Archives May 2026

Business Wire India

 

Takeda (TSE:4502/NYSE:TAK) today announced that TAK-881-3001, a pivotal Phase 2/3 clinical trial in patients with Primary Immunodeficiency Disease (PID), met its primary endpoint, which demonstrated pharmacokinetic (PK) comparability between the investigational TAK-881 [Immune Globulin Subcutaneous (Human), 20% Solution (SCIG 20%) with Recombinant Human Hyaluronidase] and HYQVIA [Immune Globulin Infusion (Human) 10% with Recombinant Human Hyaluronidase]. Additionally, secondary endpoints showed that TAK-881, a SCIG 20% facilitated with hyaluronidase, demonstrated safety, efficacy and tolerability profiles comparable to HYQVIA, an established SCIG 10% facilitated with hyaluronidase. These findings support the potential of TAK-881 to deliver the required immunoglobulin (IG) dose for PID patients in half the volume of HYQVIA, reducing infusion duration while maintaining flexible, up to once-monthly dosing for patients (every three or four weeks for PID).

 

The TAK-881-3001 clinical trial evaluated the PK, efficacy, safety, tolerability and immunogenicity of TAK-881 in adults and pediatric patients aged 2 years and older with PID previously treated with IG therapy and compared them with HYQVIA in patients aged 16 years and older. Initial topline data show TAK-881:

 

 

• Achieved comparable PK: The study met its primary endpoint demonstrating equivalent immunoglobulin G (IgG) exposure between TAK-881 and HYQVIA as shown by a geometric mean ratio of 99.67% (90% CI: 95.10% to 104.46%) for the areas under the concentration-time profiles over one dosing interval at the steady state (AUC_0-tau,ss).
• Provided immune protection: TAK‑881 demonstrated comparable infection rates and immune protection to HYQVIA, with protective IgG levels consistently maintained throughout the study.
• Demonstrated a comparable safety profile: The safety and tolerability profiles of TAK-881 shown were comparable to HYQVIA, with no new safety signals observed. The safety profile of TAK-881 will continue to be evaluated in the ongoing TAK-881-3002 extension study.

 

 

“These Phase 2/3 results showed the pharmacokinetic profile of TAK-881 was comparable to HYQVIA, an established IG standard of care in patients with PID, while offering the potential advantages of fewer injection sites, a flexible treatment schedule and shorter infusion times,” said Kristina Allikmets, MD, PhD, Senior Vice President and Head of Plasma Derived Therapies R&D at Takeda. “TAK-881-3001 reflects our broader R&D commitment to advancing next-generation IG therapies and bringing meaningful new treatment options to patients faster, while expanding patient choice and upholding rigorous standards of efficacy and safety.”

 

For many patients with PID, IG replacement is the only treatment option to maintain immune protection against infections. While existing IG therapies are effective, many patients continue to experience treatment burden, including frequent or high-volume infusions.

 

 

“Patients needing lifelong IG therapy for PID experience a significant burden of care. Improving the administration process can diminish the burden of care by substantively impacting the treatment experience,” said Richard L. Wasserman, MD, PhD, allergist/immunologist and principal investigator for TAK-881-3001. “These topline results from TAK-881-3001 are encouraging. They show that a highly concentrated, hyaluronidase-facilitated subcutaneous IG can provide immune protection with a more manageable infusion experience intended to enhance the day-to-day lives of patients living with PID.”

 

 

Analyses from TAK-881-3001 are ongoing, and Takeda anticipates sharing additional results in an upcoming medical forum. Takeda expects to submit applications for TAK-881 to regulatory authorities in the United States, European Union and Japan in fiscal year 2026.

 

 

About TAK-881-3001 and TAK-881-3002

 

 

TAK-881-3001 was a pivotal Phase 2/3 clinical trial evaluating the pharmacokinetics, efficacy, safety, tolerability and immunogenicity of TAK-881 in adults and pediatric patients aged 2 years and older with Primary Immunodeficiency Disease (PID) who were previously treated with immunoglobulin (IG) therapy. Study participants aged 16 and older were randomized to be treated with TAK-881 followed by HYQVIA or HYQVIA followed by TAK-881 with the same dose and dosing interval of IG for up to 51 weeks in the open label, randomized cross-over study part. Participants aged 2 to < 16 were treated with only TAK-881 for up to 27 weeks in the open label single-arm study part. Further information about the TAK-881-3001 clinical trial is available at ClinicalTrials.gov under study identifier NCT05755035.

