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FDA Approves Merck’s Once-Daily IDVYNSO™ (doravirine/islatravir)

IDVYNSO is approved for adults with virologically suppressed HIV-1 with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine

IDVYNSO is the first and only non-INSTI, tenofovir-free, once-daily, complete two-drug regimen to demonstrate non-inferior efficacy in a head-to-head Phase 3 trial versus three-drug regimen BIKTARVY^®i (BIC/FTC/TAF)

RAHWAY, N.J.–(BUSINESS WIRE)–
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved IDVYNSO™, a new, two-drug single-tablet regimen of 100 mg doravirine and 0.25 mg islatravir, for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine. IDVYNSO is contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers and lamivudine (3TC) or emtricitabine (FTC). Co-administration with these drugs may decrease the effectiveness of IDVYNSO. See additional selected safety information on the following pages. IDVYNSO (pronounced ihd-VIHN-soh) will be available in pharmacies after May 11.

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“Advances in HIV treatment mean more people living with HIV are living longer — a remarkable achievement,” said Carl Baloney, Jr., president and chief executive officer of AIDS United. “People aging with HIV face additional health challenges, including managing multiple chronic conditions and medications at the same time. It is essential that management of HIV considers these factors in addition to virologic suppression when choosing an HIV treatment regimen.”

“IDVYNSO combines islatravir, a next-generation NRTI with multiple mechanisms of action, including translocation inhibition, with doravirine, an NNRTI with an established efficacy and safety profile. As the only two-drug, non-INSTI, tenofovir-free regimen, IDVYNSO expands therapeutic diversity beyond the currently available oral treatment options,” said Dr. Eliav Barr, senior vice president and chief medical officer, Merck Research Laboratories. “As the health needs of adults living with HIV change over time, IDVYNSO gives clinicians a new choice for HIV treatment. This approval marks an important new chapter in Merck’s long-standing commitment to research and discovery for people living with HIV.”

IDVYNSO is a complete regimen; co-administration with other antiretroviral medications for treatment of HIV-1 infection is not recommended. Severe skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis, have been reported with doravirine-containing regimens. Drug Rash with Eosinophilia and Systemic Symptoms was reported with IDVYNSO. Concomitant use of IDVYNSO and certain other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of IDVYNSO and possible development of resistance, or possible clinically significant adverse reactions from greater exposures of a component of IDVYNSO. See additional selected safety information on the following pages.

“IDVYNSO is the first non-INSTI, tenofovir-free, two-drug regimen to demonstrate non-inferior efficacy to standard oral antiretroviral regimens, including BIKTARVY. This makes IDVYNSO a potential alternative for people with virologically suppressed HIV who may need to switch their treatment,” said Dr. Amy Colson, director of research at Community Resource Initiative, Boston, Massachusetts.

Phase 3 studies supporting approval of IDVYNSO

The efficacy and safety of IDVYNSO is supported by Week 48 data from two randomized, active-controlled, non-inferiority trials [Trial 052 (NCT05630755) and Trial 051 (NCT05631093)] in virologically-suppressed (HIV-1 RNA less than 50 copies per mL) adults living with HIV. Participants must have been stably suppressed on their baseline regimen for at least 3 months prior to trial entry and had no history of treatment failure. Across the two trials, a total of 708 participants received once-daily IDVYNSO; of these, 81 (11%) participants were aged 65 years and older, including 10 (1%) aged 75 years and older.

In the double-blind Trial 052, participants were switched from BIKTARVY [bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)] to IDVYNSO. A total of 513 participants were randomized (2:1) and were switched to once-daily IDVYNSO (n=342) or remained on BIC/FTC/TAF (n=171). At baseline, participants had a mean age of 48 years (range: 19 to 77), 21% of participants were female, 61% were White, 31% were Black/African American, and 6% were Asian. A total of 23% identified as Hispanic/Latino.

In the open-label Trial 051, participants were switched from an oral ART (antiretroviral therapy) regimen to IDVYNSO. A total of 551 participants were randomized (2:1) and were switched to once-daily IDVYNSO (n=366) or remained on their baseline ART (bART) (n=185). Randomization was stratified by bART. At baseline, participants had a mean age of 50 years (range: 18 to 83), 40% of participants were female, 39% were White, 45% were Black/African American, and 5% were Asian. A total of 15% identified as Hispanic/Latino. At enrollment, 64% of the participants were receiving integrase strand transfer inhibitor (INSTI)-based regimens, 5% protease inhibitor (PI)-based regimens (including combinations with INSTI), and 30% were receiving other regimens.

Efficacy profile of IDVYNSO

IDVYNSO was non-inferior to BIC/FTC/TAF (in Trial 052) and bART (in Trial 051) as assessed by the proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48.

