• Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years
• If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer

TOKYO–(BUSINESS WIRE)– Enhertu^® (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the first-line treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer.

Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast09 phase 3 trial presented at the 2025 American Society of Clinical Oncology Annual Meeting and subsequently published in The New England Journal of Medicine. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU.

In DESTINY-Breast09, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab (THP) (hazard ratio: 0.56; 95% confidence interval [CI]: 0.44-0.71; p<0.00001) in patients (n=383) with HER2 positive metastatic breast cancer who had not received prior chemotherapy or HER2 targeted therapy or had received neoadjuvant or adjuvant HER2 targeted therapy more than six months before the diagnosis of advanced or metastatic disease. Median progression-free survival (PFS) was 40.7 months (95% CI: 36.5-not estimable [NE]) with Enhertu in combination with pertuzumab compared to 26.9 months (95% CI: 21.8-NE) with THP as assessed by blinded independent central review (BICR). The PFS benefit was consistent across subgroups, including the prespecified stratification factors of hormone receptor (HR) status, de novo or recurrent disease and PIK3CA mutation status.

Confirmed objective response rate (ORR) was 85.1% (95% CI: 81.2-88.5) for Enhertu in combination with pertuzumab compared to 78.6% (95% CI: 74.1-82.5) with THP. There were 58 (15.1%) complete responses (CR) and 268 (70.0%) partial responses (PR) with Enhertu plus pertuzumab compared to 33 (8.5%) CRs and 271 (70.0%) PRs with THP. Median duration of response (DOR) for Enhertu plus pertuzumab exceeded three years (39.2 months) versus 26.4 months for THP.

“Enhertu in combination with pertuzumab improved progression-free survival by more than one year compared with the current first-line standard of care, representing a meaningful advantage early in the treatment of patients with metastatic HER2 positive disease,” said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. “Today’s positive CHMP opinion brings us closer to making Enhertu available in the EU as a first-line treatment option for eligible patients with HER2 positive metastatic breast cancer, marking an important milestone in moving this medicine earlier in the treatment pathway.”

“HER2 positive metastatic breast cancer is an aggressive subtype, so starting patients on an effective HER2 targeted treatment early and continuing it for as long as they benefit can have a meaningful impact on long-term outcomes,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. “DESTINY-Breast09 sets a new benchmark with a median progression-free survival of more than three years, underscoring the potential of Enhertu plus pertuzumab to redefine first-line treatment for patients with HER2 positive metastatic breast cancer.”

The safety profile of Enhertu in combination with pertuzumab in DESTINY-Breast09 was consistent with the known profiles of each individual treatment with no new safety concerns identified. The most common grade 3 or higher treatment-related adverse events that occurred in patients treated with Enhertu in combination with pertuzumab (n=381) were neutropenia (23.9%), hypokalemia (10.2%), and anemia (8.4%). Interstitial lung disease (ILD) or pneumonitis occurred in 12.1% of patients treated with Enhertu in combination with pertuzumab as determined by an independent adjudication committee. The majority of ILD or pneumonitis events were low grade (grade 1 [n=17; 4.5% or grade 2 [n=27; 7.1%]). There were two grade 5 events (0.5%) of ILD or pneumonitis in the Enhertu plus pertuzumab arm.

Enhertu (5.4 mg/kg) in combination with pertuzumab is approved in India, Israel, Saudi Arabia, Singapore, South Korea, Switzerland, the United Arab Emirates and the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial.

Enhertu is also under review in the EU for patients with HER2 positive breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment based on data from the DESTINY-Breast05 trial.

About DESTINY-Breast09

DESTINY-Breast09 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP as first-line treatment in patients with HER2 positive metastatic breast cancer.

Patients were randomized 1:1:1 to receive either Enhertu monotherapy with a pertuzumab matching placebo; Enhertu in combination with pertuzumab; or THP. Randomization was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), HR status and PIK3CA mutation status.

The primary endpoint of DESTINY-Breast09 is PFS as assessed by BICR in both the Enhertu monotherapy and Enhertu combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, ORR, DOR, pharmacokinetics and safety. The investigational arm assessing Enhertu monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis.

DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Positive Metastatic Breast Cancer

Breast cancer is the most common cancer in women worldwide and the leading cause of cancer-related deaths among women.¹ Approximately 2.4 million breast cancer cases were diagnosed in 2024, with more than 690,000 deaths globally.¹ In Europe, approximately 540,000 cases of breast cancer are diagnosed annually, with more than 140,000 deaths.² While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or whose disease has progressed to metastatic disease are expected to live five years following diagnosis.³

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.⁴ HER2 protein overexpression may occur as a result of HER2 gene amplification.⁴ Approximately one in five cases of breast cancer is considered HER2 positive.⁵

HER2 positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.⁵ While HER2 targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.^6,7,8 Further, approximately one in three patients do not receive any treatment following first-line therapy due to disease progression or death.^9,10

About Enhertu

Enhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4 mg/kg) followed by THP is approved in China, Singapore and the U.S. as a neoadjuvant treatment for adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer based on the results from the DESTINY-Breast11 trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (5.4 mg/kg) is approved in the U.S. for the adjuvant treatment of adult patients with HER2 positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial.

Enhertu (5.4 mg/kg) in combination with pertuzumab is approved in India, Israel, Saudi Arabia, Singapore, South Korea, Switzerland, the United Arab Emirates and the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial.

Enhertu (5.4 mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4 mg/kg) is approved in more than 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

Enhertu (5.4 mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

Enhertu (5.4 mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Continued approval in the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the Enhertu Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of Enhertu as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize Enhertu in March 2019 and Datroway^® in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway.