 

 

TAK-881-3002 is a Phase 3 study evaluating the long-term safety and tolerability of TAK-881 in patients with PID and is the extension study of TAK-881-3001. Further information about the TAK-881-3002 clinical trial is available at ClinicalTrials.gov under study identifier NCT06076642.

 

 

About TAK-881

 

 

TAK-881 [Immune Globulin Subcutaneous (Human), 20% Solution (SCIG 20%) and Recombinant Human Hyaluronidase] is an investigational liquid medicine comprised of one vial of immunoglobulin (IG) 20% and one vial of Halozyme’s recombinant human hyaluronidase (rHuPH20). IG is collected from human plasma and maintains the body’s immune system. TAK-881 is infused under the skin into the fatty subcutaneous tissue where the hyaluronidase facilitates the dispersion and increases the absorption of immunoglobulin in the subcutaneous tissue, allowing larger volumes to be infused at a given infusion site. As a SCIG 20% facilitated with hyaluronidase, TAK-881 is being developed with the goal of reducing infusion volume and duration while providing effective immune protection for patients with PID.

 

 

About Primary Immunodeficiency Disease (PID)

 

 

Primary Immunodeficiency Disease (PID) is a group of more than 550 rare and chronic disorders, where a part of the body’s immune system is missing or does not function the way it should.¹ These conditions result from genetic mutations, which are usually inherited.² The symptoms of PID vary and can include frequent and/or persistent infections and unusual autoimmunity, often leading to prolonged periods of misdiagnosis despite consultations with multiple specialists.³ In the United States, PID affects about 1 in 1,200 people.⁴

 

 

About HYQVIA®

 

 

HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is a liquid medicine containing immunoglobulin (IG) 10% and Halozyme’s recombinant human hyaluronidase (rHuPH20). HYQVIA is approved by the European Medicines Agency (EMA) as a replacement therapy in adults, children and adolescents (0-18 years) with Primary Immunodeficiency Disease (PID) with impaired antibody protection and with Secondary Immunodeficiency Disease (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment, and either proven specific antibody failure (PSAF) or serum IgG level of <4 g/L. In addition, it is approved by the EMA in adults, children and adolescents (0-18 years) with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous IG therapy (IVIG).

 

 

In the United States HYQVIA is approvedto treat adults and children two years of age and older with PID as a well as a maintenance therapy for adult patients with CIDP.

 

 

HYQVIA is infused under the skin into the fatty subcutaneous tissue and contains IG collected from human plasma. IGs are antibodies that maintain the body’s immune system. The hyaluronidase part of HYQVIA facilitates the dispersion and absorption of IG in the subcutaneous space between the skin and the muscle. HYQVIA is infused up to once a month (every two, three or four weeks for CIDP; every three or four weeks for PID).

 

 

HyQvia® (Human normal immunoglobulin) 100 mg/ml solution for infusion for subcutaneous use

 

 

Important Safety Information (European Union)

 

 

Please consult the HyQvia (Human normal immunoglobulin (SCIg)) Summary of Product Characteristics (SmPC) before prescribing, particularly in relation to dosing and treatment monitoring.

 

 

GUIDANCE FOR USE: Therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency/CIDP. The medicinal product should be administered via the subcutaneous (SC) route. The dose and dose regimens are dependent on the indication. The dose may need to be individualized for each patient dependent on the PK and clinical response. Dose based on bodyweight may require adjustment in underweight or overweight patients.

 

 

CONTRAINDICATIONS: Not be given intravenously or intramuscularly. Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to human immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA. Systemic hypersensitivity to hyaluronidase or rHuPH20.

 

 

SPECIAL POPULATIONS: Paediatric population: The dosing schedule for children and adolescents (0 to 18 years) for replacement and immunomodulatory therapies is the same as for adults. The warnings and precautions listed in the SmPC apply both to adults and children. Pregnancy: the safety of this medicinal product for use in human pregnancy has not been established in controlled clinical studies and therefore should only be given with caution to pregnant women and breast-feeding mothers. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected. Fertility: there are currently no clinical safety data available. Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.