• In the double-blind Trial 052, results for the primary endpoint (HIV-1 RNA ≥50 copies/mL) showed that 1% of participants who were switched to IDVYNSO (n=342) had a viral load of ≥50 copies/mL at Week 48, compared to 1% who continued on BIC/FTC/TAF (n=171; treatment difference 0.9%, 95% CI, -1.9%, 2.9%). At Week 48, results from the secondary endpoint showed that 92% of participants who switched to IDVYNSO maintained viral suppression (HIV-1 RNA <50 copies/mL) compared to 94% of participants who continued receiving BIC/FTC/TAF.

• In the open-label Trial 051, results for the primary endpoint (HIV-1 RNA ≥50 copies/mL) showed that 1% of participants who were switched to IDVYNSO (n=366) had a viral load of ≥50 copies/mL at Week 48, compared to 5% who continued on bART (n=185; treatment difference -3.6%, 95% CI, -7.8%, -0.8%). At Week 48, results from the secondary endpoint showed that 96% of participants who switched to IDVYNSO maintained viral suppression (HIV-1 RNA <50 copies/mL) compared to 92% of participants who continued on bART.

In both trials, treatment outcomes between treatment groups were similar across subgroups by age, sex and race, and in Trial 051, also by bART regimens. In participants aged 65 years and older who received IDVYNSO in both trials, no overall differences in safety or effectiveness were observed between these participants and younger participants, but greater sensitivity of some older individuals cannot be ruled out.

Safety and tolerability profile of IDVYNSO

The safety profile of IDVYNSO was generally comparable to BIC/FTC/TAF in Trial 052 and to oral bART regimens in Trial 051. In Trial 052, by Week 48, 3% in the IDVYNSO group and 2% in the BIC/FTC/TAF group had adverse events leading to discontinuation of study medication. In Trial 051, by Week 48, 0.5% in the IDVYNSO group and 2% in the bART group had adverse events leading to discontinuation of study medication.

The most common adverse reactions (all grades) reported in greater than or equal to 2% of participants in any treatment group in Trials 052 and 051 through Week 48 were as follows:

• In Trial 052 (IDVYNSO vs BIC/FTC/TAF, respectively): diarrhea (1% vs 1%), dizziness (1% vs 0%), fatigue (1% vs 1%), abdominal distention (1% vs 0%), headache (1% vs 0%), weight increase (less than 1% vs 0%).

• In Trial 051 (IDVYNSO vs bART, respectively): diarrhea (3% vs 0%), dizziness (2% vs 1%), fatigue (2% vs 1%), abdominal distention (2% vs 0%), headache (2% vs 1%), weight increase (2% vs 0%).

Trial participants taking IDVYNSO had minimal change in weight from baseline. The mean change in weight from baseline at Week 48 was -0.03 kg in the IDVYNSO group vs. 0.28 kg in the BIC/FTC/TAF group in Trial 052 and 0.94 kg in the IDVYNSO group vs. -0.15 kg in the bART group in Trial 051. Four of the six participants with adverse reactions of weight increased switched from a bART regimen containing efavirenz and/or tenofovir disoproxil fumarate in Trial 051.

The Merck Access Program for IDVYNSO

Merck offers support to individuals who are prescribed IDVYNSO, including information about individual insurance coverage and out-of-pocket costs, co-pay assistance for eligible, commercially insured individuals, and how individuals may access IDVYNSO through The Merck Access Program. For additional information, healthcare providers and individuals can call 1-877-709-4455 or visit merckaccessprogram-IDVYNSO.com.

About IDVYNSO

IDVYNSO is a fixed-dose combination of two medicines, doravirine with islatravir. Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase. Islatravir is a potent, next-generation nucleoside analog reverse transcriptase inhibitor (NRTI) that blocks HIV-1 replication by multiple mechanisms including:

• inhibition of reverse transcriptase translocation, resulting in immediate chain termination, and

• induction of structural changes in the viral DNA (delayed chain termination).

Selected Safety Information for IDVYNSO

Contraindications

IDVYNSO is contraindicated when co-administered with:

• drugs that are strong cytochrome P450 (CYP)3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of IDVYNSO.

• lamivudine (3TC) or emtricitabine (FTC) as significant decreases in islatravir-triphosphate (ISL-TP) concentrations may occur, which may decrease the effectiveness of IDVYNSO. (See Drug Interactions)

Warnings and Precautions

Severe skin reactions, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), have been reported during postmarketing experience with doravirine-containing regimens. In addition, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome) was reported with IDVYNSO in a clinical trial. Discontinue IDVYNSO, and other medications associated with these reactions, immediately if a painful rash with mucosal involvement, a progressive severe rash, or a rash with constitutional symptoms, eosinophilia, lymphadenopathy, or other organ involvement develops. Close clinical monitoring, and appropriate therapy should be initiated.

The concomitant use of IDVYNSO and certain other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of IDVYNSO and possible development of resistance and possible clinically significant adverse reactions from greater exposures of a component of IDVYNSO.

