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NRG Therapeutics Announces Senior Appointments as it Advances NRG5051 Towards First-in-Human Clinical Studies

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NRG Therapeutics Announces Senior Appointments as it Advances NRG5051 Towards First-in-Human Clinical Studies




NRG Therapeutics Announces Senior Appointments as it Advances NRG5051 Towards First-in-Human Clinical Studies

STEVENAGE, United Kingdom, Oct. 23, 2025 (GLOBE NEWSWIRE) — NRG Therapeutics Ltd. (“NRG”), an innovative neuroscience company targeting a novel mechanism to address mitochondrial dysfunction, is pleased to announce expansion of its team with the addition of three senior appointments in newly created roles: Sarah Almond as VP of Translational Biology; David Brocklebank as Director of Clinical Operations; and Kathryn Oliver as Director of Project Management.

NRG has identified a novel regulator of the mitochondrial permeability transition pore (mPTP) which is essential for pore opening and amenable to small molecule inhibition. This breakthrough has enabled the company to develop a new class of small molecule mPTP inhibitors which are designed to penetrate the brain effectively when taken orally. First-in-human studies of its lead development candidate NRG5051 are on track to commence in early 2026.

At NRG, Sarah Almond will be responsible for preclinical translational biology and will support the clinical biomarker strategy; David Brocklebank will be responsible for clinical operations and will support delivery of the phase 1 and 2 clinical trials; and Kathryn Oliver will provide project management support for NRG’s clinical asset NRG5051 and preclinical pipeline.

The team expansion follows NRG’s recent £50m series B financing led by SV Health Investors’ Dementia Discovery Fund (DDF) in a syndicate of leading international life science venture investors that also included British Business Bank, M Ventures, Novartis Venture Fund and Criteria Bio Ventures alongside existing investors Omega Funds and Brandon Capital. The new funds provide runway for completion of a Phase 2 clinical proof of concept study of NRG5051 in amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND), while also generating meaningful clinical data in Parkinson’s patients through a Phase 1b study.

NRG Therapeutics’ co-founder and CEO Neil Miller said,
“I am delighted to welcome Sarah, David and Kathryn to the team. Their combined skills and expertise will enable us to efficiently progress #NRG5051 through first-in-human clinical trials and into a PoC in #ALS/#MND, and to lay the ground for development in other indications including #Parkinson’s. They join us at a pivotal time as we seek to demonstrate the therapeutic potential of NRG’s first-in-class #mPTP inhibitors as disease modifying medicines for neurodegenerative diseases.”

NRG operates a semi-virtual business model, with an in-house R&D leadership and operations team in Stevenage, UK complemented by the expertise of experienced drug-discovery outsourcing partners. These new appointments grow the team to 11 including the three founders.

New appointee bios

Sarah Almond – VP of Translational Biology – brings three decades of scientific experience gained in biotechs and big pharma with a focus on CNS drug discovery. She has a strong record of advancing small-molecule programs from early discovery through IND and into clinical development. Most recently she was Head of Pharmacology at Astellas ESM-UK and prior to that at Mission Therapeutics supporting its Parkinson’s disease project into Phase I, guiding translational strategy and biomarker development. Earlier career experience includes at Charles River Laboratories, Takeda, AstraZeneca, and Merck. She has an BSc in Cell Physiology and Pharmacology from the University of Leicester and a MSc in Pharmacology and Toxicology from the University of Hertfordshire.

David Brocklebank – Director of Clinical Operations – is a clinical operations specialist with 37 years’ industry experience across all stages of clinical development including senior roles in Clinical Operations and Project Management at Shire Pharmaceuticals, Kissei Pharma Europe, Mitsubishi Tanabe, Takeda and Ono Pharma UK. Most recently he was Director, Clinical Operations at Kynos Therapeutics and prior to that at Outpost Medicine. In his early career he was a pharmacist in the NHS. He has a BPharm degree in Pharmaceutical Chemistry (Pharmacy) from the University of Bradford and an MRPharmS in Hospital Pharmacy from the Royal Pharmaceutical Society.

Kathryn Oliver – Director of Project Management – brings 15 years’ experience in biotech drug discovery and development having transitioned from a career as a medicinal chemist into project management. Gained experience in biotech project management at Macomics and RxCelerate following a period in the NHS. She has scientific research experience in industry from roles at Cellzome, Cambridge Biotechnology and UCB Pharma. She has an BSc in Chemistry with Industry from the University of Sheffield.

Media enquiries (for NRG Therapeutics)
Sue Charles, Charles Consultants – +44 7968 726585 sue@charles-consultants.com

About NRG Therapeutics – https://www.nrgtherapeutics.com

NRG Therapeutics is a neuroscience drug discovery company building a pipeline of disease-modifying mitochondrial therapeutics to slow or halt the progression of neurodegenerative disorders such as Parkinson’s and amyotrophic lateral sclerosis (ALS), also known as motor neurone disease (MND).

The company’s pre-clinical pipeline of small molecule assets is based on inhibiting the mitochondrial permeability transition pore (mPTP) through a novel mechanism of action. Inhibition of the mPTP has been shown to protect neurones, reduce neuroinflammation and improve motor function in pre-clinical disease models. Its lead asset, NRG5051, has completed IND-enabling studies and is on track to enter the clinic in early 2026.

Based at the Stevenage Bioscience Catalyst (SBC), UK, NRG Therapeutics is a private company with equity investment from Brandon Capital, British Business Bank, Criteria Bio Ventures, Dementia Discovery Fund, M Ventures, Novartis Venture Fund, Omega Funds and Parkinson’s UK. The company has also received awards from Innovate UK (Biomedical Catalyst Award), The Michael J. Fox Foundation, Target ALS and The ALS Association to support its innovative R&D programmes.

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Vantage Hemp Co. Strengthens Global Footprint with Initiation of European Regulatory Filings

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Vantage Hemp Co. Strengthens Global Footprint with Initiation of European Regulatory Filings




Vantage Hemp Co. Strengthens Global Footprint with Initiation of European Regulatory Filings

U.S. producer and WELDING GmbH & Co. KG partner to expand cannabinoid access in Europe

Greeley, Colorado, Oct. 23, 2025 (GLOBE NEWSWIRE) — Vantage Hemp Co. (“Vantage” or “the Company”), a globally accredited cannabinoid manufacturer, has initiated the submission process for its Certificate of Suitability (CEP) to the European Directorate for the Quality of Medicines (EDQM) and its Active Substance Master File (ASMF) to the European Medicines Agency (EMA). These applications place Vantage among the first global manufacturers pursuing formal regulatory recognition for hemp-derived active pharmaceutical ingredients (APIs) under Europe’s newly harmonized pharmacopoeial standard for cannabidiol (CBD).