 

 

SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Traceability: in order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Precautions for use: if HyQvia is accidentally administered into a blood vessel, patients could develop shock; Certain adverse reactions may occur more frequently in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion; potential complications can often be avoided by initially infusing the product slowly and ensuring that patients are carefully monitored. All other patients should be observed for at least 20 minutes after the administration. When treatment is given at home, support from another responsible person should be available. Patients on self-home treatment and/or their guardian should also be trained to detect early signs of hypersensitivity. In case of adverse reaction, either the rate of administration must be reduced, or the infusion stopped. No chronic changes in the skin were observed in the clinical studies. Patients should be reminded to report any chronic inflammation, nodules or inflammation that occurs at the infusion site and lasts more than a few days. Hypersensitivity to IG 10%:Patients with anti-IgA antibodies, in whom treatment with SCIg products remains the only option, should be treated with HyQvia only under close medical supervision. Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin, please read the SmPC for more information. Hypersensitivity to rHuPH20: any suspicion of allergic or anaphylactic like reactions following rHuPH20 administration requires immediate discontinuation of the infusion and standard medical treatment should be administered, if necessary. Immunogenicity of rHuPH20: development of non-neutralizing antibodies and neutralizing antibodies to the rHuPH20 component has been reported in patients receiving HyQvia in clinical studies. Arterial and venous thromboembolic events have been associated with the use of immunoglobulins. Patients should be sufficiently hydrated before using immunoglobulins. Caution should be exercised in patients with pre-existing risk factors for thromboembolic events. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Thrombosis may also occur in the absence of known risk factors. Patients should be informed about first symptoms of thromboembolic events and be advised to contact their physician immediately upon onset of symptom. Haemolytic anaemia: immunoglobulin products contain antibodies to blood groups (e.g. A, B, D) which may act as haemolysins. Immunoglobulin product recipients should be monitored for clinical signs and symptoms of haemolysis. Aseptic meningitis syndrome (AMS): it has been reported to occur in association with IVIg and SCIg treatment; the symptoms usually begin within several hours to 2 days following immunoglobulin treatment. Patients should be informed about the first symptoms. Discontinuation of immunoglobulin treatment may result in remission of AMS within several days without sequelae. AMS may occur more frequently in association with high-dose (2 g/kg) IVIg treatment. From post-marketing data no clear correlation of AMS to higher doses was observed. Higher incidences of AMS were seen in women. Interference with serological testing: After infusion of immunoglobulins, the transitory rise of the various passively transferred antibodies in the patient’s blood may result in misleading positive results in serological testing. Infusions of immunoglobulin products may lead to false positive readings in assays that depend on detection of β-D-glucans for diagnosis of fungal infections. Transmissible agents: standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens. The measures taken are considered effective for enveloped and for the non-enveloped viruses.

 

 

INTERACTIONS: Live attenuated virus vaccines Immunoglobulin administration may impair for a period of at least 6-weeks and up to 3-months the efficacy of live attenuated virus vaccines. After administration of this medicinal product, an interval of 3-months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 1 year. Therefore, patients receiving measles vaccine should have their antibody status checked.

 

 