Consider the potential for drug interactions prior to and during IDVYNSO therapy, review concomitant medications during IDVYNSO therapy, and monitor for adverse reactions. (See Drug Interactions)

Adverse Reactions

The most common adverse reactions (incidence ≥ 2%, all grades in any treatment group) reported in virologically suppressed participants in the IDVYNSO treatment groups from 2 clinical trials, respectively, were: diarrhea (3% and 1%), dizziness (2% and 1%), fatigue (2% and 1%), abdominal distension (2% and 1%), headache (2% and 1%) and increased weight (2% and <1%).

A single case of severe immune thrombocytopenia (platelet count nadir of 2 x10⁹/L) characterized by abrupt onset of subcutaneous hematoma, petechiae, and hematuria was reported in a participant 32 days after initiating IDVYNSO. The case resolved with discontinuation of IDVYNSO, in conjunction with treatments including corticosteroids and IVIG. Among all participants in Trials 052 and 051, there were no patterns of platelet decreases over time with IDVYNSO and no differences between treatment arms in mean change from baseline in platelet count.

Drug Interactions

IDVYNSO is a complete regimen; co-administration with other antiretroviral medications for treatment of HIV-1 infection is not recommended.

Co-administration of IDVYNSO with a CYP3A inducer decreases doravirine plasma concentrations, which may reduce the efficacy of IDVYNSO. If IDVYNSO is co-administered with rifabutin, one tablet of doravirine should be taken approximately 12 hours after the dose of IDVYNSO. Co-administration of IDVYNSO with other moderate CYP3A inducers is not recommended.

Co-administration of IDVYNSO and drugs that are inhibitors of CYP3A may result in increased plasma concentrations of doravirine.

Co-administration of IDVYNSO is not recommended with deoxycytidine kinase (dCK) substrates (e.g., nucleoside antimetabolites) as they may reduce the exposure of islatravir-triphosphate or with adenosine deaminase (ADA) inhibitors (e.g., pentostatin) as they may increase the exposure of islatravir. (see Contraindications)

Use in Specific Populations

Clinical trials in virologically suppressed participants who received IDVYNSO included 81 (11%) participants aged 65 years and older, including 10 (1%) aged 75 years and older. Overall differences in response have not been identified between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

IDVYNSO does not have activity against hepatitis B virus (HBV). Patients with HBV coinfection who switch to IDVYNSO from an antiretroviral regimen with activity against HBV, and patients on IDVYNSO who are newly diagnosed with HBV coinfection, should be closely monitored and specific anti-HBV therapy should be considered, as clinically appropriate.

Merck’s Commitment to HIV

For 40 years, Merck has been committed to scientific research and discovery in HIV leading to scientific breakthroughs that have helped change HIV treatment. Our work has helped pioneer the development of new options across multiple drug classes to help those impacted by HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV. We are researching for real life and want to ensure people are not defined by HIV. Our work focuses on transformational innovations, collaborations with others in the global HIV community and access initiatives aimed at helping to end the HIV epidemic for everyone.

About Merck’s HIV research

Islatravir is under evaluation in multiple ongoing early and late-stage clinical trials in combination with other antiretrovirals for potential once-weekly treatments for HIV-1, with islatravir serving as the anchor medicine in these two-drug regimens. Islatravir in combination with Gilead’s lenacapavir is in Phase 3 development as a novel oral once-weekly treatment for HIV-1 [ISLEND-1 (NCT06630286) and ISLEND-2 (NCT06630299)], and islatravir in combination with our company’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) ulonivirine (MK-8507) is in Phase 2b development [MK-8591B-060 (NCT06891066) and MK-8591B-062 (NCT07266831)] as an oral once-weekly treatment.

MK-8527 is the company’s investigational, novel, once-monthly oral candidate for pre-exposure prophylaxis (PrEP) for HIV-1. In collaboration with the Gates Foundation, the Phase 3 EXPrESSIVE-10 trial (MK-8527-010, NCT07071623) is evaluating the safety and efficacy of MK-8527 as PrEP to reduce the risk of sexually acquired HIV-1 infection among women and adolescent girls in sub-Saharan Africa. The Phase 3 EXPrESSIVE-11 trial (MK-8527-011, NCT07044297) in 16 countries is evaluating the safety and efficacy of MK-8527 as PrEP to reduce the risk of sexually acquired HIV-1 infection among people likely to be exposed to HIV-1. Both trials are now enrolling.

For an overview of Merck’s HIV treatment and prevention clinical development program, please click here.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “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 based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for IDVYNSO™ (doravirine and islatravir) at https://www.merck.com/product/usa/pi_circulars/i/idvynso/idvynso_pi.pdf and Patient Information for IDVYNSO at https://www.merck.com/product/usa/pi_circulars/i/idvynso/idvynso_ppi.pdf.

ⁱ IDVYNSO™ is a trademark of Merck & Co., Inc. BIKTARVY is a registered trademark of Gilead Sciences Ireland UC.

