that exposure to POHERDY in combination with trastuzumab during pregnancy or within 7 months prior to conception can result in fetal harm, including embryo-fetal death or birth defects. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of POHERDY in combination with trastuzumab.

Infusion-Related Reactions

Pertuzumab products can cause serious infusion reactions, including fatal events.

In CLEOPATRA, on the first day, when only pertuzumab was administered, infusion-related reactions occurred in 13% of patients, and <1% were Grade 3 or 4. The most common infusion reactions (≥1%) were pyrexia, chills, fatigue, headache, asthenia, hypersensitivity, and vomiting. During the second cycle when all drugs were administered on the same day, the most common infusion reactions in the pertuzumab-treated group (≥1%) were fatigue, dysgeusia, hypersensitivity, myalgia, and vomiting.

In APHINITY, when pertuzumab was administered in combination with trastuzumab and chemotherapy on the same day, infusion-related reactions occurred in 21% of patients, with <1% of patients experiencing Grade 3-4 events.

Observe patients closely for 60 minutes after the first infusion and for 30 minutes after subsequent infusions of POHERDY. If a significant infusion-related reaction occurs, slow or interrupt the infusion, and administer appropriate medical therapies. Monitor patients carefully until complete resolution of signs and symptoms. Consider permanent discontinuation in patients with severe infusion reactions.

Hypersensitivity Reactions/Anaphylaxis

Pertuzumab products can cause hypersensitivity reactions, including anaphylaxis.

In CLEOPATRA, the overall frequency of hypersensitivity/anaphylaxis reactions was 11% in pertuzumab-treated patients, with Grade 3-4 hypersensitivity reactions and anaphylaxis occurring in 2% of patients.

In NeoSphere, TRYPHAENA, BERENICE, and APHINITY, hypersensitivity/anaphylaxis events were consistent with those observed in CLEOPATRA. In APHINITY, the overall frequency of hypersensitivity/anaphylaxis was 5% in the pertuzumab-treated group. The incidence was highest in the pertuzumab plus TCH–treated group (8%), with 1% Grade 3-4 events.

Observe patients closely for hypersensitivity reactions. Severe hypersensitivity, including anaphylaxis and fatal events, has been observed in patients treated with pertuzumab products. Angioedema has been described in postmarketing reports. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use prior to administration of POHERDY.

ADVERSE REACTIONS

Metastatic Breast Cancer

The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy.

Neoadjuvant Treatment of Breast Cancer

The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and docetaxel were alopecia, diarrhea, nausea, and neutropenia.

The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and docetaxel when given for 3 cycles following 3 cycles of FEC were fatigue, alopecia, diarrhea, nausea, vomiting, and neutropenia.

The most common adverse reactions (>30%) with pertuzumab in combination with TCH were fatigue, alopecia, diarrhea, nausea, vomiting, neutropenia, thrombocytopenia, and anemia.

The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and paclitaxel when given for 4 cycles following 4 cycles of ddAC were nausea, diarrhea, alopecia, fatigue, constipation, peripheral neuropathy, and headache.

The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and docetaxel when given for 4 cycles following 4 cycles of FEC were diarrhea, nausea, alopecia, asthenia, constipation, fatigue, mucosal inflammation, vomiting, myalgia, and anemia.

Adjuvant Treatment of Breast Cancer

The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and chemotherapy were diarrhea, nausea, alopecia, fatigue, peripheral neuropathy, and vomiting.

Before prescribing POHERDY, please read the Prescribing Information, including the Boxed Warning about left ventricular dysfunction and embryo-fetal toxicity.

About HADLIMA® (adalimumab-bwwd) Injection

INDICATIONS AND USAGE

Rheumatoid Arthritis

HADLIMA is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs), for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

Juvenile Idiopathic Arthritis

HADLIMA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

Psoriatic Arthritis

HADLIMA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.

Ankylosing Spondylitis

HADLIMA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Crohn’s Disease

HADLIMA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

Ulcerative Colitis

HADLIMA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.

Limitations of Use:

The effectiveness of HADLIMA has not been established in patients who have lost response to or were intolerant to tumor necrosis factor (TNF) blockers.

Plaque Psoriasis

HADLIMA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HADLIMA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Hidradenitis Suppurativa

HADLIMA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.

Uveitis

HADLIMA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

SELECTED SAFETY INFORMATION

SERIOUS INFECTIONS

Patients treated with adalimumab products, including HADLIMA, are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue HADLIMA if a patient develops a serious infection or sepsis.