To support access and distribution, Vantage has partnered with WELDING GmbH & Co. KG (“WELDING”), a family-owned life sciences company headquartered in Hamburg, Germany, with over 70 years of experience in pharmaceutical sourcing, registration, and supply chain management. Through WELDING’s established distribution network and Vantage’s internationally recognized manufacturing standards, the two companies can meet the demand for pharmaceutical-grade materials across the European Union, the European Economic Area, Switzerland, India, and North Macedonia.

The CEP and ASMF applications mark a significant milestone in advancing the Company’s position as a global CBD supplier. The CEP will confirm that Vantage’s CBD isolate meets all European pharmacopoeial quality standards, simplifying regulatory approvals and accelerating time-to-market for European pharmaceutical partners.

The ASMF will strengthen the Company’s leadership position by enabling pharmaceutical developers to use Vantage’s CBD isolate in finished drug formulations while protecting Vantage’s proprietary data. The process streamlines marketing authorization applications across Europe, providing a clear and compliant route for cannabinoid-based medicines.

“These filings will benefit companies wanting to develop CBD-based pharmaceuticals,” says Deepank Utkhede, Chief Operating Officer and Chief Process Biochemist at Vantage. “They enable us to expand into clinical and commercial applications, support our pharmaceutical partners with a clear regulatory path, and pave the way for pharmaceutical-grade CBD to be accessed safely, reliably, and consistently.”

Vantage and WELDING’s partnership builds on a recent wave of regulatory clarity across Europe. The introduction of harmonized pharmacopoeial standards in July 2024 and the issuance of the first European CEP for a CBD extract in early 2025 have established a clearer, faster, and more uniform path for pharmaceutical-grade cannabinoids.

Representatives from Vantage and WELDING will be attending CPHI Frankfurt 2025 to meet with existing and prospective partners to discuss ongoing regulatory developments and European expansion plans.

For partnership inquiries, please contact:
U.S. inquiries: Christian Santi, Vantage Hemp Co., christian@vantagehemp.com 
EU inquiries: Juan Pedro Vicente Vidal, WELDING GmbH & Co. KG, JuanPedro.VicenteVidal@welding.eu 


About Vantage Hemp Co.

Based in Greeley, Colorado, Vantage Hemp Co. is a global manufacturer of pharmaceutical-grade cannabinoid ingredients. Operating under FDA 21 CFR 210/211, ICH Q7, PIC/S, and WHO GMP standards, Vantage produces CBD and CBG APIs that meet international pharmacopeial specifications. The company’s operations are certified by Australia’s Therapeutic Goods Administration (TGA) and include active submissions with ANVISA (Brazil). Learn more: www.vantagehemp.com. 

About WELDING GmbH & Co. KG

WELDING GmbH & Co. KG, headquartered in Hamburg, is a family-owned company with over 70 years of international experience. The company specializes in the procurement and distribution of pharmaceutical active ingredients, food additives, and feed additives, as well as the development, approval, licensing, and delivery of generic pharmaceuticals. In this regard, WELDING also offers a comprehensive range of services in the field of quality assurance and regulatory affairs. Learn more: www.welding.eu

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CONTACT: For media inquiries, please contact:
Brooke Russell
Marigold PR
brussell@marigoldpr.com
905-510-3204

RECORDATI APPOINTS MIKE MCCLELLAN AS NEW CHIEF FINANCIAL OFFICER

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RECORDATI APPOINTS MIKE MCCLELLAN AS NEW CHIEF FINANCIAL OFFICER




RECORDATI APPOINTS MIKE MCCLELLAN AS NEW CHIEF FINANCIAL OFFICER

NEWS RELEASE

Milan, 23 October 2025 – Recordati, a global pharmaceutical company, announces today that Mike McClellan will join as its new Chief Financial Officer (CFO) as of January 1, 2026 and will be based in the Group’s headquarters in Milan.

Mike McClellan, an American national, is a seasoned CFO in the pharmaceutical industry with nearly 30 years of experience across various geographies. Most recently, he served as CFO of Almirall (2019-2025) where he played a pivotal role in delivering sustained growth and profitability, leading business development efforts, guiding key product launches and engaging with the investment community. Prior to that, Mr. McClellan served at Teva as Group CFO (2017-2019) and CFO Global Specialty Medicines (2015-2017). He also had a significant career at Sanofi where he served as CFO of North America (2012- 2015), CFO of Europe (2010-2012) as well as in several country CFO roles.

Rob Koremans, CEO of Recordati, commented: “We are delighted to welcome Mike as our incoming CFO following a thorough search process. Mike’s deep expertise and impressive achievements in the pharmaceutical industry will be instrumental as we continue to pursue our strategy of consistent growth, targeted business development/M&A, and meaningful engagement with all our stakeholders. I am confident that his passion and experience will ensure a smooth and successful transition. I would like to reiterate my gratitude to Luigi La Corte, who will step down in his current role as CFO at the end of the year and remain on the Board, for all his outstanding contributions and wish him well in his future endeavours.”

Mike McClellan, commenting on his appointment, stated: “I am truly pleased to join Recordati, a company with a strong track record of consistent financial performance, outstanding execution, and an excellent reputation in the industry. Having followed Recordati’s journey for many years, I have great respect for what the team has accomplished. I look forward to contributing to the next chapter and unlocking even more potential together in the years ahead.”

Based on the information available to the Company, Mike McClellan does not hold any shares in the Company.

Recordati is an international pharmaceutical group listed on the Italian Stock Exchange (XMIL: REC), with roots dating back to a family-run pharmacy in Northern Italy in the 1920s. We are uniquely structured to provide treatments across specialty and primary care, and rare diseases. Our fully integrated operations span clinical development, chemical and finished product manufacturing, commercialization and licensing. We operate in approximately 150 countries across EMEA, the Americas and APAC with over 4,500 employees. We believe that health is a fundamental right, not a privilege. Today, our purpose of “unlocking the full potential of life” aims at empowering individuals to live life to the fullest, whether addressing common health challenges or the rarest.