UNDESIRABLE EFFECTS: The most frequently reported adverse reactions (Ars) were local reactions. The most frequently reported systemic Ars were headache, fatigue, nausea, and pyrexia. The majority of these Ars were mild to moderate. Cases of transient aseptic meningitis, transient haemolytic reactions, increase in serum creatinine level and/or acute renal failure have been observed with human normal immunoglobulin. ADRs frequency per infusion: very common (≥ 1/10): Local reactions (Total, see SmPC for the detailed list of local reactions); common (≥ 1/100 to < 1/10): Headache, Nausea, Abdominal pain, Abdominal pain lower, Abdominal pain upper and Abdominal tenderness, Erythema, Asthenia, Fatigue, Lethargy and Malaise; uncommon (≥ 1/1 000 to < 1/100): Dizziness, Migraine, Tremor, Paraesthesia, Sinus tachycardia and Tachycardia, Blood pressure increased and Hypertension, Diarrhoea, Vomiting, Abdominal distension, Pruritus, Rash, Rash erythematous, Rash macular, Rash maculo-papular and Rash papula, Urticaria, Myalgia, Arthralgia, Limb discomfort and Pain in extremity Back pain, Joint stiffness, Musculoskeletal chest pain, Chills, Oedema, Oedema peripheral and Swelling (systemic), Localised oedema, Peripheral swelling and Skin oedema, Gravitational oedema, Oedema genital, Scrotal swelling and Vulvovaginal swelling, Burning sensation; rare (≥ 1/10 000 to < 1/1 000): Cerebrovascular accident and Ischaemic stroke, Hypotension, Dyspnoea, Groin pain, Haemosiderinuria, Hyperhidrosis, Coombs direct test positive and Coombs test positive.

 

 

For EU SmPC, please visit: https://www.ema.europa.eu/en/documents/product-information/hyqvia-epar-product-information_en.pdf

 

 

For U.S. full Prescribing Information, please visit: https://www.shirecontent.com/PI/PDFs/HYQVIA_USA_ENG.pdf

 

 

About Takeda

 

 

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

 

 

Important Notice

 

 

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

 

 

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

 

 

Forward-Looking Statements

 

 

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

 

 

Medical Information

 

 

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

 

 

1 Immune Deficiency Foundation. Living With Primary Immunodeficiency. Accessed April 2026. Available at: https://primaryimmune.org/living-primary-immunodeficiency.
2 Center for Disease Control and Prevention. About Primary Immunodeficiency (PI). Accessed April 2026. Available at: https://www.cdc.gov/primary-immunodeficiency/about/index.html.
3 Immune Deficiency Foundation. Understanding Primary Immunodeficiency. Accessed April 2026. Available at: https://primaryimmune.org/understanding-primary-immunodeficiency.
4 Kobrynski L, Powell RW, Bowen S. J Clin Immunol. 2014;34(8):954-961

 

 

 

 

 

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Business Wire India

 

Andersen Global advances its growth across Africa with the addition of Andersen in Namibia, as Windhoek Advisory & Taxation adopts the Andersen brand, strengthening its ability to serve businesses operating in one of southern Africa’s dynamic emerging markets.

 

A collaborating firm since 2021, Andersen in Namibia is a locally owned professional services firm delivering accounting, tax, and business advisory services tailored to the unique needs of Namibia’s business environment. With expertise spanning mining, agriculture, logistics, tourism, and financial services, sectors critical to Namibia’s economy, the firm supports both domestic enterprises and international businesses establishing operations in the region. Through cloud-based technology and data-driven insights, Andersen in Namibia delivers efficient, scalable solutions that enable businesses to optimize operations, manage tax obligations across jurisdictions, and make informed strategic decisions.

 

 

“Our transition to the Andersen brand represents a significant milestone for our firm and for the businesses we serve across Namibia,” said Managing Partner Bernadedt Kandenge. “We have built our practice around ethical integrity, collaboration, and a deep understanding of the challenges and opportunities facing Namibian enterprises. Becoming a member firm strengthens our ability to support businesses with scalable, cross-border solutions while maintaining the personalized, locally-informed service our clients value.”

 

 

“This transition builds on a successful collaboration and represents an important step in our long-term strategy in Africa,” said Mark L. Vorsatz, global chairman and CEO of Andersen. “Bernadedt and her team enhance our capabilities to serve businesses in Namibia and throughout the region, and reinforce our ability to deliver consistent, high-quality service that addresses both local requirements and global standards.”

 

 

Andersen Global is an international association of legally separate, independent member firms comprised of tax, legal, and valuation professionals around the world. Established in 2013 by U.S. member firm Andersen Tax LLC, Andersen Global now has more than 50,000 professionals worldwide and a presence in over 1,000 locations through its member firms and collaborating firms.