Reported infections include:

Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HADLIMA use and during therapy. Initiate treatment for latent TB prior to HADLIMA use.

Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.

Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with HADLIMA prior to initiating therapy in patients:

with chronic or recurrent infection

who have been exposed to TB

with a history of opportunistic infection

who resided in or traveled in regions where mycoses are endemic

with underlying conditions that may predispose them to infection

Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Do not start HADLIMA during an active infection, including localized infections.

Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.

If an infection develops, monitor carefully and initiate appropriate therapy.

Drug interactions with biologic products: A higher rate of serious infections has been observed in rheumatoid arthritis (RA) patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HADLIMA with other biologic DMARDs (eg, anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

Consider the risks and benefits of HADLIMA treatment prior to initiating or continuing therapy in a patient with known malignancy.

In clinical trials, more cases of malignancies were observed among adalimumab-treated subjects compared to control subjects.

Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated subjects. Examine all patients, particularly those with a history of prolonged immunosuppressant or psoralen and ultraviolet A (PUVA) therapy, for the presence of NMSC prior to and during treatment with HADLIMA.

In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.

Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

HYPERSENSITIVITY

Anaphylaxis and angioneurotic edema have been reported following adalimumab administration. If a serious allergic reaction occurs, stop HADLIMA and institute appropriate therapy.

HEPATITIS B VIRUS REACTIVATION

Use of TNF blockers, including HADLIMA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.

Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.

Exercise caution in patients who are carriers of HBV and monitor them during and after HADLIMA treatment.

Discontinue HADLIMA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HADLIMA after HBV treatment.

NEUROLOGIC REACTIONS

TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.

Exercise caution when considering HADLIMA for patients with these disorders; discontinuation of HADLIMA should be considered if any of these disorders develop.

HEMATOLOGIC REACTIONS

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products.

Consider stopping HADLIMA if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; exercise caution and monitor carefully.

AUTOIMMUNITY

Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome or autoimmune hepatitis. Discontinue treatment if symptoms of a lupus-like syndrome or autoimmune hepatitis develop.

IMMUNIZATIONS

Patients on HADLIMA should not receive live vaccines.

Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HADLIMA therapy.

Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero-exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (eg, upper respiratory, sinusitis), injection site reactions, headache, and rash.

Before prescribing HADLIMA, please read the Prescribing Information, including the Boxed Warning about serious infections and malignancies. The Medication Guide and Instructions for Use also are available.

About Organon

Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets.

Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook.

Cautionary Note Regarding Forward-Looking Statements

The information above reflects management’s current intentions and expectations for the future with respect to Organon’s expectations regarding milestone expenses, which constitute “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are subject to a number of risks, assumptions, uncertainties and other factors, such as the completion of Organon’s quarter-end closing process, including review by management and the audit committee of the Organon’s board of directors, which could result in material changes to the preliminary estimates described herein. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission ("SEC"), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings (as amended, where applicable), available at the SEC’s Internet site (www.sec.gov).

 

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Contacts

Media Contacts:

Janine Colavita

(732) 861-3806

Karissa Peer

(614) 314-8094

Investor Contacts:

Jennifer Halchak

(201) 275-2711

Renee McKnight

(551) 204-6129

 

Boomi Teams up With Gong to Bring Revenue AI to Boomi Agentstudio

CONSHOHOCKEN, Pa. - Friday, 15. May 2026

Gong's revenue AI is now natively available in the Boomi Enterprise Platform

 

(BUSINESS WIRE)--Boomi, the data activation company for AI, today announced a collaboration with Gong, the leader in Revenue AI, to bring revenue signals captured in Gong natively into the Boomi Enterprise Platform. This collaboration enables enterprises to establish an active data foundation designed to transform customer conversations into coordinated, automated actions across systems and functions enterprise-wide with Boomi Agentstudio.

Gong goes beyond capturing deal activity to surface real-time insights into risk, buyer intent, competitive dynamics, and key engagement signals. That intelligence moves from conversation to coordinated action, flowing across CRM, ERP, product, and operational systems with the governance and security that enterprises require. Through this collaboration, these signals can be served through Boomi Connect as live triggers for AI agents built within Boomi Agentstudio, enabling automated, cross-system workflows, from churn prevention and deal acceleration to post-sale expansion, with centralized oversight. The result is a more connected enterprise, where revenue AI and business operations execute in closer alignment.