About the ADC Portfolio of Daiichi Sankyo

The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo.

The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include Enhertu and Datroway, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo.

An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING.

Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo

Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit www.daiichisankyo.com.

REFERENCES:

¹ World Health Organization. Global Status Report On Cancer 2026: The Future We Choose Together. Accessed July 2026.

² World Health Organization. Breast Fact Sheet. Accessed July 2026.

³ National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer Subtypes. Accessed July 2026.

⁴ Cheng X. Genes (Basel). 2024;15(7):903.

⁵ Tarantino P, et al. Ann Oncol. 2023;34(8):645-659.

⁶ Swain SM, et al. Lancet Oncol. 2020;21(4):519-530.

⁷ Blumenthal G, et al. Clin Cancer Res. 2013;19(18):4911-4916.

⁸ Tripathy D, et al. Oncologist. 2020;25(2):e214-e222.

⁹ Hall PS, et al. Presented at SABCS Annual Meeting 2023.

¹⁰ Hartkopf AD, et al. Geburtshilfe Frauenheilkd. 2024;84(5):459-469.

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Contacts

MEDIA CONTACTS:
Global:
Jennifer Brennan

jennifer.brennan@daiichisankyo.com
+ 1 908 900 3183 (mobile)

EU:
Simone Jendsch-Dowé

simone.jendsch-dowe@daiichisankyo.com
+49 (89) 78080 (office)

Japan:
DS-PR_jp@daiichisankyo.com

INVESTOR RELATIONS CONTACT:
DaiichiSankyoIR_jp@daiichisankyo.com

• Samsung Bioepis reports revenue of 847.1 billion KRW and an operating profit of 230.6 billion KRW in the first half of 2026, recording 6% year-over-year growth
• Expanding direct commercialization in Europe to five products with the launch of OPUVIZ 40 mg/mL vial, a biosimilar to Eylea¹ (aflibercept)
• First to announce preliminary results from Phase 1, 3 clinical studies for SB27, a biosimilar candidate referencing Keytruda² (pembrolizumab)
• Samsung Epis Holdings continuing to secure next-generation growth engines through establishment of a global R&D hub in China

INCHEON, Korea–(BUSINESS WIRE)– Samsung Epis Holdings (KRX: 0126Z0), an investment company dedicated to innovations in biopharmaceuticals and biotechnology, today announced its financial results for the second quarter and first half of fiscal year 2026.

“We delivered solid first-half 2026 results, achieving 6% growth year-over-year. This performance demonstrates the resilience of our biosimilar portfolio in the global market,” said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We remain confident in our growth trajectory; increasing product demand in Europe and the US is expected to be reflected sequentially in the second-half results, which would result in steady business performance for the fiscal year.”

Second Quarter and First Half 2026 Results – Samsung Bioepis

Samsung Bioepis, a 100% owned subsidiary of Samsung Epis Holdings, recorded revenue of 847.1 billion KRW and an operating profit of 230.6 billion KRW in the first half of 2026. This represents an increase of 45.5 billion KRW (+6%) in revenue and 12.8 billion KRW (+6%) in operating profit compared to the same period last year.

For the second quarter, the company recorded revenue of 392.2 billion KRW and an operating profit of 86.6 billion KRW; revenue and operating profit decreased by 8.8 billion KRW (-2%) and by 3.2 billion KRW (-4%) respectively compared to the same period last year.

Business Updates

• Samsung Bioepis has expanded direct commercialization in Europe to five products with the launch of OPUVIZ (aflibercept) 40 mg/mL vial in May 2026. In the US, the company has expanded its market presence with the introduction of OSPOMYV^® (denosumab-dssb). Furthermore, the company is expanding its commercial footprint in international markets, including Japan where it launched its first biosimilar product in May 2026 through partnership with NIPRO Corporation. The company also announced the expansion of its global development and commercialization agreement with Organon to commercialize PYZCHIVA^® (ustekinumab), a biosimilar referencing Stelara³ (ustekinumab), in Canada.
• In June 2026, the company announced preliminary results from Phase 1 and Phase 3 clinical studies for SB27, a biosimilar candidate referencing Keytruda (pembrolizumab). Phase 1 study demonstrated pharmacokinetic (PK) equivalence between SB27 and Keytruda while Phase 3 study demonstrated equivalent objective response rate (ORR) at Week 24. Both studies are expected to be completed within 2026.
• SBE303, the company’s first novel antibody-drug conjugate (ADC) candidate, entered the global Phase 1 clinical study in March. SBE303 is engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer. Nonclinical characterization of SBE303 was presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting in April, highlighting its anti-tumor efficacy, safety, tolerability profile and a promising ability to work in combination with existing immuno-oncology therapies.

Second Quarter and First Half 2026 Results – Samsung Epis Holdings

• Samsung Epis Holdings recorded consolidated revenue of 845.8 billion KRW and an operating profit of 149.3 billion KRW in the first half of 2026, reflecting non-cash accounting adjustments. For the second quarter, the company achieved revenue of 391.9 billion KRW and an operating profit of 58.8 billion KRW. Samsung Epis Holdings is stabilizing its business under the holding company structure based on the solid performance of its core subsidiary, Samsung Bioepis, and established its first overseas R&D base in China to strengthen its novel therapeutic development capabilities.

Disclaimer

This document contains ‘forward-looking statements’ regarding future expectations, projections, plans, and anticipation. ‘Forward-looking statements’ are matters that pertain to the Company’s future business and financial performance, and are subject to uncertainties such as trends in domestic and international financial markets, including but not limited to fluctuations in exchange rates and/or interest rates.