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Versigent Announces First Quarter 2026 Earnings Call and Participation in May Investor Conferences

SCHAFFHAUSEN, Switzerland–(BUSINESS WIRE)–
Versigent PLC (NYSE: VGNT), a global leader in the design and manufacture of low‑ and high‑voltage electrical architectures, today announced that it will release its first quarter 2026 financial results on Tuesday, May 5, 2026, after market close. Versigent will host a conference call to discuss the results at 4:15 p.m. Eastern Time the same day.

The conference call will be hosted by Versigent’s Chief Executive Officer, Joe Liotine, and Chief Financial Officer, Doug Ostermann. A link to the live webcast and presentation materials will be made available on the Versigent Investor Relations website at ir.versigent.com. A replay will be available two hours following the conference call.

To participate by telephone in the Versigent conference call, please dial +1-800-330-6710 (U.S.) or +1-213-279-1505 (International) 15 minutes prior to the start of the call and ask to be connected to the Versigent conference call. The conference ID number is 8379126.

Versigent’s first quarter financial 2026 results will be presented on a carve‑out basis from Aptiv PLC’s historical accounting records, consistent with the financial information included in Versigent’s Registration Statement on Form 10 filed with the U.S. Securities and Exchange Commission pursuant to Section 12(g) of the Securities Exchange Act of 1934, as amended.

Investor Conference Participation

Versigent management will participate in the following investor conferences in May 2026:

Evercore Global Auto Ecosystem Conference

May 13, 2026 — New York City

Deutsche Bank Global Autos, Mobility & Robotics Conference

May 19, 2026 — New York City

Management will participate in a fireside chat, which will be webcast. A link to the webcast will be posted on Versigent’s Investor Relations website.

About Versigent

Versigent is a global leader in the purposeful design and advanced manufacturing of low and high voltage electrical architectures. Building on a legacy of engineering excellence and trusted partnerships, Versigent delivers versatile, intelligent solutions engineered to unlock greater capabilities for our customers. Powering one in six passenger vehicles in production today, Versigent’s high performance signal, power, and data distribution systems are trusted by industry leaders across automotive, commercial vehicles, agriculture and energy storage. With engineering and manufacturing centers on four continents and operations in more than 25 countries, Versigent’s 138,000 employees match global scale with regional responsiveness to deliver consistent quality and reliable performance connecting the world to faster, smarter and safer experiences. Visit www.versigent.com.

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Mastercard Study: Nearly 9 in 10 Consumers in Latin America and the Caribbean Are Ready to Embrace Everyday Digital Payments

• Cash remains relevant where digital acceptance is limited, according to 47% of consumers
• Debit leads everyday payments in LAC, with 60% of consumers using it for daily transactions
• 95% of digital users say security is important when choosing how to pay, reinforcing trust as a key condition for growth

MIAMI–(BUSINESS WIRE)–
A new Mastercard study on the state of digitalization and financial inclusion in Latin America and the Caribbean (LAC) reveals a region entering a new phase of financial progress. Digital participation is now mainstream, but the next phase of financial inclusion – and sustainable, inclusive economic growth – will depend not on access alone, but by how confidently and consistently people and small businesses can use digital payments to manage daily life, grow, plan for the future, and ultimately achieve financial health.

Across LAC, 89% of consumers now qualify as digital users, signaling a significant milestone in the region’s financial and digital evolution. At the same time, momentum continues to build among those still outside the ecosystem, with 68% of non-users saying they are “somewhat or very likely” to adopt digital payments in the future. This reinforces that as adoption scales, the real test of inclusion is shifting from access to everyday usability – the ability to pay, earn, save, and transact with confidence across daily needs, from groceries, and transportation, to services, and other daily necessities wherever life happens.

“Digital participation in Latin America and the Caribbean has reached a new level, and inclusion is no longer just about bringing people into the financial system – it’s about making sure the system works for them every day,” said Andrea Scerch, President, Mastercard Latin America and the Caribbean. “From paying for groceries or a coffee to commuting or managing household expenses, the focus must be on making digital payments work reliably in the moments that matter most.”

Debit: The catalyst for consistent digital lifestyles

Debit has emerged as the region’s most relevant and trusted everyday payment tool, anchoring digital behavior across daily transactions. In fact, debit plays a central role in enabling these everyday transactions, particularly in high-frequency categories:

• Groceries (34%)

• Restaurants and cafés (33%)

• Phone bills (27%)

• Ride-sharing services (26%)

Yet the ability to rely on digital payments consistently remains uneven across the region. In many of these moments – especially in small, local, or informal settings – limited acceptance forces consumers to rely on cash. Closing this gap is essential to improving financial outcomes on both sides of the transaction.

Cash remains stubbornly present in high‑frequency daily moments. Nearly half (47%) of consumers used cash in the past six months. Consumers are clear about what they want next: 87% wish more stores and people accept digital payments, and 59% say that at least once a month they must use cash when they would rather pay with a card or digital device. This acceptance gap represents one of the biggest opportunities in advancing financial inclusion at scale across LAC.