“The agentic enterprise isn’t built on static data, it’s powered by real-time signals that drive action," said Ed Macosky, Chief Product & Technology Officer at Boomi. "With the depth of Gong’s revenue insights, Boomi provides the foundation to operationalize them within its agent network. Together, we’re helping enterprises close the loop between what customers are saying and how they translate those insights into meaningful, automated action."

"The Gong Revenue AI OS orchestrates customer insights across critical revenue workflows, and this integration extends that value across the enterprise," said Eran Aloni, Executive Vice President of Product Strategy and Ecosystem at Gong. "With Boomi, we’re enabling organizations to harness Gong’s AI-driven insights and signals within the Boomi Enterprise Platform to drive coordinated outcomes for customers, seamlessly and at scale."

As part of this collaboration:

Boomi Connect is designed to provide optimized, governed connectivity to Gong, giving revenue teams access to call data, insights, and rep activity signals with high levels of governance and security. No custom code.

Gong will be registered in Boomi’s MCP Registry, making its revenue signals and engagement data accessible to any AI agent on the platform. AI builders get a ready-made, governed data source to act on live Gong signals without building infrastructure from scratch.

Boomi is also listed as a native integration on the Gong Collective, giving joint customers a governed, real-time gateway to surface Gong's revenue AI - conversation data, signals, engagement insights, and more - directly inside any MCP-compatible AI tool.

A pre-built “Gong recipe” is also now available in the Boomi Marketplace, enabling joint customers to quickly deploy workflows without the need for custom development.

Boomi Agentstudio turns signals from Gong into automated actions across the enterprise within its platform. Agents can attach Gong call context to support tickets, route product feedback from customer conversations into roadmap tools, trigger finance workflows tied to deal milestones, and surface competitive intelligence into enablement systems in real time.

Boomi’s Agent Control Tower provides centralized visibility and governance over every agent-driven action initiated by Gong signals, ensuring control and accountability at scale. Every action in the Boomi Agent Control Tower is logged, auditable, and bound by enterprise policy, giving security and compliance teams the confidence to scale AI without scaling risk.

Boomi World

Join the Boomi World keynotes live in Chicago on LinkedIn to hear the latest from Boomi executives, customers, and partners:

#BoomiWorld 2026 Live: Day 2 — Thursday, May 14, 9 a.m. Central

Learn more about Boomi World

Learn more about Boomi World

See all of Boomi’s announcements this week in the Boomi Newsroom

Follow official event hashtag #BoomiWorld for event coverage on LinkedIn, X, and Instagram

About Boomi

Boomi, the data activation company for AI, powers the agentic enterprise by bringing data to life across the business. The Boomi Enterprise Platform is the active data foundation that delivers essential agentic infrastructure to drive agentic transformation. By unifying agent design and governance, API and MCP management, integration and automation, and data management into a single platform, Boomi enables organizations to harness the power of AI with secure, scalable connectivity. Trusted by over 30,000 customers and supported by a network of 800+ partners, Boomi helps organizations of all sizes achieve agility, efficiency, and innovation at scale. Discover more at boomi.com.

© 2026 Boomi, LP. Boomi, the ‘B’ logo, and Boomiverse are trademarks of Boomi, LP or its subsidiaries or affiliates. All rights reserved. Other names or marks may be the trademarks of their respective owners.

 

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Media Contact:

Kristen Walker

Global Communications

kristenwalker@boomi.com

Boomi Announces Intent to Acquire Lunar.dev to Deliver Governed Agent Connectivity Across the Enterprise

 Proposed acquisition extends Boomi’s AI gateway capabilities, enabling enterprises to govern massive volumes of traffic for production-ready AI

 

(BUSINESS WIRE)--Boomi, the data activation company for AI, today announced it has signed a letter of intent to acquire Lunar.dev, an innovator in AI and MCP gateway. The proposed acquisition is expected to enrich the Boomi Enterprise Platform and Boomi Connect with advanced capabilities to govern and scale AI usage across enterprise systems.

As organizations move from AI experimentation to production, controlling how agents and AI applications interact with LLMs at scale has become critical. Lunar.dev addresses this need with an AI gateway that delivers granular, policy-driven control over AI interactions, with the visibility, security, and performance required for enterprise environments. These capabilities enable organizations to move from pilot to production with confidence, ensuring AI operates reliably, securely, and within defined guardrails.