‘Forward-looking statements,’ by their nature, addresses matters that may be uncertain; actual results may be materially different from those expressed in this document.

About Samsung Epis Holdings Co., Ltd.

As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: www.samsungepisholdings.com.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

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Contacts

Media Contact
Anna Nayun Kim, nayun86.kim@samsung.com
Yoon Kim, yoon1.kim@samsung.com

Wereldleider in het ontdekken van geneesmiddelen werkt met Navan samen om operationele uitmuntendheid te bevorderen en komaf te maken met handmatige rappertering van uitgaven

PALO ALTO, Calif.–(BUSINESS WIRE)– Navan (NASDAQ: NAVN), het wereldwijde platform voor bedrijfsreizen en -uitgaven aangestuurd door AI, maakte vandaag bekend dat Evotec (NASDAQ: EVO; Frankfurt Prime Standard: EVT), het internationale bedrijf gespecialiseerd in het ontdekken en ontwikkelen van geneesmiddelen, Navan heeft geselecteerd om zijn volledige bedrijfs-T&E (Travel & Expense) programma in de belangrijkste wereldwijde markten te beheren.

Dit persbericht bevat multimedia. Bekijk hier het volledige persbericht: https://www.businesswire.com/news/home/20260722139118/nl/

Global drug discovery leader partners with Navan to drive operational excellence and eliminate manual expense reporting

Evotec is een bedrijf actief in biowetenschappen dat pionierswerk verricht voor de toekomst van het ontdekken en ontwikkelen van geneesmiddelen. Sinds jaar en dag had het bedrijf T&E onafhankelijk in verschillende landen beheerd, wat betekent dat werknemers met een patchwork van verschillende tools en manuele offline processen moest omgaan.

Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, die als enige rechtsgeldig is.

Bekijk het oorspronkelijke bericht op businesswire.com: https://www.businesswire.com/news/home/20260722139118/nl/

Contacts

Media: press@navan.com

Enterprise Clinical Decision Support solution available to 30,000 clinicians in more than 50 Norwegian hospitals

WALTHAM, Mass.–(BUSINESS WIRE)– Wolters Kluwer Health announced that Norway’s health system has renewed its adoption of UpToDate Enterprise Edition, a market-leading Clinical Decision Support (CDS) solution, for its nationwide health system which includes over 50 public hospitals and 11,000 beds in over 20 trusts. This extends a 15 year partnership with Helsebiblioteket, now part of the Norwegian Institute of Public Health (NIPH).

Helping clinicians on a national scale

Kjell Tjensvoll, Team Leader for Helsebiblioteket said, ‘‘Providing frontline teams with easy access to the latest medical knowledge is vital in reducing unwarranted variation and improving patient care on a national scale. UpToDate Enterprise Edition enables this, and we are delighted to strengthen our relationship with Wolters Kluwer and provide continued support for clinicians across the country.’’

UpToDate Enterprise Edition was selected by Helsebiblioteket, the Norwegian Electronic Health Library. The selection followed a competitive process by the Norwegian regional health trusts and the National Institute for Public Health. Among candidates, UpToDate achieved the highest scores across all quality criteria.

Faster decisions and AI-powered answers

With UpToDate Enterprise Edition, doctors, nurses, pharmacists, students, and allied health professionals all have access to trusted, evidence‑based guidance, supporting faster, more confident decisions at the point of care.

In addition to providing continued access to UpToDate, clinicians in Norway will have access to new enterprise features for patient treatment including support for mental health medication transitions, renal dosing and Clinical Pathways which are interactive guides to help make appropriate decisions related to specific clinical questions with algorithms and calculators.

Clinicians in Norway will soon also be piloting UpToDate Expert AI to provide feedback to support UpToDate’s continued development and improvement of UpToDate Expert AI. During this pilot stage, UpToDate Expert AI will be used for general information and education purposes, rather than in the context of patient care.

“As care grows more complex, healthcare teams need more than point solutions. They need integrated clinical intelligence across workflows, team interactions, and patient care,” said Christian Cella, Vice President and General Manager, International segment, Wolters Kluwer Health. “We are pleased to continue our relationship to help Norway in delivering healthcare across the country.”

More than 100 independent studies have linked the use of UpToDate with improvements in hospital performance metrics, including reduced length of stay, fewer medical errors, and decreased unnecessary diagnostic testing.

Learn more about UpToDate Enterprise Edition.

###

About Wolters Kluwer

Wolters Kluwer (EURONEXT: WKL) is a global leader in information solutions, software and services for professionals in healthcare; tax and accounting; financial and corporate compliance; legal and regulatory; corporate performance and ESG. We help our customers make critical decisions every day by providing expert solutions that combine deep domain knowledge with technology and services.

Wolters Kluwer reported 2025 annual revenues of €6.1 billion. The group serves customers in over 180 countries, maintains operations in over 40 countries, and employs approximately 21,100 people worldwide. The company is headquartered in Alphen aan den Rijn, the Netherlands.

Wolters Kluwer shares are listed on Euronext Amsterdam (WKL) and are included in the AEX, Euro Stoxx 50, and Euronext 100 indices. Wolters Kluwer has a sponsored Level 1 American Depositary Receipt (ADR) program. The ADRs are traded on the over-the-counter market in the U.S. (WTKWY).

For more information, visit www.wolterskluwer.com, follow us on LinkedIn, Facebook, YouTube and Instagram.