Trust and security are also conditions for growth. Among digital users, 95% say security is important when choosing how to pay and 94% cite trustworthiness as important. For consumers who are hesitant, stronger security features are a key lever: 43% say advanced security would make them more likely to use digital payments, alongside clearer protection in case of problems (38%) and better customer support (36%).

Mastercard’s next commitment: Advancing financial health for people and small businesses

As digital participation expands across the region, Mastercard is evolving its approach to financial inclusion. Building on its long‑standing efforts to expand access, the company is now focused on helping people and small businesses move from access to financial health. Reflecting this shift, Mastercard has committed to connecting and protecting 500 million more people and small businesses on their pathways to financial health by 2030. This commitment recognizes that financial progress is a journey – from making everyday payments and building transaction history to gaining access to tools that help households manage expenses and enable businesses to grow, absorb shocks and plan.

Closing the acceptance gap: Building a secure, frictionless ecosystem for all

Mastercard is focused on closing this gap by expanding digital acceptance in ways that deliver shared value across the region. Through continued collaboration with financial institutions, merchants and governments, Mastercard continues to deliver secure, frictionless payment experiences, such as Contactless, Tap on Phone and Click to Pay, helping merchants of all sizes – from large retailers to neighborhood businesses – accept digital payments easily and securely, meeting consumers where they are.

By reducing friction at checkout, strengthening security, and enabling acceptance in everyday environments, these solutions help ensure that digital payments work reliably across physical and digital touchpoints – supporting local commerce, small businesses, and broader economic participation.

“The inclusion conversation has evolved beyond access. Today, people across the region recognize the benefits of digital payments – speed, convenience and safety,” Scerch added. “That’s why we’re focused not only on expanding acceptance, but on helping people and small businesses participate confidently and safely in the digital economy – whether in large urban centers or local neighborhood businesses. As part of Mastercard’s commitment to connect and protect 500 million more people and small businesses by 2030, we’re working to ensure the benefits of digital payments reach more communities, more consistently, across Latin America and the Caribbean.”

As LAC advances toward a more digital economy, the findings send a clear signal: the future of financial inclusion will depend on how easily people can pay for the things that matter most in their daily lives, wherever they are.

Scope and methodology of research

The study was led by Mastercard and conducted by the independent research agency Many Minds Group. In March 2026, a quantitative online survey was carried out among 3,558 adults across 10 Latin American and Caribbean countries: Argentina, Colombia, Costa Rica, the Dominican Republic, Guatemala, Jamaica, Mexico, Panama, Peru, and Puerto Rico. The sample included banked consumers and/or consumers who use financial services, representing the general online population aged 18 to 55+.

About Mastercard

Mastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we’re building a resilient economy where everyone can prosper. We support a wide range of digital payments choices, making transactions secure, simple, smart and accessible. Our technology and innovation, partnerships and networks combine to deliver a unique set of products and services that help people, businesses and governments realize their greatest potential.

www.mastercard.com

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INDUSTRY KEYWORDS: Personal Finance Technology Payments Other Retail Finance Banking Electronic Commerce Professional Services Small Business Retail

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Adtran and GLDS expand partnership to deliver billing-driven, zero-touch automation for subscriber lifecycle management

News summary:

• Service providers need simpler, billing-integrated automation to streamline activation, manage Wi-Fi and cut operational complexity

• Adtran’s Intellifi^® managed Wi-Fi works with GLDS BroadHub^®, enabling zero-touch automation from order entry through lifecycle management

• Solution reduces operational complexity, accelerates time to revenue and preserves operator control within an open ecosystem

HUNTSVILLE, Ala.–(BUSINESS WIRE)–
Adtran today announced a new phase in its long-standing partnership with GLDS, delivering billing-driven, zero-touch automation for subscriber lifecycle management. As broadband and managed Wi-Fi services scale, manual hand-offs between billing, OSS and in-home networking systems are no longer sustainable. By enabling GLDS BroadHub^® to orchestrate subscriber creation, service activation and ongoing lifecycle changes across access and the connected home, the solution streamlines operations, accelerates time to revenue and reduces operational complexity. This approach gives broadband providers greater control as subscriber expectations rise and service models evolve.

“Our partnership with Adtran is built around a shared goal: making it easier for broadband operators to serve a growing and increasingly demanding customer base,” said Garrick Russell, president and COO of GLDS. “By extending BroadHub^® billing-driven automation all the way through to in-home Wi-Fi, we’re taking the pain out of manual hand-offs that slow activation and increase operational overhead. Operators can manage subscriber onboarding, upgrades and service changes from a single system and apply them consistently across their networks. This means faster onboarding, lower complexity and a more agile operating model that helps providers keep pace with rising customer expectations.”