“At Boomi, we see a clear shift from AI experimentation to real-world deployment,” said Steve Lucas, Chairman and CEO of Boomi. “Our intent to acquire Lunar.dev is focused on one priority: giving customers control over every interaction between AI, data, and applications. That’s essential to building trust and scaling AI with confidence.”

Strengthening AI Governance and Control

With Lunar.dev, Boomi will introduce a centralized and decentralized control layer for managing AI interactions across the enterprise. This enables organizations to:

Enforce fine-grained policy and governance across every AI interaction

Secure and precisely control AI access to enterprise data and systems

Achieve full observability into AI activity, including prompts, responses, and downstream actions

Operate AI at scale with high-performance routing and execution

Deploy with flexibility, including full tenant control across on-premises, private cloud, and sovereign environments

Expanding Boomi Connect with Governed Agent Connectivity

Lunar.dev is expected to become a key component of Boomi Connect, extending Boomi’s ability to enable secure, governed connectivity between AI tools (e.g. Claude, Copilot, Gemini) and enterprise applications through 1000+ managed, MCP-enabled tools. With Lunar.dev, Boomi will add a MCP gateway that additionally provides:

Cost management and observability

Scalable AI connectivity across hybrid and multi-cloud environments

Together with the Boomi MCP Registry, organizations can discover, govern, and manage AI services through a centralized catalog across Boomi and third-party environments.

These capabilities establish Boomi Connect as a unified foundation for governed agent connectivity, enabling organizations to scale AI securely across the enterprise.

Supporting the Next Phase of Agentic AI

This move reflects Boomi’s vision for the agentic enterprise: moving beyond fragmented tools toward a unified platform for connectivity, automation, and governance.

“This is about helping customers turn AI into a trusted, operational capability,” Lucas added. “With governance embedded at every layer, organizations can move faster while staying in control.”

Boomi World

Join the Boomi World keynotes live in Chicago on LinkedIn to hear the latest from Boomi executives, customers, and partners:

#BoomiWorld 2026 Day 1 — Wednesday, May 13, 9 a.m. Central

#BoomiWorld 2026 Live: Day 2 — Thursday, May 14, 9 a.m. Central

Learn more about Boomi World

Learn more about Boomi World

See all of Boomi’s announcements this week in the Boomi Newsroom

Follow official event hashtag #BoomiWorld for event coverage on LinkedIn, X, and Instagram

About Boomi

Boomi, the data activation company for AI, powers the agentic enterprise by bringing data to life across the business. The Boomi Enterprise Platform is the active data foundation that delivers essential agentic infrastructure to drive agentic transformation. By unifying agent design and governance, API and MCP management, integration and automation, and data management into a single platform, Boomi enables organizations to harness the power of AI with secure, scalable connectivity. Trusted by over 30,000 customers and supported by a network of 800+ partners, Boomi helps organizations of all sizes achieve agility, efficiency, and innovation at scale. Discover more at boomi.com.

© 2026 Boomi, LP. Boomi, the ‘B’ logo, and Boomiverse are trademarks of Boomi, LP or its subsidiaries or affiliates. All rights reserved. Other names or marks may be the trademarks of their respective owners.

 

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Media Contact:

Kristen Walker

Global Communications

kristenwalker@boomi.com

 

Corona Global Named Most Valuable Beer Brand in Kantar BrandZ Rankings for Third Consecutive Year

 LONDON - 

AB InBev Holds 8 of the Top 10 Most Valuable Beer Brands Globally

 

(BUSINESS WIRE)--Corona global has been recognized as the most valuable beer brand in the world for the third consecutive year in Kantar's BrandZ 2026 Most Valuable Global Brands report, released today. Eight out of the top ten most valuable global beer brands belong to AB InBev (Brussel:ABI) (BMV:ANB) (JSE:ANH) (NYSE:BUD), according to the report ranking the best brands in the world.

In 2025, Corona led AB InBev’s performance, increasing revenue by 8.3% outside of its home market with double-digit volume growth in 30 markets, while Corona Cero delivered strong double-digit volume growth. As the brand celebrated its 100th anniversary, Corona launched its global “Corona 100” platform, including a multi-year sponsorship of a renowned concert at Copacabana Beach in Rio de Janeiro. Strong momentum continued in Q1 2026, with AB InBev delivering all-time high revenues and volume growth, led by Corona, which grew 16% outside its home market following a successful debut as the world’s first global beer sponsor of The Winter Olympics.

In Kantar’s BrandZ 2026 rankings, Corona is followed by Budweiser as the second most valuable beer brand in the world, with Modelo, Michelob ULTRA, Brahma, Bud Light, Skol and Stella Artois helping AB InBev secure 8 of the world’s top 10 most valuable beer brands.