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Contacts

Media Contact
Suzanne Moran

Associate Director, External Communications

Wolters Kluwer Health

+1 781-255-5843

suzanne.moran@wolterskluwer.com

• NAVIGATE comprises two pivotal Phase 3 studies investigating nizubaglustat
• Recruitment completed in Phase 3 registrational study in patients with late-infantile and juvenile GM1/GM2 gangliosidoses
• Enrollment in Niemann-Pick type C disease (NPC) Phase 3 study is ongoing
• Topline data from GM1/GM2 gangliosidoses Phase 3 study is anticipated in early 2028

LEIDEN, Netherlands–(BUSINESS WIRE)– Azafaros, a private company building a portfolio of disease-modifying therapeutics to become a leader in lysosomal storage disorders (LSDs) focused on addressing neurological symptoms, today announced the completion of patient recruitment in its Phase 3 study evaluating nizubaglustat for the treatment of GM1/GM2 gangliosidoses.

“Completing enrollment in our Phase 3 GM1/GM2 study is a significant step toward potentially bringing nizubaglustat to patients and families living with these devastating neurodegenerative diseases,” said Stefano Portolano, Chief Executive Officer at Azafaros. “We are deeply grateful to the patients, caregivers, investigators and advocacy groups who have made this milestone possible. As we advance the GM1/GM2 study toward data readout and regulatory submission, we continue to enroll in our Phase 3 NPC study and remain focused on our goal of addressing the significant unmet medical needs faced by these rare disease communities.”

Professor Roberto Giugliani, Principal Investigator, said: “With enrollment now complete, we look forward to generating the clinical evidence needed to evaluate the potential of nizubaglustat for patients living with GM1/GM2 gangliosidoses. These are devastating neurodegenerative disorders with no treatments approved for use in these patients today. Robust Phase 3 data from a long-term randomized study are essential to advancing potential the first treatment option for patients and their families, and we hope that the data from this study are supportive of approval.”

Azafaros’ NAVIGATE program consists of two global Phase 3 multi-center, randomized, placebo-controlled studies designed to evaluate the potential of oral nizubaglustat to alter disease progression and improve functional outcomes in patients with late-infantile and juvenile-onset forms of NPC or GM1/GM2 gangliosidoses. The Phase 3 GM1/GM2 study enrolled a minimum of 75 patients across 25 clinical sites in 13 countries. The study is evaluating oral administration of nizubaglustat compared to treatment with placebo over an 18-month treatment period, with efficacy assessments focused on neurological manifestations and disease progression. All patients treated in the study are eligible to continue nizubaglustat following the 18-month treatment period in an open label extension study. Enrollment in the NAVIGATE Phase 3 study in patients with NPC, recruiting 72 patients, is ongoing.

About Nizubaglustat

Nizubaglustat is a small molecule, orally available and brain penetrant azasugar with a unique dual mode of action, developed as a potential treatment for rare lysosomal storage disorders with neurological involvement, including GM1 and GM2 gangliosidoses and Niemann-Pick type C disease (NPC).

Nizubaglustat has received Rare Pediatric Disease Designations (RPDD) for the treatment of GM1 and GM2 gangliosidoses and NPC, Orphan Drug Designations (ODD) for GM1 and GM2 gangliosidosis (Sandhoff and Tay-Sachs Diseases) and NPC, as well as Fast Track Designation and IND clearance for GM1/GM2 gangliosidoses and NPC from the US Food and Drug Administration (FDA). Additionally, nizubaglustat has been awarded Orphan Medicinal Product Designation (OMPD) for the treatment of GM1 and GM2 gangliosidoses by the European Medicines Agency (EMA) and Innovation Passport for the treatment of GM1 and GM2 gangliosidoses from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).

About GM1 and GM2 gangliosidoses

GM1 gangliosidosis and GM2 gangliosidosis (Tay-Sachs and Sandhoff diseases) are lysosomal storage disorders caused by the accumulation of GM1 or GM2 gangliosides respectively, in the central nervous system (CNS). This results in progressive and severe neurological impairment and premature death. These diseases mostly affect infants and children, and no disease-modifying treatments are currently available.

About Niemann-Pick type C disease (NPC)

Niemann-Pick type C disease is a progressive, life-limiting, neurological, lysosomal storage disorder, caused by mutations in the NPC1 or NPC2 gene and aberrant endosomal-lysosomal trafficking, leading to the accumulation of various lipids, including gangliosides in the CNS. The onset of the disease can happen throughout the lifespan of an affected individual, from prenatal life through adulthood.

About Nizubaglustat NAVIGATE Phase 3 Program

The Azafaros NAVIGATE Phase 3 program comprises two global studies evaluating oral nizubaglustat in patients with late-infantile and juvenile-onset forms of NPC or GM1/GM2 gangliosidoses. Both studies are randomized, double-blind, placebo-controlled, multicenter trials designed to assess the efficacy, safety and tolerability of nizubaglustat over an 18-month treatment period. The studies are being conducted across major regions including North America, Europe, Latin America, India, Pakistan and other selected countries.

About Azafaros

Azafaros is a clinical-stage company founded in 2018 with a deep understanding of rare genetic disease mechanisms using compound discoveries made by scientists at Leiden University and Amsterdam UMC and is led by a team of highly experienced industry experts. Azafaros aims to build a pipeline of disease-modifying therapeutics to offer new treatment options to patients and their families. By applying its knowledge, network and courage, the Azafaros team challenges traditional development pathways to rapidly bring new drugs to the rare disease patients who need them. Azafaros is supported by leading healthcare investors including Forbion, Jeito Capital, Seroba, Pictet Group, BioGeneration Ventures (BGV), BioMedPartners, Asahi Kasei Pharma Ventures, and Schroders Capital.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260723820422/en/

Contacts

For further information:
Azafaros B.V.