The new joint solution integrates Adtran’s Intellifi^® managed Wi-Fi platform with the GLDS BroadHub^® system to enable billing-initiated automation across subscriber, service and device lifecycles. Subscriber creation, service activation, configuration updates and device changes are triggered directly from BroadHub^® and applied automatically across access and in-home Wi-Fi environments. This supports zero-touch onboarding, simplifies service changes, and ensures consistent configurations during device replacements or upgrades, including transitions to Wi-Fi 6 and Wi-Fi 7 systems. By aligning billing, service and Wi-Fi workflows through open, standards-based interfaces within a multi-vendor environment, the integration reduces engineering touchpoints, shortens installation cycles and helps providers maintain service continuity as networks and subscriber bases grow.

“This next step in our partnership with GLDS is about empowering service providers to take full control of the entire subscriber journey,” commented Philip Bednarz, GM of software platforms at Adtran. “Wi-Fi is now central to the broadband experience, but it’s also one of the most operationally complex areas to manage at scale. By bringing Intellifi^® into a shared, billing-driven automation framework with GLDS, we’re connecting the in-home experience to the same operational flow that already powers network services – using open interfaces that give providers choice and flexibility, rather than locking them into rigid, closed systems. That removes friction, cuts complexity and delivers true end-to-end control from order placement through ongoing service changes. It offers a more agile model that simplifies operations today and creates a platform ready for tomorrow’s innovation.”

About Adtran

ADTRAN Holdings, Inc. (NASDAQ: ADTN and FSE: QH9) is the parent company of Adtran, Inc., a leading global provider of open, disaggregated networking and communications solutions that enable voice, data, video and internet communications across any network infrastructure. From the cloud edge to the subscriber edge, Adtran empowers communications service providers around the world to manage and scale services that connect people, places and things. Adtran solutions are used by service providers, private enterprises, government organizations and millions of individual users worldwide. ADTRAN Holdings, Inc. is also the majority shareholder of Adtran Networks SE, formerly ADVA Optical Networking SE. Find more at Adtran, LinkedIn and X.

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Wenger and Extru-Tech Unite Under JBT Marel at Petfood Forum 2026

Combined Brands Expand Capabilities; Unveil New Minimally Processed Pet Food Lines

KANSAS CITY, Mo.–(BUSINESS WIRE)–
Wenger and Extru-Tech, both global leaders in pet and human food extrusion processing solutions, will exhibit at Petfood Forum in Kansas City on April 27-29, 2026, at Booth #1614. This marks the first time both brands will come together in one booth for the industry’s largest gathering of pet food professionals in North America.

This union marks a new chapter as these trusted brands unite under JBT Marel to drive greater innovation and expand product offerings – all in pursuit of a shared goal to transform the future of pet food processing.

“The 2026 Petfood Forum is the physical realization of our mission to be ‘Stronger Together’,” said Travis Moore, General Manager of Wenger and Extru-Tech. “We bring more than 90 years of Wenger and Extru-Tech extrusion and processing solutions expertise together with JBT Marel’s significant strengths in meat preparation, forming, high pressure processing, and steam tunnel gentle-cooking equipment to offer the most comprehensive pet food offerings in the industry. As a unified partner, we make pet food more sustainable, safe, and nutritious.”

The centerpiece of the exhibit is the recently launched Minimally Processed Pet Food Line solutions. This breakthrough system redefines traditional kibble, premium kibble, “un-kibble,” and treats. It meets the growing demand for holistic nutrition, which focuses on natural, nutrient-dense, and highly digestible products. Attendees will see a complete, minimally processed line in action in a new virtual immersive space, giving them an end-to-end look at the process and equipment.

The line supports a diverse range of minimally processed categories, including gently cooked, air-dried, fresh, and baked applications. Key standouts at the booth will include:

• PetFlex Extrusion: The most versatile twin-screw technology to date. Wenger’s PetFlex extruder allows processors to swap between traditional recipes and high-fresh-meat inclusions on the same hardware. This enables the production of personalized, allergy-friendly, and sustainable pet foods without the need for extensive hardware changes.
• High Pressure Processing (HPP): JBT Marel’s HPP machines utilize ultra-high-pressure purified water to keep raw pet food free of pathogens and fresh longer.
• Integrated Steam Tunnel: This thermal processing equipment uses steam tunnel technology for gentle cooking, leading to higher nutritional integrity and natural-looking chunks required for premium holistic diets.

Attendees are invited to visit the combined Wenger and Extru-Tech booth (#1614) and speak with business development managers, engineers and leadership from all brands.

About JBT Marel

JBT Marel Corporation (NYSE and Nasdaq Iceland: JBTM) is a leading global technology solutions provider to high-value segments of the food & beverage industry. JBT Marel’s unique solutions of integrated equipment, service, software, and application expertise enables customers to optimize food yield and efficiency, improve food safety and quality, and enhance uptime and proactive maintenance, all while reducing waste and resource use across the global food supply chain. JBT Marel operates more than 50 manufacturing and distribution facilities globally. For more information, please visit www.jbtmarel.com.