“Corona’s recognition as the most valuable beer brand in the world for three consecutive years reflects our approach to building brands for long-term, sustainable growth,” said Marcel Marcondes, Global Chief Marketing Officer. “For AB InBev to have 8 of the top 10 beer brands in Kantar BrandZ’s 2026 rankings underscores the focus, consistency and creative effectiveness of our teams and partners around the world.”

BrandZ charts the way in which global brands have continued to evolve and innovate. Now in its 21st edition, it spotlights the importance of building meaningful difference where a brand meets consumer needs, stands out from competitors and remains top-of-mind in its sector for a prolonged period.

“Corona’s performance in Kantar BrandZ’s global rankings shows what strong brands achieve when they are built with discipline, over time. Brand value comes from being meaningfully different in ways people recognise, showing up consistently and staying relevant as the world changes. That doesn’t change, even as technology introduces new ways for people to discover and interact with brands. Marketers still need to make clear decisions about what their brand stands for and how it shows up in the real world. That’s something the Corona team continues to get right,” said Paul Zwillenberg, CEO of Kantar.

Kantar BrandZ is a global ranking that assesses brand value by combining financial data and extensive brand equity research, offering an in-depth view of over 22,000 brands in 54 markets.

About AB InBev

Anheuser-Busch InBev (AB InBev) is a publicly traded company (Euronext: ABI) based in Leuven, Belgium, with secondary listings on the Mexico (MEXBOL: ANB) and South Africa (JSE: ANH) stock exchanges and with American Depositary Receipts on the New York Stock Exchange (NYSE: BUD). As a company, we dream big to create a future with more cheers. We are always looking to serve up new ways to meet life’s moments, move our industry forward and make a meaningful impact in the world. We are committed to building great brands that stand the test of time and to brewing the best beers using the finest ingredients. Beer is the drink for moderation, and for over a century, AB InBev has championed responsible drinking. We are committed to providing our consumers with Balanced Choices to enjoy on any occasion. We also invest in marketing that aims to reinforce positive behaviors, and we work with communities, customers, and partners to promote responsible consumption through evidence-based initiatives.

Our diverse portfolio of well over 400 beer brands includes global brands Budweiser®, Corona®, Stella Artois® and Michelob Ultra®; multi-country brands Beck’s®, Hoegaarden® and Leffe®; and local champions such as Aguila®, Antarctica®, Bud Light®, Brahma®, Cass®, Castle®, Castle Lite®, Cristal®, Harbin®, Jupiler®, Modelo Especial®, Quilmes®, Victoria®, Sedrin®, and Skol®. Our brewing heritage dates back more than 600 years, spanning continents and generations. From our European roots at the Den Hoorn brewery in Leuven, Belgium. To the pioneering spirit of the Anheuser & Co brewery in St. Louis, US. To the creation of the Castle Brewery in South Africa during the Johannesburg gold rush. To Bohemia, the first brewery in Brazil. Geographically diversified with a balanced exposure to developed and developing markets, we leverage the collective strengths of approximately 137 000 colleagues based in more than 40 countries worldwide. For 2025, AB InBev’s reported revenue was 59.3 billion USD (excluding JVs and associates).

About Kantar

Kantar is the world’s leading marketing data and analytics business. We deliver the intelligence needed to power brand growth.

We provide the signals that help organisations act quickly and confidently. We empower brands to make effective marketing decisions based on predictive evidence. And we help them craft powerful growth strategies rooted in the connection between consumers, brands and enterprise value. All this is powered by our uniquely robust human and synthetic data, our unrivalled IP, our AI-native platform and the team of global brand experts that bring this all together.

About Kantar BrandZ

Kantar BrandZ is the global currency when assessing brand value, quantifying the contribution of brands to business’ financial performance. Kantar’s annual global and local brand valuation rankings combine rigorously analysed financial data, with extensive brand equity research. Since 1998, BrandZ has shared brand-building insights with business leaders based on interviews with 4.6 million consumers, for over 22,000 brands in 54 markets. Discover more about Kantar BrandZ here.

 

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Contacts

AB InBev contact

media.relations@ab-inbev.com

 

Enterprise AI Hits the Wall: NTT DATA Research Reveals Growing Privacy and Sovereignty Barriers

 TOKYO & LONDON -

Demands for privacy and sovereignty expose limits of architectures built for centralized and borderless data flows.