 

 

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260508917653/en/

 

Business Wire India

 

Verdantis today announced the global launch of MRO360, a purpose-built AI platform that transforms how asset-intensive organizations manage their MRO spare parts inventory. Designed for manufacturers, oil and gas operators, mining companies, utilities, and other industrial enterprises, MRO360 deploys nine interconnected AI agents that continuously forecast demand, score parts criticality, manage obsolescence risk, calculate dynamic reorder points, helps intercompany plant transfer thereby realizing the exact dollar value of every optimization opportunity across a spare parts catalog in real time.

 

Unlike traditional EAM and CMMS platforms built on static rules, MRO360’s agents adapt continuously as demand patterns, supplier performance, and equipment health evolve. For the first time, a maintenance planner can see which work orders are at supply risk today and what to do about it. A CFO can see a live dollar figure of releasable excess inventory.

 

 

“We have spent over twenty years working inside the data of asset-intensive industries. We know where the value lies, how supplier relationships are managed by gut feel rather than predictive intelligence and how maintenance plans do not take in account what is on the shelf. MRO360 is our answer to that. It is the foundation layer of something much larger- the industry’s first Enterprise Asset Management solution, where every capability is designed as an intelligent agent that learns and adapts. This is where that journey begins.

 

 

– Kumar Gaurav Gupta, CEO, Verdantis

 

 

MRO360 is the foundation of a broader and deliberate vision. Verdantis is building toward what the industry has never had: a fully AI-native Enterprise Asset Management solution spanning all six EAM domains- from spare parts intelligence to asset lifecycle management, maintenance execution, workforce planning, procurement, and compliance, each module an AI agent built from the ground up. MRO360 establishes the core. The roadmap ahead extends that intelligence progressively across the full asset management lifecycle.

 

 

About Verdantis: Verdantis is a global AI software company with over two decades of experience delivering data intelligence and operational optimization for asset-intensive industries.

 

 

Headquartered in Princeton New Jersey with operations across North America, the Middle East, Europe, and Asia-Pacific. www.verdantis.com/mro360

 

 

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260507550148/en/

 

Business Wire India

• Significant unmet need remains for 85% of lupus patients whose disease includes skin manifestations, often associated with substantial physical and psychosocial burden
• Enpatoran, an oral TLR7/8 inhibitor, is designed for lupus patients with active cutaneous manifestations, with the goal of broadening the treatment paradigm beyond the current standards
• ELOWEN is a global Phase 3 program evaluating enpatoran’s impact on both skin and systemic symptoms in patients with lupus and potential links between skin and systemic disease activity

 

Merck, a leading global science and technology company, today announced the first patient was dosed in the Phase 3 program, ELOWEN-1 (NCT07332481) and ELOWEN-2 (NCT07355218), evaluating enpatoran in people living with lupus who experience active skin manifestations.

 

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260430733656/en/

 

 

 

“People living with lupus continue to face significant challenges in achieving disease control and are very often affected by itchy, painful and stigmatized skin manifestations,” said David Weinreich, Global Head of R&D, Merck. “With enpatoran, we aim to target the underlying drivers of lupus and redefine how to approach the disease by understanding both visible skin manifestations and systemic activity.”

 

Enpatoran is an oral selective toll-like receptor (TLR) 7/8 inhibitor designed to modulate pathways central to lupus-related inflammation.¹ By targeting these upstream drivers, enpatoran has the potential to impact disease activity and address a key aspect of the lupus mechanism that remains difficult to manage with current treatment approaches, while preserving the body’s broader immune function.¹

 

 

“The ELOWEN program builds on Phase 2 findings, where enpatoran demonstrated clinically meaningful improvements in patients with active cutaneous manifestations, regardless of their underlying lupus diagnosis,” said Professor Eric Morand, principal investigator. “These studies are designed to further explore how targeting shared inflammatory pathways may benefit patients across the lupus spectrum.”