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.p.A.

Registered Office

Via Matteo Civitali, 1 20148 Milano, Italy
Tel. +39 02 487871
Fax +39 02 40073747
www.recordati.com

Share Capital € 26.140.644,50 fully paid-up
Milano, Monza, Brianza and Lodi Comp. Reg. No. 00748210150 Tax Code/VAT No. 00748210150
Milano R.E.A. No. 401832

Company subject to the Management and Coordination Activity of Rossini Luxembourg S.àr.l

Investor Relations

Eugenia Litz
+44 7824 394 750
Eugenia.Litz@recordati.com

Gianluca Saletta
+39 348 979 4876
saletta.g@recordati.it

Media Relations

ICR Healthcare US:
Alexis Feinberg
+1 203 939 2225
Alexis.feinberg@icrhealthcare.com

UK, Europe & Rest of World: Jessica Hodgson
+44 7561 424 788
jessica.hodgson@icrhealthcare.com

This document contains forward-looking statements relating to future events and future operating, economic and financial results of the Recordati group. By their nature, forward-looking statements involve risk and uncertainty because they depend on the occurrence of future events and circumstances. Actual results may therefore differ materially from those forecast for a variety of reasons, most of which are beyond the Recordati group’s control. The information on the pharmaceutical specialties and other products of the Recordati group contained in this document is intended solely as information on the activities of the Recordati Group, and, as such, it is not intended as a medical scientific indication or recommendation, or as advertising.

2

Further investment in Italy to provide cutting-edge diagnostics and patient experience

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SYNLAB

/ Key word(s): Strategic Company Decision

Further investment in Italy to provide cutting-edge diagnostics and patient experience

23.10.2025 / 09:00 CET/CEST

The issuer is solely responsible for the content of this announcement.

Further investment in Italy to provide cutting-edge diagnostics and patient experience

  • SYNLAB strengthens its commitment to care excellence in Italy by pioneering the installation of a photon-counting CT scanner at its Naples medical and research centre; this is one of the first systems of its kind available in Europe, offering the most advanced imaging technology today.
  • The new scanner enhances patient comfort and supports healthcare professionals with, faster, safer and more accurate diagnostics.

SYNLAB, a leader in medical diagnostic services and specialty testing in Europe, has reinforced its commitment to care excellence in Italy by pioneering the installation of a photon-counting CT scanner at its medical and research centre in Naples. This investment reflects the Group’s strategy of delivering best-in-class care excellence across its network.

Photon-counting CT marks one of the most significant advances in radiology in over a decade, offering next-generation imaging capabilities that transform both clinical outcomes and patient experience. Unlike conventional CT systems, it directly detects individual X-ray photons, enabling ultra-high-resolution imaging with markedly reduced radiation exposure and faster scan times. Integrated with advanced artificial intelligence, the new photon-counting CT scanner leverages deep learning algorithms to further enhance image quality, accelerate reporting, and support more accurate diagnostics.

This breakthrough technology allows clinicians to visualise anatomical structures with microscopic precision, supporting earlier and more accurate diagnoses in cardiovascular, neurological and oncological care and is particularly effective for complex cases such as coronary disease, tumour staging, and high-resolution lung studies. Designed with patient comfort in mind, the new scanner facilitates more streamlined procedures while equipping healthcare professionals with sharper, more actionable insights for timely and accurate decision-making.

SYNLAB Italy has invested over €9 million in advanced imaging diagnostics in 2024 and 2025, delivering more than 300,000 procedures this year alone.

This latest investment adds to SYNLAB’s recent opening of the SYNLAB Manifattura Firenze Medical Centre in Florence and follows a series of strategic acquisitions in the country. Together, these developments demonstrate SYNLAB’s long-term commitment to Italy and its ambition to be the diagnostic partner of choice for both patients and healthcare professionals.

“Our focus is on creating environments where patients feel safe, supported and well cared for,” said Iris Faull, Chief Medical Officer at SYNLAB Group. “At the same time, we are equipping healthcare professionals across disciplines with the most advanced tools available to deliver precise, efficient and high-quality diagnostics.”

Installing the photon-counting CT scanner in Naples is a significant step forward in offering innovative diagnostic solutions tailored to the needs of patients and healthcare professionals alike.

 

– Ends –

 

For more information:

Media contact:
Steffi Susan Kim, FTI Consulting		  
steffi.kim@fticonsulting.com
+49 (0) 171 5565 996
Investor contact: ir@synlab.com

 

About SYNLAB

  • SYNLAB Group is a leader in medical diagnostic services and specialty testing in Europe. The Group offers a full range of innovative and reliable medical diagnostics to patients, practising doctors, hospitals and clinics, governments, and corporates.
  • Providing the leading level of service within the industry, SYNLAB is the partner of choice for routine and specialty diagnostics in human medicine. The Group continuously innovates medical diagnostic services for the benefit of patients and customers.
  • SYNLAB operates in more than 20 countries across four continents and holds leading positions in most markets, regularly reinforcing the strength of its network through a proven acquisition strategy. More than 24,000 employees, including over 2,000 medical experts, contribute every day to the Group’s worldwide success.
  • SYNLAB performed around 600 million laboratory tests and achieved revenues of €2.62 billion in 2024.
  • More information can be found on www.synlab.com

23.10.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
View original content: EQS News

2217320  23.10.2025 CET/CEST

Heidelberg Pharma’s Lead ADC Candidate HDP-101 Granted Fast Track Designation by US FDA for the Treatment of Multiple Myeloma

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Heidelberg Pharma AG

/ Key word(s): Miscellaneous

Heidelberg Pharma’s Lead ADC Candidate HDP-101 Granted Fast Track Designation by US FDA for the Treatment of Multiple Myeloma

23.10.2025 / 07:57 CET/CEST

The issuer is solely responsible for the content of this announcement.

PRESS RELEASE

Heidelberg Pharma’s Lead ADC Candidate HDP-101 Granted Fast Track Designation by US FDA for the Treatment of Multiple Myeloma

  • Recognizes the potential of HDP-101 to address a serious or life-threatening condition with high unmet medical needs
  • Enables more frequent engagement with FDA and eligibility for rolling review to support expedited development and review

Ladenburg, Germany, 23 October 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical-stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced that HDP-101 (INN: pamlectabart tismanitin), the Company’s lead Amanitin-based ADC candidate, has been granted Fast Track Designation by the US Food and Drug Administration (FDA).