Email: info@azafaros.com
www.azafaros.com

Ad hoc announcement pursuant to Art. 53 LR

ZUG, Switzerland–(BUSINESS WIRE)– Galderma Group AG (SIX: GALD), the pure-play dermatology category leader, today announced its financial results for the first half of 2026.

• Net sales reached 3.134 billion USD, surpassing 3 billion USD for the first time in the first six months of the year and representing net sales growth of 24.6% at constant currency¹.
• Broad-based, double-digit growth in both International markets and the U.S. as well as in all product categories, primarily driven by volume and complemented by favorable mix.
• Outperforming the market in each product category, with net sales growth year-on-year at constant currency of 12.1% in Injectable Aesthetics, 16.4% in Dermatological Skincare, and 67.9% in Therapeutic Dermatology.
• Demonstrating leadership in dermatology through ongoing geographic expansion and differentiated innovation, including Nemluvio^® (nemolizumab), which generated 433 million USD in net sales, Relfydess (RelabotulinumtoxinA), which continues to ramp-up with approvals in 33 International markets, alongside continued investment in science-based innovation and medical education.
• Core EBITDA² margin expansion of 328 basis points at constant currency, ahead of initial expectations for the first half, with Core EBITDA reaching 802 million USD, up 42.8% year-on-year at constant currency, and a Core EBITDA margin of 25.6%.
• Core EPS³ grew to 2.34 USD, up 68.5% year-on-year, driven by strong Core EBITDA and reduced financing costs.
• Raising 2026 full-year net sales guidance to 19-21% growth at constant currency (previously 17-20%) based on a strong trajectory, and confirming Core EBITDA margin of approximately 26% at constant currency.

Commercial performance

Galderma is on a strong trajectory in 2026 to deliver on another year of opportunities, as it continues to execute on its proven, growth-driven integrated dermatology strategy. Growth for the year is expected to be broad-based across its portfolio, complemented by new launches and geographic expansion.

For the first half of 2026, Galderma achieved net sales of 3,134 million USD, surpassing 3 billion USD for the first time in the first six months of a year. Year-on-year net sales growth was 24.6% at constant currency, predominantly driven by volume and complemented by favorable mix. Excluding the anticipated effects of Nemluvio’s gross-to-net pricing evolution, price contributed positively to growth. Growth remained strong in the second quarter of the year, with net sales up 23.8% year-on-year at constant currency.

Net sales growth remained broad-based, with double-digit growth in most of Galderma’s top 10 markets and across all product categories. Galderma continued to outperform the market in each of its product categories.

Injectable Aesthetics

Injectable Aesthetics net sales for the first six months were 1,437 million USD, with year-on-year growth of 12.1% at constant currency. U.S. phasing effects, favorable in the first quarter, unwound in the second quarter.

Neuromodulators delivered net sales of 826 million USD, up 13.4% year-on-year at constant currency. Executing on its Neuromodulator portfolio strategy, Galderma continued to gain market share in both the U.S. and International markets. Dysport^® continued to grow in all top markets, with particularly strong performance across Asia and Latin America as well as continued double-digit growth in Europe where Relfydess has been launched. Relfydess built further momentum in existing markets, supported by positive feedback from healthcare professionals and patients, and was launched in three additional markets, including its first Asian market, Hong Kong. Galderma also continued to advance Relfydess regulatory reviews, with the product now approved in 33 markets and regulatory filings ongoing in additional territories.

As announced on July 1, Galderma received a recent Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) addressing remaining observations on the manufacturing site and analytical method optimization. Galderma is fully committed to resolving these topics promptly and to continue working constructively with the FDA; advancing RelabotulinumtoxinA in the U.S. remains a top priority. In light of strong Neuromodulators momentum in both International markets and the U.S., Galderma does not expect the U.S. CRL to impact its ability to deliver on its 2023-2027 mid-term guidance, as updated in March 2026.

Fillers & Biostimulators achieved net sales of 611 million USD, up 10.5% year-on-year at constant currency, despite continued softness in the Fillers market. Galderma gained share in both the U.S. and International markets in Fillers & Biostimulators, with continued double-digit growth for Sculptra^® in both geographies. Galderma also advanced its portfolio and geographic expansion, including ongoing scaling of Sculptra in China and new Restylane^® indications in the U.S. In Fillers, Galderma rolled out the Restylane SkinBoosters SmartClick syringe in China and received its third approval for Restylane SHAYPE, now approved in Thailand for chin augmentation. In Biostimulators, Sculptra was launched in Indonesia and approved in India, as well as in Australia for body indications, enabling training for use in the gluteal area, posterior thighs, décolletage, and upper arms.

Dermatological Skincare

Dermatological Skincare net sales for the first six months were 848 million USD, with year-on-year growth of 16.4% at constant currency.

Galderma maintained strong growth momentum across its Dermatological Skincare flagship brands, Cetaphil^® and Alastin^®. As anticipated, growth was strong benefitting from a lower comparable base in the period. Growth was positive in both the U.S. and International markets, with double-digit growth for Cetaphil in fast-growing International markets and for Alastin in both geographies.

Market outperformance continues to be driven by focused execution, innovation and portfolio synergies, with e-commerce remaining the fastest-growing channel. Cetaphil performance remains outstanding in China, while markets globally are benefitting from scaling existing innovation, including Cetaphil Skin Activator in the U.S., Cetaphil Baby in India, and Cetaphil Purifying Acne serum in China. Alastin continues to outperform the physician-dispensed market in the U.S. while Galderma continues to invest in its expansion in International markets, with recent launches in China, Australia and now Japan and Taiwan.

Therapeutic Dermatology

Therapeutic Dermatology net sales for the first six months were 848 million USD, up 67.9% year-on-year at constant currency.