Data jurisdiction has become a core design parameter, shifting away from globally integrated systems to regionally bounded architectures.

Organizations that redesign early are gaining a measurable edge in AI readiness and scale.

 

(BUSINESS WIRE)--NTT DATA, a global leader in AI, digital business and technology services, today released new research showing that enterprise AI is outgrowing the architecture and infrastructure beneath it as data privacy and sovereignty requirements tighten. The research finds a widening split between enterprises that are redesigning AI for control, locality and security, and organizations still layering AI into environments that were not built to support these requirements.

For years, enterprise architecture moved data across systems, clouds, applications and borders with increasing speed and efficiency. AI is exposing the limits of that model. Sensitive data must be protected, workloads must run inside defined jurisdictions, and models must be governed under tighter controls. Data cannot always move with the speed and fluidity many AI systems expect, making jurisdiction a core architectural constraint. As a result, private and sovereign AI have become critical considerations.

NTT DATA’s 2026 Global AI Report: A Playbook for Private and Sovereign AI reveals a gap between what organizations know they need and what they are ready to build:

More than 95% of respondents say private and sovereign AI are important, but only 29% are prioritizing sovereign AI in a concrete, near-term way.

About 35% of CAIOs identify building, integrating and managing complex AI models in private or sovereign environments as their top barrier to adoption, and nearly 60% of AI leaders cite cross-border data restrictions as a major challenge.

Only 38% report high confidence in their cloud security posture—a critical foundation for both private and sovereign AI.

Private and sovereign AI are related, but distinct. Private AI focuses on protecting sensitive enterprise data, controlling access and limiting exposure. Sovereign AI focuses on ensuring that AI systems, data and operating environments meet jurisdictional, regulatory or national and regional control requirements.

"As AI evolves, private and sovereign approaches are testing enterprise readiness," said Abhijit Dubey, CEO and Chief AI Officer, NTT DATA, Inc. "The organizations that are succeeding are going beyond regulatory compliance and risk mitigation. They are building the operating foundation for AI that can perform across markets, jurisdictions and business environments. Our research shows AI leaders are pulling ahead by treating architecture, infrastructure and governance as strategic requirements."

The report identifies five shifts defining the next phase of enterprise AI:

AI is running into a wall – and it’s not the model. The constraint is no longer model performance alone. AI now requires greater control over compute, data access, security and locality—exposing the limits of infrastructure built for centralized, borderless data flows.

Data jurisdiction is now an architectural constraint. Data can still move, just not the way AI needs. Because AI depends on continuous access and movement of data, jurisdiction is shaping where data lives, where models run and how systems are designed and governed.

Everyone sees the shift—few are acting on it. More than 95% of organizations recognize the importance of private and sovereign AI, but only around one-third are prioritizing sovereign AI in a concrete, near-term way.

Leaders are redesigning early and moving decisively—creating competitive divergence. Leaders are moving decisively, aligning infrastructure, governance and operating models early. This is enabling them to move faster from pilots to scaled deployments, while others struggle to adapt.

Private and sovereign AI sounds like independence—in practice, they rely on tightly orchestrated ecosystems. More than half of organizations cite integration complexity as their top challenge. As organizations push for greater control, they are also increasing the complexity and interdependence of their AI ecosystem partners coordinating across the stack.

Together, private and sovereign AI are changing how AI systems are built, governed and scaled. Organizations that redesign early are better positioned in regulated, distributed and data-sensitive environments. Those that layer AI into architectures that were not built for control, locality or data-flow constraints may struggle to turn their AI ambition into durable value.

The report draws on two studies engaging a total of nearly 5,000 senior decision-makers across more than a dozen industries, more than 30 markets and five regions. It is part of NTT DATA's global research series on strategies that separate AI leaders from the market.

About NTT DATA

NTT DATA is a $30+ billion business and technology services leader, serving 75% of the Fortune Global 100. We are committed to accelerating client success and positively impacting society through responsible innovation. We are one of the world’s leading AI and digital infrastructure providers, with unmatched capabilities in enterprise-scale AI, cloud, security, connectivity, data centers and application services. Our consulting and industry solutions help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have experts in more than 70 countries. We also offer clients access to a robust ecosystem of innovation centers as well as established and start-up partners. NTT DATA is part of NTT Group, which invests over $3 billion each year in R&D.

Visit us at nttdata.com

 

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NTT DATA, Inc.

Dan.Smith@nttdata.com