 

 

Lupus is a chronic autoimmune disease that can affect multiple organ systems, including the skin, joints, kidneys and central nervous system.² Up to 85% of patients experience skin manifestations, which are among the most visible signs of disease and may reflect underlying immune-driven inflammation.¹

 

 

Skin manifestations can be life-altering and sometimes are irreversible on their own.^3,4 They can present as inflamed, photosensitive lesions on the face, scalp and other areas, and may lead to scarring or pigment changes.⁵ Despite their prevalence and the fact that skin manifestations are the first sign of disease in nearly one third (29%) of cases,¹ many patients still do not achieve adequate disease control.⁶

 

 

“Skin symptoms impose a profound and multilayered burden that lingers long after flares subside. The lesions are visible, disfiguring and often painful, and the psychological weight can be equally debilitating, breeding a loss of identity that standard clinical assessments often fail to capture,” said Dr. Joy Buie, PhD, VP of Research at the Lupus Foundation of America. “These consequences erode participation in work, social life, and intimate relationships as self-consciousness and deliberate avoidance quietly reshape how patients navigate the world around them. It is vital we recognize skin manifestations as a visible and clinically actionable signal of underlying systemic disease “

 

 

ELOWEN-1 and ELOWEN-2 are two global randomized, double-blind, placebo-controlled Phase 3 studies evaluating enpatoran taken twice daily versus placebo, on top of standard of care, in patients with lupus who have active cutaneous manifestations. The ELOWEN studies will be conducted in 266 sites in 26 countries. Each study will recruit approximately 200 lupus participants, and the primary endpoint will be a change in CLASI-A from baseline.

 

 

About Enpatoran

 

 

Enpatoran is an investigational, oral, selective inhibitor of toll-like receptors 7 and 8 (TLR7/8), which play a key role in immune pathways involved in lupus. Enpatoran has the potential to be the first targeted therapy for lupus patients with active cutaneous manifestations, with the goal of broadening the treatment paradigm beyond the current standards of care for patients with CLE and SLE.

 

 

Enpatoran is currently under clinical investigation and has not been approved for any use anywhere in the world.

 

 

About the Phase 3 ELOWEN Program

 

 

ELOWEN-1 (NCT07332481) and ELOWEN-2 (NCT07355218) are two global randomized, double-blind, placebo-controlled Phase 3 studies evaluating enpatoran taken twice daily versus placebo, on top of standard of care, in patients with lupus who have active cutaneous manifestations. The ELOWEN studies will be conducted in 266 sites in 26 countries. Each study will recruit approximately 200 lupus participants, and the primary endpoint will be a change in CLASI-A from baseline.

 

 

About Lupus Erythematosus

 

 

Lupus erythematosus is a chronic autoimmune disease characterized by inflammation that can affect multiple organs and systems in the body. The disease is heterogeneous, with symptoms ranging from mild to life-threatening, and often follows a relapsing-remitting course.

 

 

Cutaneous manifestations are common (72-85%) of patients and can occur alongside or independently of systemic involvement. Beyond their physical presentation, they are associated with increased disease burden, including scarring, psychological impact and reduced quality of life.

 

 

Lupus disproportionately affects women and people of color, and many patients continue to experience unmet medical needs due to insufficient disease control or treatment-related side effects.

 

 

Merck in Neurology and Immunology

 

 

Merck has a long-standing legacy in neurology and immunology. The company’s current neurology portfolio includes two products for the treatment of relapsing MS – Rebif^® (interferon beta-1a) and MAVENCLAD^® (cladribine) tablets. Merck aims to improve the lives of patients by addressing areas of unmet medical needs. In addition to Merck’s commitment to MS, the company also has a pipeline focusing on discovering new therapies that have potential in other neuroinflammatory and immune-mediated diseases, including lupus and generalized myasthenia gravis (gMG).

 

 

About Merck

 

 

Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2025, Merck generated sales of € 21.1 billion in 65 countries.

 

 

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics.

 

 

All Merck press releases are distributed by e-mail at the same time they become available on the Merck website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

 

 

1 Childs B and Merola JF. From the Masterclasses in Dermatology 2025 Meeting: Practical Approaches to Cutaneous and Systemic Lupus for Dermatologists. J Clin Aesthet Dermatol. 2025;18(10):40–47.

2 Lupus Research Alliance. What Is Lupus? Available at: https://www.lupusresearch.org/about-lupus/what-is-lupus/. Last accessed: April 2026.

3 Klein R, Moghadam-Kia S, Taylor L, et al. Quality of Life in Cutaneous Lupus Erythematosus. J Am Acad Dermatol. 2011 Mar 12;64(5):849–858.