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Corcept to Present New Data from Pivotal Phase 3 ROSELLA Trial of Lifyorli™ (Relacorilant) in Patients with Platinum-Resistant Ovarian Cancer at ASCO 2026

REDWOOD CITY, Calif.–(BUSINESS WIRE)–
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, will present new data from its pivotal Phase 3 ROSELLA trial of Lifyorli™ (relacorilant) plus nab-paclitaxel in platinum-resistant ovarian cancer at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The data will be presented in an oral presentation on Friday, May 29, 2026.

Overall survival subgroup analyses for prior taxane use in the phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72, APGOT-Ov10, LACOG-0223, and ANZGOG-2221/2023)

• Oral Abstract Session – Gynecologic Cancer

• May 29, 2026, 2:45 PM – 5:45 PM CDT

• Abstract Number: 5503

Lifyorli, in combination with nab-paclitaxel, was approved by the U.S. Food and Drug Administration (FDA) in March 2026 for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. Lifyorli is the first FDA-approved selective glucocorticoid receptor antagonist (SGRA). It is included in the National Comprehensive Cancer Network^® Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) as a preferred regimen for patients with platinum-resistant ovarian cancer.

The ROSELLA trial was conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG).

About Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have “platinum-resistant” disease. There are few treatment options for these women. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

About Cortisol’s Role in Oncology

Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenic signaling in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including cancer.

Corcept is developing relacorilant in ovarian, endometrial, cervical, pancreatic and prostate cancers. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the European Commission (EC) for the treatment of ovarian cancer. Corcept has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.

About Lifyorli™

Lifyorli (relacorilant), approved in combination with nab-paclitaxel, is the first U.S. Food and Drug Administration (FDA)-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Lifyorli is an oral medication taken the day before, the day of and the day after treatment with nab-paclitaxel. There is no biomarker requirement to receive Lifyorli. Lifyorli competitively binds to the glucocorticoid receptor (GR), where it enhances chemotherapy sensitivity by inhibiting cortisol’s suppression of apoptosis – the programmed cell death that chemotherapies such as nab-paclitaxel are meant to cause. Lifyorli does not have any effect at the body’s other steroid receptors.

It is included in the National Comprehensive Cancer Network^® Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) as a preferred regimen for patients with platinum-resistant ovarian cancer.

Corcept is committed to timely patient access for Lifyorli. For questions regarding product availability, please contact Lifyorli Support™ at 1-85-LIFYORLI (1-855-439-6754).

LIFYORLI Indication & Usage

LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic treatment regimens, at least one of which included bevacizumab.

IMPORTANT SAFETY INFORMATION

Contraindications:

LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because LIFYORLI antagonizes the effect of glucocorticoids.

Warnings and Precautions:

Neutropenia and Severe Infections

LIFYORLI in combination with nab-paclitaxel can cause neutropenia, including febrile neutropenia and severe infections. There was one fatal event of septic shock with febrile neutropenia. Thirty-eight percent of patients initiated granulocyte colony-stimulating factor(G-CSF) during the first or second cycle of therapy.

Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated. Based on the severity of neutropenia, delay dose, reduce dose or permanently discontinue LIFYORLI in combination with nab-paclitaxel. Consider short-acting G-CSF administration as applicable. Consider the possibility of concurrent adrenal insufficiency, particularly in the setting of serious infection.

Adrenal Insufficiency

LIFYORLIis a reversible glucocorticoid receptor antagonist and can cause adrenal insufficiency. Adrenal insufficiency can occur at any time during treatment with LIFYORLI. The risk of adrenal insufficiency is increased in situations of stress, such as acute illness, infection, or surgery. Consider whether supplemental glucocorticoids are required in the perioperative period in patients who have received LIFYORLI within 30 days of surgery. Monitor patients receiving LIFYORLI for signs and symptoms of adrenal insufficiency. Withhold LIFYORLI and administer glucocorticoid therapy if adrenal insufficiency is suspected. High doses of supplemental glucocorticoids may be needed to overcome the glucocorticoid receptor antagonism produced by LIFYORLI. After resolution of adrenal insufficiency, resume previous dose, reduce dose or permanently discontinue LIFYORLI based on severity.

Exacerbation of Conditions Treated with Glucocorticoids

Use of LIFYORLI in patients taking systemic glucocorticoids for other conditions (e.g., autoimmune disorders) may exacerbate these conditions. LIFYORLI is a glucocorticoid receptor antagonist that may make systemic glucocorticoids less effective. Similarly, coadministration of systemic glucocorticoids may make LIFYORLI less effective. Monitor patients for reduced effectiveness of LIFYORLI and glucocorticoids in patients receiving both.