Growth remained very strong, driven by the ramp-up of Nemluvio, complemented by higher-than-expected growth from the mature Therapeutic Dermatology portfolio during the period against a low comparative base and benefitting from delayed generic entries.

Nemluvio continues on a strong launch trajectory globally, with net sales for the first half of the year of 433 million USD. The U.S. continues to represent the vast majority of sales, with a greater contribution from atopic dermatitis than prurigo nodularis. Nemluvio also contributed more than half of Therapeutic Dermatology net sales overall for the first time.

In the U.S., Nemluvio paid new patient starts (NBRx) from mid-June to early July 2026 trended at approximately 42% market share in prurigo nodularis and 9% in atopic dermatitis. Underlying demand remains strong, as the majority of patients starting treatment continue to be new to biologics.

In International markets, which represent only a small portion of total Nemluvio sales, the launch trajectory continues to be even stronger. In addition, regulatory reviews and approvals for Nemluvio continue to progress, including the recent approval in Brazil for both prurigo nodularis and atopic dermatitis, alongside additional reimbursement wins in key International markets that support broader patient access.

Galderma is committed to its mature Therapeutic Dermatology portfolio globally, continuing to expand through new geographic launches and lifecycle management of its molecules, even in the face of strong generic pressures. This includes the recent U.S. FDA approval of Differin^® Epiduo^® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) use in ages 12 years and older, marking an important Prescription-to-OTC transition in acne care.

Science-led innovation and medical education

Galderma continues to reinforce its science-led innovation and medical education in dermatology. This includes advancing its R&D pipeline across product categories, while exploring external opportunities. It also includes generating new scientific data and insights to be presented at global congresses and company-led medical education events.

In terms of its innovative R&D pipeline, Galderma progressed two clinical-stage Biostimulator assets in Injectable Aesthetics, multiple development programs with differentiated innovation in Dermatological Skincare, and potential new indications for nemolizumab in Therapeutic Dermatology.

For nemolizumab specifically, this includes the completion of enrollment in the Phase II Chronic Pruritus of Unknown Origin (CPUO) trial and ongoing enrollment in the Phase II Systemic Sclerosis (SSc) trial, with a new SSc publication in the Journal of Scleroderma and Related Disorders. It also includes the ongoing submission preparation of nemolizumab in children aged 2 to 11 with moderate-to-severe atopic dermatitis in the U.S., following clinically meaningful late-breaking data presented in the first quarter.

Galderma leveraged its leading presence at global congresses and company-led platforms to present new clinical data and real-world insights. At the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2026, Galderma presented late-breaking Nemluvio data including insights on fast onset of action in adolescents with moderate-to-severe atopic dermatitis. Additionally, Galderma shared insights from two large-scale global surveys underscoring the patient needs addressed by its Injectable Aesthetics portfolio, including the world’s most extensive skin quality profiling survey and a survey on patient and healthcare professional expectations with anti-wrinkle treatments.

Financial scorecard

For the first half of 2026, Galderma delivered 802 million USD in Core EBITDA, growing 42.8% year-on-year at constant currency. Core EBITDA margin expanded to 25.6%, representing a significant 328 basis point improvement at constant currency compared to the first half of 2025. Core EBITDA growth outpaced net sales growth, ahead of expectations for the period reflecting strong net sales growth, phasing of operating expenses, and a one-time tariff refund. Improvements in operating expenses more than offset the gross margin impact of product mix and the anticipated gross-to-net evolution and higher royalty rates on Nemluvio as it continues its strong ramp-up.

Growth was even greater in Core net income⁴ and Core EPS, driven by strong Core EBITDA and lower financing costs, benefitting from the successful refinancing in March of the Term Loan via a Eurobond issuance. Core net income for the first half was 547 million USD, up 66.3%, and Core EPS was 2.34 USD, up 68.5%.

In addition to the dividend payment of 104 million USD, Galderma continued to support shareholder returns with share repurchases of 302 million USD, held in treasury, executed in March during the final accelerated bookbuild offering of Galderma shares by the EQT-led consortium of investors.

Strong cash generation combined with the strong EBITDA growth allowed Galderma to further enhance its financial profile, with net leverage⁵ reduced to 1.2x at the end of June 2026.

Outlook

2026 remains a key year to capitalize on opportunities and drive net sales growth. The five key opportunity areas for the year include 1) significant launches, including the strong uptake of Nemluvio and Relfydess, the geographic expansion of Restylane and Sculptra, and ongoing innovation in Dermatological Skincare, 2) further market share gains, 3) a strengthened financial profile, 4) a shift to long-term growth with increasing strategic optionality, and 5) dynamic commercial investments to continue to drive growth.

Based on a stronger-than-anticipated trajectory in the first half of the year, especially in Dermatological Skincare, Therapeutic Dermatology and Neuromodulators, Galderma is raising its net sales guidance for the full year. Net sales growth is now expected in the range of 19-21% at constant currency, up from previously 17-20%. Galderma is confirming its margin expansion expectation for the year, with a Core EBITDA margin of approximately 26% at constant currency, with the intent to continue investing behind growth opportunities in the second half.

The 2026 full-year guidance factors in Galderma’s manageable exposure to announced U.S. tariffs and expected effects from recent related proclamations, along with the ability to absorb potential consumer demand deterioration in the second half of 2026 given the volatile political and macroeconomic environment.

While guidance is at constant currency, based on spot rates at the end of June 2026, foreign exchange is expected to have a positive impact on net sales and Core EBITDA absolutes, but a negative impact on reported Core EBITDA margin. The evolution of Galderma’s exposure to key foreign exchange currency pairs is available in the Appendix.