4 Chambers S, On A, Yang X, et al. Dyspigmentation and scarring in cutaneous lupus erythematosus. Lupus Sci Med. 2025;12(2).

5 Lupus Foundation of America. What is lupus? Available at: https://www.lupus.org/resources/what-is-lupus. Last accessed: April 2026.

6 Kandane-Rathnayake, Louthrenoo W, Hoi A, et al. ‘Not at target’: prevalence and consequences of inadequate disease control in systemic lupus erythematosus—a multinational observational cohort study. Arthritis Res Ther. 2022;24:70.

 

 

 

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260430733656/en/

 

Business Wire India

SS&C Technologies Holdings, Inc. (Nasdaq: SSNC) today announced the launch of SS&C Blue Prism WorkHQ, its agentic automation platform designed to help enterprises operationalize agentic AI safely, transparently and with full control of end-to-end workflows.

 

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260429512507/en/

 

 

Unveiled at a live event at Nasdaq in New York City, WorkHQ introduces a unified control plane orchestrating people, AI agents, APIs and digital workers into a single governed environment.

 

 

SS&C developed WorkHQ based on its own experience operating at scale across regulated industries. Today, SS&C supports more than 23,000 customers globally with the help of 4,000+ digital workers and more than 50 AI agents. These efforts have enabled SS&C to significantly improve operational efficiency in key processes, reducing processing times by up to 95% in key workflows.

 

 

“WorkHQ was built for the enterprise problem, not the enterprise demo. Most organizations deploying AI today are navigating hundreds of systems, legacy infrastructure, and compliance requirements that don’t bend to accommodate new technology. We designed WorkHQ for that reality from the ground up,” said Rob Stone, General Manager, Intelligent Automation & Analytics. “We had an advantage of deploying the platform inside a large, complex, regulated operation before it ever reached a customer. With SS&C as Customer Zero, we optimized WorkHQ through real-time, observable, everyday use. What our enterprise clients get is a platform built for their world, proven in ours.”

 

 

WorkHQ offers:

 

 

• Centralized control: Unlike fragmented point tools or AI-only platforms, WorkHQ enables organizations to design, orchestrate, execute, and manageall types of automated work; AI agents, digital workers, and APIs together, with people in the loop where required.
• Governance by design: Security, auditability and compliance are embedded at the workflow level. Built‑in governance, human‑in‑the‑loop oversight and the SS&C AI Gateway AI governance layer ensure organisations can adopt AI faster while remaining compliant.
• Hybrid automation approach: WorkHQ complements existing RPA and BPM investments, enabling customers to introduce AI agents where they add value while retaining deterministic automation where control is essential.
• Builds on existing foundations: WorkHQ is designed to complement and connect with existing Blue Prism platforms, enabling innovation without disrupting the existing technology infrastructure.
• Reusability: Workflows and AI agents aredesigned to be modular, reusable and composable, cutting time to automation and increasing scale across enterprises.

 

 

“Organizations across the globe are forging ahead with the use of AI agents. According to IDC research, over the coming year, organizations expect to roughly double the number of types of AI agents they deploy into production,” said Neil Ward-Dutton, V.P. of Agentic Automation & AI Technology research at IDC. “To deliver measurable, lasting value from their AI investments at scale, organizations are focusing on unifying tools and practices relating to orchestration and governance. Platforms capable of enabling this will create huge value.”

 

WorkHQ provides a foundation for enterprises to move from isolated AI use cases to governed, enterprise-wide automation enabling organizations to scale from dozens to thousands of AI agents while maintaining control, transparency, and resilience. Learn more about WorkHQ here.

 

 

About SS&C Technologies

 

 

SS&C is a global provider of services and software for the financial services and healthcare industries. Founded in 1986, SS&C is headquartered in Windsor, Connecticut, and has offices around the world. More than 23,000 financial services and healthcare organizations, from the world’s largest companies to small and mid-market firms, rely on SS&C for expertise, scale and technology.

 

 

Additional information about SS&C (Nasdaq: SSNC) is available at www.ssctech.com.

 

 

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View source version on businesswire.com: https://www.businesswire.com/news/home/20260429512507/en/