This designation was supported by nonclinical data as well as clinical data from the ongoing Phase I/IIa study with HDP-101 (INN: pamlectabart tismanitin), evaluating the safety and antitumor activity of the candidate in patients with relapsed or refractory multiple myeloma.

Professor Andreas Pahl, Chief Executive Officer of Heidelberg Pharma, commented: “The FDA’s granting of Fast Track Designation is fantastic news for Heidelberg Pharma and underscores the potential of HDP-101 for the treatment of severely ill and heavily pretreated patients. This designation will support our efforts to advance our lead ADC candidate efficiently toward patients with multiple myeloma who continue to face significant unmet medical needs.”

Fast Track Designation is intended to accelerate the development and review of therapies that address serious or life-threatening conditions with unmet medical needs. This status enables more frequent engagement with the FDA, allows Rolling Review of the Biologics License Application (BLA), and may provide eligibility for Priority Review or Accelerated Approval.

HDP-101 (INN: pamlectabart tismanitin) is an investigational product that has not yet received marketing approval by any regulatory authority, including the FDA. The safety and efficacy of this investigational compound is currently being evaluated and is not yet established.

About Heidelberg Pharma

Heidelberg Pharma is a biopharmaceutical company working on a new treatment approach in oncology and developing novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with cytotoxic compounds, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells.

Heidelberg Pharma is the first company to use the compound Amanitin from the green death cap mushroom in cancer therapy. The biological mechanism of action of the toxin represents a new therapeutic modality and is used as a compound in the Amanitin-based ADC technology, the so-called ATAC technology.

The lead candidate HDP-101 is a BCMA ATAC in clinical development for multiple myeloma. A second ATAC candidate, HDP-102, has recently started clinical development in Non-Hodgkin Lymphoma and is currently on a temporary hold. HDP-103 against metastatic castration-resistant prostate cancer and HDP-104 targeting gastrointestinal tumors such as colorectal cancer have completed preclinical development. Heidelberg Pharma is open for partnering.

The company is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com

ATAC® is a registered trademark of Heidelberg Pharma Research GmbH.

Contact
Heidelberg Pharma AG
Sylvia Wimmer
Director Corporate Communications
Tel.: +49 89 41 31 38-29
E-Mail: investors@hdpharma.com
Gregor-Mendel-Str. 22, 68526 Ladenburg		  
IR/PR-Support
MC Services AG
Katja Arnold (CIRO)
Managing Director & Partner
Tel.: +49 89 210 228-40
E-Mail: katja.arnold@mc-services.eu
International IR/PR-Support
Optimum Strategic Communications
Mary Clark, Zoe Bolt, Aoife Minihan
Tel: +44 20 3882 9621
Email: HeidelbergPharma@optimumcomms.com
 

This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will” “should” “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.

23.10.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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View original content: EQS News

Language: English
Company: Heidelberg Pharma AG
Gregor-Mendel-Str. 22
68526 Ladenburg
Germany
Phone: +49 (0)89 41 31 38 – 0
Fax: +49 (0)89 41 31 38 – 99
E-mail: investors@hdpharma.com
Internet: www.heidelberg-pharma.com
ISIN: DE000A11QVV0
WKN: A11QVV
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2217302

 
End of News EQS News Service

2217302  23.10.2025 CET/CEST

Galenica remains on growth track

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Galenica continued to grow in the third quarter of 2025 and generated sales of CHF 2,999.7 million to the end of September. Both the “Products & Care” segment (+5.0%) and “Logistics & IT” segment (+5.0%) contributed to the 4.7% increase in sales. 

This puts Galenica in line with the growth of the market; over the same period the pharmaceutical market2 grew 5.1% and the consumer healthcare market5 declined 0.4%.

In the first half of 2025 the Galenica Group achieved an increase in sales of 5.0%. A slight slowdown in growth was seen in the third quarter as expected due to the strong prior-year period. Growth continues to be driven by strong demand for prescription drugs, including GLP-1-based3 weight loss products as well as sales of dietary supplements.

The acquisition of the Labor Team Group, which was completed on 9 September 2025, also contributed to sales growth. Without this acquisition sales would have grown 4.4% to the end of the third quarter of 2025.

 

Guidance increased due to acquisition of Labor Team

The acquisition of Labor Team will increase the Group’s sales and earnings base. Galenica now expects sales growth of between 4% and 6% and an increase in EBIT1 of between 10% and 12%. The effects of acquisition-related amortization cannot yet be reliably quantified at this point and are not included in the EBIT1 guidance mentioned.

Excluding the additional contribution to sales and EBIT1 from the acquisition of Labor Team, Galenica confirms its previous 2025 outlook for consolidated net sales with growth of between 3% and 5% and an increase in EBIT1 of between 7% and 9%.

Galenica continues to plan to pay a dividend at least at the previous year’s level.

 

Net sales of the Galenica Group January – September 2025
 

(in million CHF)

Sept. 2025

Sept. 2024

Change

Products & Care segment

1,304.4

1,242.6

5.0%

Retail (B2C)

1,097.0

1,046.2

4.9%

Local Pharmacies

1,039.2

989.2

5.1%

Pharmacies at Home

58.0

57.2

1.3%

Professionals (B2B)

214.2

204.1

5.0%

Products & Brands

142.2

141.9

0.2%

Services for Professionals

72.1

62.2

15.9%

Logistics & IT segment

2,479.9

2,362.5

5.0%

Wholesale

2,375.4

2,262.8

5.0%

Logistics & IT Services

124.1

116.7

6.4%

Corporate and eliminations

-784.5

-740.2

 

Galenica Group

2,999.7

2,864.8

4.7%

 

“Products & Care” segment

Net sales in the “Products & Care” segment amounted to CHF 1,304.4 million to September 2025, equivalent to an increase of 5.0% over the previous year.

 

“Retail” business area (B2C)

The “Local Pharmacies” sector (excluding Coop Vitality) increased sales by 5.1% to CHF 1,039.2 million. The expansion effect on growth was 1.7%; the pharmacy network was expanded by five pharmacies net. Adjusted for this effect the sector grew organically by 3.4%, roughly in line with market growth when taking into account the product mix. As in previous months, sales of prescription medications contributed to the growth, not least due to persistently high demand for GLP-1-based3 weight loss products. Sales of dietary supplements contributed to growth too.