Embryo-Fetal Toxicity

LIFYORLI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating LIFYORLI treatment. Advise females of reproductive potential, including male patients with female partners of reproductive potential, to use effective contraception during treatment with LIFYORLI and for 1 week after the last dose.

Adverse Reactions:

Serious adverse reactions occurred in 35% of patients who received LIFYORLI in combination with nab-paclitaxel. Serious adverse reactions (≥2%) in patients were neutropenia (4%), pneumonia (3.2%), pleural effusion (3.2%), febrile neutropenia (2.1%), and fatigue (2.1%). Fatal adverse reactions (2.1%) in patients were septic shock (0.5%), cardiac arrest (0.5%), ischemic stroke (0.5%), and intestinal perforation (0.5%).

Permanent discontinuation of LIFYORLI in combination with nab-paclitaxel due to adverse reactions occurred in 9% of patients. The adverse reaction (>2%) that resulted in permanent discontinuation of LIFYORLI in patients was intestinal obstruction (2.6%). Dosage interruptions of LIFYORLI due to an adverse reaction occurred in 72% of patients. Adverse reactions (≥5%) that required dosage interruptions of LIFYORLI in combination with nab-paclitaxel in patients included neutropenia (44%), anemia (12%), and fatigue (7%). Adverse reactions requiring dose reductions of LIFYORLI included fatigue (1.6%), decreased appetite (1.2%), abdominal pain (0.5%), neutropenia (0.5%), edema (0.5%), and sciatica (0.5%). LIFYORLI should be interrupted or discontinued when nab-paclitaxel is interrupted or discontinued.

The most common adverse reactions (>20%) of patients treated with LIFYORLI plus nab-paclitaxel, including laboratory abnormalities, were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.

Drug Interactions:

• Strong CYP3A Inducers: Avoid coadministration of LIFYORLI plus nab-paclitaxel with strong CYP3A inducers. Both relacorilant and paclitaxel are CYP3A substrates. Coadministration of strong CYP3A inducers can decrease concentrations of relacorilant and paclitaxel, which may reduce their effectiveness.
• CYP2C8 and Moderate CYP3A Inducers: Monitor for reduced effectiveness of LIFYORLI plus nab-paclitaxel with CYP2C8 inducers and moderate CYP3A inducers. Paclitaxel is a substrate of CYP2C8 and CYP3A, and relacorilant is a CYP3A substrate. Coadministration of CYP2C8 and moderate CYP3A inducers can decrease concentrations of paclitaxel and relacorilant, which may reduce their effectiveness.
• CYP2C8 Inhibitors: Monitor for increased adverse reactions and modify the dosage for adverse reactions as recommended.Paclitaxel is a substrate of CYP2C8. Coadministration of CYP2C8 inhibitors may increase concentrations of paclitaxel, which may increase the risk of adverse reactions.
• CYP3A Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A substrates. Relacorilant is a strong CYP3A inhibitor. Relacorilant increases exposure of CYP3A substrates which may increase the risk for adverse reactions related to these substrates.
• Certain CYP2C8 Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP2C8 substrates where minimal concentration changes may lead to reduced effectiveness. Relacorilant is a weak CYP2C8 inducer. Relacorilant decreases exposure of CYP2C8 substrates which may decrease the effectiveness related to these substrates.

Use in Specific Populations:

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

• Geriatric Use: A higher incidence of grade 3-4 adverse events and dosage modification occurred in patients aged ≥65 years compared to younger adult patients.

• Hepatic Impairment: Avoid LIFYORLI in combination with nab-paclitaxel in patients with moderate or severe hepatic impairment (total bilirubin >1.5 to 10x ULN and any AST).

Please see the full Prescribing Informationfor additional Important Safety Information.

About Corcept Therapeutics

For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with Cushing’s syndrome, solid tumors, ALS and liver disease. In 2012, the company introduced Korlym^®, the first medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with endogenous Cushing’s syndrome, and in 2026, the company introduced Lifyorli™, approved in combination with nab-paclitaxel, the first FDA-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com.

Forward-Looking Statements

Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from any future results expressed or implied by such forward-looking statements.

In this press release, forward-looking statements include statements concerning: Lifyorli’s efficacy, safety profile and other clinical attributes; presentation of the data from the Phase 3 ROSELLA trial at the ASCO meeting; the incidence of platinum-resistant ovarian cancer patients expected to start a new therapy each year in the United States and Europe; our further development of relacorilant in ovarian, endometrial, cervical, pancreatic and prostate cancers; and our commitment to timely patient access for Lifyorli.

A further description of risks and uncertainties can be found in our SEC filings, which are available at our website and the SEC’s website. These risks and uncertainties include, but are not limited to, those related to: our ability to operate our business; our efforts to study and develop Korlym, relacorilant, miricorilant, dazucorilant, nenocorilant and our other product candidates; those molecules’ clinical attributes; regulatory approvals, mandates, oversight and other requirements imposed on our products or our business by laws, regulations or discretion of government authorities; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.

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