Galderma now plans to provide mid-term guidance beyond 2027 in the first quarter of 2027, following discussions expected later this year with the U.S. FDA on the BLA resubmission of RelabotulinumtoxinA.

Webcast details

Galderma will host a financial results call today at 13:00 CEST to discuss its first half 2026 results and respond to questions from financial analysts. Investors and the public may access the webcast by registering on the Galderma Investor Relations website at https://investors.galderma.com/events-presentations, a recording will also be made available after the event.

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

Appendices

Appendix 1: H1 2026 net sales by product category and geography

Appendix 2: Q2 2026 net sales by product category and geography

Appendix 3: Reconciliation of H1 2026 P&L from IFRS to Core reporting

Appendix 4: Reconciliation of H1 2026 of Core EBITDA to IFRS Net Income

Appendix 5: Reconciliation of H1 2026 from IFRS Net Income to Core Net Income

Appendix 6: H1 2026 Total Net Indebtedness⁷

Appendix 7: Additional modelling metrics

Appendix 8: Overview of foreign exchange rate exposure

Exchange rates for top FX impacts, compared to the USD

Notes and references

Note: Due to rounding numbers presented may not add up precisely to the totals provided and percentages may not precisely reflect the absolute figures. All ratios, subtotals and variances are calculated using the underlying amount rather than the presented rounded amount.

1. Constant currency year-on-year growth is defined as the annual growth rate of net sales excluding the impact of exchange rates movements. The impact of changes in foreign exchange rates are excluded by translating all reported revenues during the two periods at average exchange rates in effect during the previous year.
2. Core EBITDA is defined as EBITDA excluding the following items that are deemed non-core: acquisition and disposal; integration and carve-out related income and expenses; onerous contracts; business disposal gains and losses; litigation related items as well as impairment of PPE and intangible assets. In addition, non-Core items include other income and expense items that management considers non-Core, as well as restructuring and reorganization items expected to accumulate within approximately a year to be over a 2 M USD threshold. Items that management considers non-Core may include, but are not limited to carve-out and build-up-related project costs as well as post-acquisition-related accounting impacts
3. Core EPS is calculated as Core net income divided by the weighted average number of outstanding shares during the period.
4. Core Net Income is defined as net income adjusted for the same items that are treated as exceptional for purposes of defining Core EBITDA, as well as amortization of intangible assets and foreign exchange gains and losses on financing activities. Taxes on the adjustments between IFRS net income and Core Net Income take into account, for each individual item included in the adjustment, the tax rate that will finally be applicable to the item based on the jurisdiction where the adjustment will finally have a tax impact.
5. Leverage is defined as Total Net Indebtedness divided by Core EBITDA on a twelve-months rolling basis.
6. H1 2025 adjustments include 4 M USD litigation, 6 M USD onerous items, 2 M USD M&A, 9 M USD impairments, 4 M USD restructuring, 13 M USD for operating FX losses. H1 2026 adjustments include 11 M USD litigation, 5 M USD restructuring, 2 M USD other items; offset by 9 M USD for operating FX gains.
7. Indebtedness includes financial debt and lease liabilities.
8. Includes assumptions for other income and expenses related to tangible asset impairments, ongoing litigation and onerous items, restructuring charges and others, excluding M&A fees and the impact from Operating Fx.
9. On reported profit before tax.
10. Includes a one-time, non-cash benefit from recognizing deferred tax assets on past tax losses
11. Includes interest income and interest expense, excluding Fx impact.
12. Factors in the simulation of all foreign exchange rate exposures, including for currencies not listed in the table of exchange rates for top FX impact.

Forward-looking statements

Certain statements in this announcement are forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “plans”, “targets”, “aims”, ” believes”, “expects”, “anticipates”, “intends”, “estimates”, “will”, “may”, “continues”, “should” and similar expressions. These forward-looking statements reflect, at the time, Galderma’s beliefs, intentions and current targets/ aims concerning, among other things, Galderma’s results of operations, financial condition, industry, liquidity, prospects, growth and strategies and are subject to change. The estimated financial information is based on management’s current expectations and is subject to change. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions, intense competition in the markets in which Galderma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Galderma’s markets, and other factors beyond the control of Galderma). Galderma and its shareholders (as applicable), directors, officers, employees, advisors and representatives assume no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. You should not place undue reliance on forward-looking statements, which speak of the date of this announcement. Statements contained in this announcement regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. Some of the information presented herein is based on statements by third parties, and no representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, reasonableness, accuracy, completeness or correctness of this information or any other information or opinions contained herein, for any purpose whatsoever. Except as required by applicable law, Galderma has no intention or obligation to update, keep updated or revise this announcement or any parts thereof.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260722555754/en/

Contacts

For further information:

Media

Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com
+41 76 315 26 50

Richard Harbinson

Corporate Communications Director

richard.harbinson@galderma.com
+41 76 210 60 62

Investors

Emil Ivanov

Head of Strategy, Investor Relations and ESG

emil.ivanov@galderma.com
+41 21 642 78 12

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com
+41 21 642 76 43

PARIJS–(BUSINESS WIRE)– Met nog maar enkele maanden te gaan tot SIAL Paris 2026 (17–21 oktober, Paris Nord Villepinte) heeft de beurs de resultaten gepresenteerd van het nieuwe SIAL Insights 2026-rapport. Dit is een internationale analyse die tien belangrijke trends in kaart brengt die blijvende veranderingen teweeg zullen brengen in de voedselmarkten en het consumentengedrag.

Het rapport, dat tot stand is gekomen op basis van exclusieve gegevens van Kantar Food 360, Circana en ProtéinesXTC, belicht een meer gepersonaliseerde, functionele en op beleving gerichte benadering van voeding. Daarnaast brengt het de nieuwe afwegingen in kaart die consumenten maken in het licht van economische, gezondheids- en milieu-uitdagingen.

Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, die als enige rechtsgeldig is.

Bekijk het oorspronkelijke bericht op businesswire.com: https://www.businesswire.com/news/home/20260721638814/nl/

Contacts

Pers
Hoofd International Communications

Juliette.marzynski@comexposium.com

• Met deze goedkeuring wordt de goedgekeurde indicatie voor Crysvita uitgebreid naar zuigelingen van 1 maand tot 1 jaar oud, waardoor een vroegere behandeling mogelijk wordt bij een zeldzame, progressieve aandoening die de ontwikkeling van het skelet al vanaf de zuigelingentijd kan beïnvloeden.
• De goedkeuring geldt voor de hele Europese Unie en de Europese Economische Ruimte, waardoor de jongste patiënten met XLH toegang tot de behandeling hebben.

GALASHIELS, Schotland & MARLOW, Engeland–(BUSINESS WIRE)– Kyowa Kirin EMEA, een volledige dochteronderneming van Kyowa Kirin Co., Ltd. (TSE:4151), heeft vandaag bekendgemaakt dat de Europese Commissie (EC) een uitbreiding van de indicatie voor Crysvita^® (burosumab) voor de behandeling van X-gebonden hypofosfatemie (XLH) heeft goedgekeurd. Zuigelingen van 1 maand tot 1 jaar in de hele Europese Unie en de Europese Economische Ruimte kunnen deze behandeling nu ook krijgen.

Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, die als enige rechtsgeldig is.

Bekijk het oorspronkelijke bericht op businesswire.com: https://www.businesswire.com/news/home/20260721180215/nl/

Contacts

James Read

Mobiel: +44 (0) 7917922566

james.read@kyowakirin.com

LYON, Frankrijk–(BUSINESS WIRE)– Brenus Pharma heeft vandaag een uitbreiding van zijn Serie A-financieringsronde met € 11 miljoen ($ 12,6 miljoen) aangekondigd, waarmee het totale opgehaalde kapitaal sinds de oprichting op € 38 miljoen ($ 43,5 miljoen) komt. Deze financiering weerspiegelt de succesvolle realisatie van mijlpalen op het gebied van klinische ontwikkeling, regelgeving en bedrijfsontwikkeling. Hiermee wordt het risicoprofiel van STC-1010 (NCT06934538): de belangrijkste in-vivo-immunotherapie van het bedrijf in de klinische fase voor MSS mCRC – verlaagd, terwijl tegelijkertijd het eigen platform van het bedrijf in positie wordt gebracht voor uitbreiding met meerdere productkandidaten.

De financieringsronde werd ondersteund door aanzienlijke vervolginvesteringen van bestaande investeerders, waaronder Angelor, UI Investissement (beheerder van FRAI), Crédit Agricole (CACE Création, CACF Capital Innovation), Noshaq, Orsa (voorheen Investsud), BIO JAG en Bpifrance (via niet-verwaterende financiering).

Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, die als enige rechtsgeldig is.

Bekijk het oorspronkelijke bericht op businesswire.com: https://www.businesswire.com/news/home/20260720694082/nl/

Contacts

contact@brenus-pharma.com

MINNEAPOLIS–(BUSINESS WIRE)– HistoSonics heeft vandaag de opening aangekondigd van zijn uitgebreide trainingscentrum voor histotripsie in Hongkong. Hiermee wordt de positie van de stad als toonaangevend knooppunt voor artsenopleidingen, klinische samenwerking en innovatie in Azië versterkt.

Dit persbericht bevat multimedia. Bekijk hier het volledige persbericht: https://www.businesswire.com/news/home/20260720900103/nl/

Pictured at the expanded Histotripsy Training Center in Hong Kong. Front row (left to right): Dr. Angus Yuen, Chief Medical Officer, Gleneagles Hospital Hong Kong; Prof. Albert Chan, Director of Liver Cancer Surgery Centre, Gleneagles Hospital Hong Kong; Dr. Kenneth Tsang, Regional Chief Executive Officer, IHH Healthcare North Asia, and Chief Executive Officer, Gleneagles Hospital Hong Kong; Dr. Vince Lau, Director of Interventional Radiology Centre, Gleneagles Hospital Hong Kong; Dr. Joe Herman, Vice President, Medical Affairs, HistoSonics.
Back row (left to right): Jay Lee, APAC Regional Manager, HistoSonics; Eric Kwong, Hong Kong Sales Manager, Transmedic; Matt Brown, Director of OUS Professional Education, HistoSonics.

Het centrum, dat oorspronkelijk in mei 2025 in het Gleneagles Hospital Hong Kong werd geopend, was de eerste trainingsfaciliteit voor histotripsie in Azië. Sinds de opening heeft het centrum artsen uit de hele regio ontvangen voor praktijktrainingen en klinische observatie, wat heeft bijgedragen aan de versnelde invoering van histotripsie in Azië.

De uitgebreide faciliteit zal voorzien in de groeiende vraag naar opleidingen voor artsen, dankzij een grotere capaciteit voor praktijktrainingen, klinische observatie en multidisciplinaire onderwijsprogramma’s.

Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, die als enige rechtsgeldig is.

Bekijk het oorspronkelijke bericht op businesswire.com: https://www.businesswire.com/news/home/20260720900103/nl/

Contacts

Contactpersonen voor de media
Rebecca Koupal

Sr. Director Marketing

612-483-6378

Rebecca.Koupal@HistoSonics.com

Kimberly Ha

KKH Advisors

917-291-5744

kimberly.ha@kkhadvisors.com