 

Demand for healthcare services in pharmacies also saw positive growth. Over 230,000 fee-based healthcare and consultation services were provided in the first nine months – an increase of 17% on the previous year4. The generic substitution rate at Galenica pharmacies remained high at 77.7% at the end of September 2025 (December 2024: 79.2%).

 

The “Pharmacies at Home” sector achieved sales growth of 1.3% to CHF 58.0 million. The negative growth effect of service adjustments was offset by strong growth of the Amavita and Sun Store online shops.

 

By way of comparison, drug sales from bricks-and-mortar pharmacies in Switzerland (prescription-only [Rx] and OTC products) grew 5.4%2 in the period under review, while the non-drugs segment of the consumer healthcare market contracted by -0.6% in the same period5.

 

“Professionals” business area (B2B)

Consumer healthcare market remains competitive. Galenica’s leading position in the Swiss market was further consolidated with sales growth of 4.6% to CHF 113.8 million. Sales growth is also being boosted by Cooper Consumer Health products, for which Verfora assumed sales responsibility at the start of the year.

 

Sales growth in Switzerland and the export business were negatively impacted by exceptionally high sales in the prior-year period. As a result, Verfora’s export business declined by -14.6%. By way of comparison, the consumer healthcare market contracted by -0.4%5 year on year.

 

The “Services for Professionals” business (+15.9%) grew significantly, in particular thanks to the inclusion of the Labor Team Group. Without the inclusion of Labor Team the business would have grown by 3.2%, with Lifestage Solutions and Medifilm once again driving growth with care homes and home care organisations.

 

“Logistics & IT” segment

The “Logistics & IT” segment generated net sales of CHF 2,479.9 million (+5.0%) in the first nine months of the 2025 financial year. This segment comprises Galenica’s logistics and IT platforms and offers services to healthcare providers.

 

“Wholesale” sector

The “Wholesale” sector generated net sales of CHF 2,375.4 million (+5.0%). Growth in the pharmacy business amounted to 5.4%, while growth of 4.4% was achieved in the wholesale business with physicians. This slightly outperformed market growth. By way of comparison, the overall pharmaceutical market grew by 5.1%2 in the reporting period; the physicians segment generated growth of 4.2%2, and the bricks-and-mortar pharmacy segment grew by 5.4%2. Overall market growth was supported by hospitals and mail-order pharmacies that are not core customers in the wholesale business.

 

“Logistics & IT Services” sector

The “Logistics & IT Services” sector performed as expected with growth of 6.4%, driven in particular by an increase in internal IT services. HCI Solutions also performed well, registering 375 million CDS Checks (+42%) on the Documedis® platform since the start of the year.

 

Additional information on sales and further information can be found in the Sales Presentation.

 

 

 

____________________________

1 Excluding the effects of IFRS 16 and IAS 19.

2 IQVIA, Pharmaceutical Market Switzerland, YTD September 2025.

3 GLP-1 stands for glucagon-like peptide 1, a hormone produced in the intestine, and plays an important role in regulating blood sugar levels.

4 New calculation methodology covering all advisory services, including vaccinations and other services such as preventive health checks. The previous year’s figure was also adjusted.

5 IQVIA, Consumer Health Market Switzerland, YTD September 2025.

 

Lonza Delivers a Strong Q3 2025 and Confirms Full-Year 2025 Outlook for its CDMO and CHI Businesses

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  • Strong CDMO1 performance in Q3 2025 in Integrated Biologics and Advanced Synthesis, while Specialized Modalities improved versus a soft H1
  • Large contract signings in Q3, including another significant commercial contract for Vacaville
  • Capsules & Health Ingredients (CHI) returned to growth as expected and in line with Full-Year Outlook
  • CDMO Outlook for Full-Year 2025 confirmed: upgraded at Half-Year to CER sales growth of 20-21% and a CORE EBITDA margin of 30-31%

Basel, Switzerland, 23 October 2025 – In its Q3 2025 qualitative update, Lonza reported a strong CDMO performance in line with its upgraded Full-Year Outlook. Capsules & Health Ingredients (CHI) progressed on its expected recovery path and returned to growth in line with its Full-Year 2025 Outlook. 

Lonza saw strong momentum in Integrated Biologics based on continuing robust demand for large-scale mammalian assets, further supported by the Vacaville (US) acquisition. Advanced Synthesis continued to experience strong commercial demand for its Bioconjugates and Small Molecules offerings, supported by successful growth project ramp-ups. Specialized Modalities improved in Q3 as expected. Full-Year 2025 performance is expected to remain moderate in the context of the softer H1. Efforts aimed at strengthening the resilience of the Business Platform are ongoing and will take time to materialize. In line with the expected recovery path, CHI returned to positive CER growth, supported by higher volumes in the pharmaceutical capsules business. Additionally, CHI’s strong manufacturing presence in the US is continuing to support customers in navigating the evolving US tariff environment.

In 2025, Lonza expects a healthy level of contract signings across technologies and sites within its CDMO business. In Q3, Lonza signed a further significant strategic long-term contract for integrated drug substance and drug product supply of bioconjugates. In its Small Molecules Technology Platform, Lonza signed a large multi-year commercial supply agreement. Furthermore, Lonza’s large-scale mammalian site in Vacaville experienced sustained high customer interest, including the signing of a significant long-term commercial supply agreement. Further signings in Vacaville are expected in the coming months. 

One year after closing the Vacaville acquisition, the site’s integration into Lonza’s global network is progressing fully in line with plan. The site shows strong and consistent operational execution, maintaining its excellent quality track record while advancing preparations for new product introductions. The first phase of capital expenditure is progressing as planned, with additional investments to follow in the next two to three years to upgrade the site’s automation system and multi-purpose capabilities. 

Ramp-up activities at Lonza’s highly potent API2 (HPAPI) plant in Visp (CH) are progressing well, and full commercial operations commenced in July 2025. The newly constructed large-scale mammalian drug substance facility, also located in Visp, showed good progress in ramp-up activities in line with plan, with GMP operations underway and commercial production set to ramp up gradually from 2026 onwards. 

In the evolving geopolitical and macroeconomic environment, Lonza expects no material financial impact from the currently announced US trade policies but continues to monitor the situation closely. Lonza remains confident that its well-diversified global manufacturing footprint, which includes a strong presence with large capacities in the US, will enable it to support its customers’ global manufacturing requirements. 

Lonza is monitoring biotech funding trends and regulatory shifts in the US. In its early-stage business, Lonza saw a continued high level of utilization in Q3, with good visibility for the coming months. With such early-stage activities representing just approximately 10% of the CDMO business, fluctuations in biotech funding are expected to have only a minimal impact on Lonza’s future performance.

In Q3, Lonza made good progress with the necessary internal carve-out measures to prepare the exit from the CHI business in the best interests of customers, employees and shareholders at the appropriate time. The positive development of the business over the last months remained unaffected by the exit preparations.

Outlook 2025 confirmed

Supported by a strong performance in Q3 2025, Lonza confirms its Full-Year 2025 Outlook for its CDMO and CHI businesses.

The CDMO business is well on track to deliver higher sales in H2 than in H1 and a healthy progression of the CORE EBITDA in line with the 2025 Outlook, which was upgraded with the Half-Year 2025 results to CER sales growth of 20-21% (previously “approaching 20%”) and a CORE EBITDA margin of 30-31% (previously “approaching 30%”). Excluding Vacaville, which is expected to contribute at the upper-end of the range of around half a billion CHF in sales at a better than expected margin in 2025, Lonza expects low-teens percentage organic CER sales growth and margin improvement in its CDMO business in line with its CDMO Organic Growth Model. 

Supported by its return to growth, Lonza confirms the Full-Year 2025 Outlook for its CHI business, with low-to-mid single-digit percentage CER sales growth and an improved CORE EBITDA margin in the mid-twenties. 

Assuming spot rates of early October 2025 will prevail for the remainder of the year, Lonza reiterates an anticipated FX3 headwind of approximately -2.5 to -3.5% on sales and CORE EBITDA, mainly attributed to the weakening of the US Dollar. Margins will be minimally impacted, thanks to a robust natural hedge and Lonza’s financial hedging program.

argenx to Report Third Quarter 2025 Financial Results and Business Update on October 30, 2025

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argenx to Report Third Quarter 2025 Financial Results and Business Update on October 30, 2025




argenx to Report Third Quarter 2025 Financial Results and Business Update on October 30, 2025

October 23, 2025

Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will host a conference call and audio webcast on Thursday, October 30, 2025 at 1:30 PM CET (8:30 AM ET) to discuss its third quarter 2025 financial results and provide a business update.

A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately one year following the presentation.

Dial-in numbers:

Belgium                32 800 50 201
France                        33 800 943355
Netherlands                31 20 795 1090
United Kingdom        44 800 358 0970
United States                1 888 415 4250
Japan                        81 3 4578 9081
Switzerland                41 43 210 11 32

Use the access code 3810049 to join the call. Please dial in 15 minutes prior to the live call.

About argenx

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Instagram, Facebook, and YouTube.

Contacts

Media:

Ben Petok
bpetok@argenx.com

Investors:

Alexandra Roy
aroy@argenx.com

argenx to Report Third Quarter 2025 Financial Results and Business Update on October 30, 2025

Posted on by

argenx to Report Third Quarter 2025 Financial Results and Business Update on October 30, 2025




argenx to Report Third Quarter 2025 Financial Results and Business Update on October 30, 2025

October 23, 2025

Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will host a conference call and audio webcast on Thursday, October 30, 2025 at 1:30 PM CET (8:30 AM ET) to discuss its third quarter 2025 financial results and provide a business update.

A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately one year following the presentation.

Dial-in numbers:

Belgium                32 800 50 201
France                        33 800 943355
Netherlands                31 20 795 1090
United Kingdom        44 800 358 0970
United States                1 888 415 4250
Japan                        81 3 4578 9081
Switzerland                41 43 210 11 32

Use the access code 3810049 to join the call. Please dial in 15 minutes prior to the live call.

About argenx

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Instagram, Facebook, and YouTube.

Contacts

Media:

Ben Petok
bpetok@argenx.com

Investors:

Alexandra Roy
aroy@argenx.com

[Ad hoc announcement pursuant to Art. 53 LR] Roche continues strong sales growth momentum of 7% (CER) in the first nine months of 2025; full-year earnings outlook raised

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[Ad hoc announcement pursuant to Art. 53 LR] Roche continues strong sales growth momentum of 7% (CER) in the first nine months of 2025; full-year earnings outlook raised




[Ad hoc announcement pursuant to Art. 53 LR] Roche continues strong sales growth momentum of 7% (CER) in the first nine months of 2025; full-year earnings outlook raised


Basel, 23 October 2025 

  • Group sales grew by 7%1 at constant exchange rates (CER; 2% in CHF) in the first nine months, driven by high demand for our innovative medicines and diagnostics.
  • Pharmaceuticals Division sales rose by 9% (4% in CHF) due to continued high growth in sales of medicines for the treatment of severe diseases; Phesgo (breast cancer), Xolair (food allergies), Hemlibra (haemophilia A), Vabysmo (serious eye diseases) and Ocrevus (multiple sclerosis) were the top growth drivers.
  • Diagnostics Division sales increased by 1% (-4% in CHF) as demand for pathology solutions and molecular diagnostics more than offset the impact of healthcare pricing reforms in China.
  • Highlights:
    • US approval for Tecentriq combination for a form of lung cancer and Gazyva/Gazyvaro for a severe kidney disease
    • EU CE mark for Contivue, a port delivery platform with Susvimo*, for a severe eye disease
    • Positive EU CHMP recommendation for the subcutaneous formulation of Lunsumio for a type of blood cancer and for Gazyva/Gazyvaro for a severe kidney disease
    • Positive data from phase III study on giredestrant in breast cancer, phase II open-label extension study on fenebrutinib in multiple sclerosis, phase I/II study on trontinemab in Alzheimer’s disease and long-term follow-up studies on Vabysmo and Susvimo in a severe age-related eye disease
    • Advancement of several key drug candidates into phase III trials: zilebesiran for uncontrolled hypertension, CT-388 for obesity, CT-868 for type 1 diabetes, cevostamab for a difficult-to-treat form of blood cancer and ZN-1041 for a type of breast cancer
    • Announcement of a merger agreement to acquire 89bio and its phase III FGF21 analogue for the treatment of moderate to severe metabolic dysfunction-associated steatohepatitis (MASH), a form of fatty liver disease that is one of the most prevalent comorbidities of obesity
    • EU CE mark and US approval for the Elecsys pTau181, the only FDA-cleared blood test for use in primary care to rule out Alzheimer’s disease-related amyloid pathology
    • EU CE mark for the first AI-based risk stratification tool to assess progressive decline in kidney function and for the sixth-generation Troponin T test, which shows a new level of accuracy critical in diagnosing heart attacks
  • Outlook for 2025 earnings raised.

Roche CEO Thomas Schinecker: “We continue to build on our positive momentum with strong sales growth of 7% at constant exchange rates.

Our momentum is further reflected in our pipeline with a number of positive clinical read-outs and a record ten potentially transformative medicines progressing into the final phase of development for diseases with significant unmet need. By the end of the decade, we expect phase III clinical results for up to 19 new medicines.

Our groundbreaking next-generation sequencing technology, set to launch next year, has achieved a new record for decoding a whole human genome in under four hours.

Based on our strong results, we are raising our earnings outlook for the full year.”

Sales CHF millions As % of sales % change
January–September 2025 2024 2025 2024 At CER In CHF
Group 45,862 44,984 100.0 100.0 7 2
             
Pharmaceuticals Division 35,555 34,257 77.5 76.2 9 4
United States 18,798 18,166 41.0 40.4 8 3
Europe 6,818 6,613 14.9 14.7 5 3
Japan 2,139 2,083 4.7 4.6 5 3
International** 7,800 7,395 16.9 16.5 13 5
             
Diagnostics Division 10,307 10,727 22.5 23.8 1 -4

**Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others

Outlook for 2025 earnings raised
Roche (SIX: RO, ROG; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER). Core earnings per share are targeted to develop in the high single to low double digit range (CER). Roche expects to further increase its dividend in Swiss francs.

Group sales
In the first nine months of 2025, Roche achieved sales growth of 7% (2% in CHF) to CHF 45.9 billion due to strong demand for our pharmaceutical and diagnostic products.

The appreciation of the Swiss franc against most currencies, notably the US dollar, had an adverse impact on sales when reported in Swiss francs compared to constant exchange rates.

Sales in the Pharmaceuticals Division increased by 9% (4% in CHF) to CHF 35.6 billion, with medicines for severe diseases continuing their strong growth.

The top five growth drivers – Phesgo, Xolair, Hemlibra, Vabysmo and Ocrevus – achieved total sales of CHF 15.8 billion. This represents an increase of CHF 2.4 billion at CER compared to the first nine months of 2024.

This increase more than compensated for the total decrease of CHF 0.5 billion (CER) in sales of the ‘loss of exclusivity (LOE)’ products – the decline in sales of Avastin (various types of cancer), Herceptin (breast and gastric cancer), MabThera/Rituxan (blood cancer, rheumatoid arthritis), Lucentis (severe eye diseases) and Esbriet (lung disease) was partially offset by an increase in sales of Actemra/RoActemra (rheumatoid arthritis).

In the United States, sales rose by 8% due to growth in sales of Xolair, Phesgo, Ocrevus, Hemlibra, Polivy (blood cancer) and Vabysmo. This growth more than compensated for the decline in sales of medicines with expired patents.

Sales in Europe grew 5% as strong demand for Ocrevus and Vabysmo and the continuing uptake of Polivy, Phesgo and Hemlibra more than compensated for the lower sales of Perjeta (breast cancer) due to ongoing conversion of patients to Phesgo and the impact of biosimilar competition on Actemra/RoActemra sales.

In Japan, sales increased by 5%, mainly due to the strong uptake of Phesgo, Hemlibra, Vabysmo and PiaSky (paroxysmal nocturnal haemoglobinuria). Sales growth was partially offset by the decline in sales of Perjeta due to continued conversion of patients to Phesgo and of Avastin because of biosimilar erosion.

Sales in the International region grew by 13%, led by Phesgo, Hemlibra, Vabysmo, Xofluza (influenza) and Kadcyla (breast cancer). In China, sales rose by 9%, driven by the uptake of Phesgo due to inclusion in the government drug reimbursement list, strong sales of Xofluza and the continued roll-out of Polivy and Vabysmo.

The Diagnostics Division’s sales increased by 1% (-4% in CHF) to CHF 10.3 billion as growth in demand for pathology solutions and molecular diagnostics more than offset the impact of healthcare pricing reforms in China.

Sales in the Europe, Middle East and Africa (EMEA) region increased by 6%, driven by higher sales of clinical chemistry and immunodiagnostic products. In North America, sales increased by 7%, with growth across customer areas. Sales in Asia-Pacific decreased by 15% due to healthcare pricing reforms in China. Latin America sales grew by 14%.

Pharmaceuticals: key developments

Compound Milestone
Regulatory
Gazyva/ Gazyvaro

Blood cancer

FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis

  • The FDA approval is based on the superiority of Gazyva/Gazyvaro over standard therapy alone, as shown by the phase II NOBILITY and phase III REGENCY data
  • Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study
  • Lupus nephritis affects more than 1.7 million people worldwide, predominantly women of colour and childbearing age, with up to one-third of patients progressing to end-stage kidney disease

 More information: Media Release, 20 October 2025

Gazyva/ Gazyvaro

Blood cancer

CHMP recommends EU approval of Roche’s Gazyva/Gazyvaro for lupus nephritis

  • The positive recommendation is based on phase II NOBILITY and phase III REGENCY data showing the superiority of Gazyva/Gazyvaro over standard therapy alone
  • Gazyva/Gazyvaro is the only anti-CD20 antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study
  • Lupus nephritis is a debilitating condition that severely impacts a person’s quality of life and affects more than 1.7 million people worldwide

 

More information: Media Release, 17 October 2025

Tecentriq

Lung cancer

FDA approves Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer (ES-SCLC)

  • The combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study
  • This is the first and only combination therapy for the first-line maintenance treatment of ES-SCLC, which is critical to help address the high rate of relapse in ES-SCLC
  • The regimen is recommended in the National Comprehensive Cancer Network Guidelines for SCLC

More information: Media Release, 3 October 2025

Lunsumio

Blood cancer

CHMP recommends EU approval of subcutaneous formulation of Lunsumio for people with relapsed or refractory follicular lymphoma

  • Lunsumio provides high and long-lasting response rates, with approximately two-thirds of patients with a complete response in remission after four years
  • Subcutaneous Lunsumio has the potential to substantially reduce treatment administration time with an injection of approximately one minute, compared with an IV infusion of two to four hours
  • If approved, Lunsumio would be the first treatment available for people with follicular lymphoma after two or more lines of systemic therapy, which is both fixed-duration and subcutaneously administered

More information: Media Release, 19 September 2025

Susvimo

Severe eye diseases

Roche receives CE mark for Contivue, its port delivery platform with Susvimo, for neovascular or ‘wet’ age-related macular degeneration (nAMD)

  • Susvimo is under review with the EMA and once approved, will be the first continuous delivery treatment for nAMD, affecting 1.7 million in the European Union
  • New seven-year data from the LADDER study show Contivue with Susvimo provides good visual outcomes with stable retinal anatomy over the longer term
  • With up to two refills per year, Contivue with Susvimo provides reliable, long-term vision outcomes and is approved in the US for nAMD, diabetic macular edema (DME) and diabetic retinopathy (DR)

More information: Media Release, 4 September 2025

Elevidys

Duchenne muscular dystrophy

Regulatory update on Elevidys gene therapy for Duchenne muscular dystrophy (DMD) in the EU

  • EMA’s CHMP issued an opinion not to recommend Elevidys for the treatment of ambulatory individuals with DMD
  • Roche will continue its dialogue with the EMA to explore a potential path forward to make Elevidys available to individuals living with DMD in the EU
  • Roche believes the benefit-risk remains positive in the ambulatory DMD population
  • Elevidys is the first and only disease-modifying gene therapy for DMD 

More information: Media Release, 25 July 2025

Phase III, pivotal and other key read-outs
Tecentriq

Bladder cancer

Tecentriq showed significant overall and disease-free survival benefits in bladder cancer with ctDNA-guided treatment

  • Tecentriq reduced the risk of death by 41% and the risk of disease recurrence or death by 36% compared with placebo
  • IMvigor011 is the first global phase III study to read out a pioneering ctDNA-guided approach to post-surgery treatment in muscle-invasive bladder cancer
  • Data was presented as part of the Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2025

More information: Media Release, 20 October 2025

Giredestrant

Breast cancer

Phase III evERA data showed that giredestrant significantly improved progression-free survival in people with ER-positive advanced breast cancer

  • Giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in the intent-to-treat (ITT) and ESR1-mutated populations, respectively, in a post-CDK inhibitor setting, compared with standard-of-care endocrine therapy plus everolimus
  • The giredestrant combination was well tolerated; no new safety signals were observed including no photopsia
  • If approved, giredestrant plus everolimus could be the first and only oral selective oestrogen receptor degrader combination in the post-CDK inhibitor setting

More information: Media Release, 18 October 2025

Vamikibart

Severe eye disease

Roche presents new phase III pivotal data for vamikibart in uveitic

macular edema (UME), a serious cause of vision loss

  • Vamikibart is the first non-steroid targeted therapy designed to address inflammation driving UME and may offer a potential new treatment option for patients
  • Vision improvements were seen in both pivotal studies, achieving statistical significance in MEERKAT and nominal significance in SANDCAT
  • The MEERKAT and SANDCAT trials are ongoing and the data will be discussed with health authorities globally

More information: Media Release, 17 October 2025

Ocrevus/ Fenebrutinib

Multiple sclerosis

 

 

Roche presents new data for Ocrevus and fenebrutinib across broad patient populations at the 2025 Conference of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)

  • Ocrevus subcutaneous maintains a consistent benefit-risk profile after two years
  • New late-breaking data confirm that Ocrevus significantly reduces disability progression in adults with advanced primary progressive multiple sclerosis (PPMS)
  • One-year data reinforce that the majority of infants potentially exposed to Ocrevus during pregnancy or breastfeeding exhibit antibody responses
  • Fenebrutinib two-year phase II data demonstrate near-complete suppression of disease activity at 96 weeks

More information: Media Release, 24 September 2025

Giredestrant

Breast cancer

Positive phase III results show giredestrant significantly improved progression-free survival in ER-positive advanced breast cancer

  • evERA met its co-primary endpoints; giredestrant plus everolimus demonstrated significant benefit in intent-to-treat (ITT) and ESR1-mutated populations in the post-CDK inhibitor setting, compared with standard of care plus everolimus
  • The all-oral combination was well tolerated and adverse events were consistent with the known safety profiles of the individual study treatments; no new safety signals were observed
  • evERA is the first positive head-to-head phase III trial investigating an all-oral selective oestrogen receptor degrader-containing regimen versus a standard of care combination

More information: Media Release, 22 September 2025

Vabysmo

Severe eye diseases

New data for Vabysmo reinforce its efficacy, safety and durability in neovascular or ‘wet’ age-related macular degeneration (nAMD)

  • In AVONELLE-X, the largest long-term extension trial in nAMD, disease control and durability were maintained over four years, with nearly 80% of patients on extended dosing by study end
  • Over 60% of people with a difficult-to-treat form of nAMD showed no signs of damaging lesions in the SALWEEN study, and clinically meaningful vision improvements were observed
  • Vabysmo was well tolerated with a consistent long-term safety profile in nAMD in both studies

More information: Media Release, 5 September 2025

Susvimo

Severe eye diseases

Susvimo maintains vision over five years with two refills per year in people with neovascular age-related macular degeneration (nAMD)

  • Susvimo is the only continuous delivery treatment to provide reliable, long-term vision outcomes in nAMD, the leading cause of vision loss in people over the age of 60
  • With two refills per year, Susvimo maintained vision and stabilised the retina for five years, with durability maintained in approximately 95% of patients
  • Susvimo was well tolerated over five years and has a well-characterised safety profile

 More information: Media Release, 1 August 2025

Trontinemab

Alzheimer’s disease

Roche presents new insights in Alzheimer’s disease research across its diagnostics and pharmaceuticals portfolios at the Alzheimer’s Association International Conference (AAIC)

  • Trontinemab’s phase Ib/IIa Brainshuttle AD study continues to show rapid and robust clearance of amyloid plaques, with 91% becoming amyloid PET negative and ARIA-E remaining <5%
  • Design of the phase III TRONTIER 1 and 2 studies of trontinemab in early symptomatic Alzheimer’s disease featured, with initiation planned in 2025
  • Plans for new phase III trial investigating trontinemab in preclinical Alzheimer’s disease, in people at high risk of cognitive decline
  • New real-world data support Elecsys pTau217 as a stand-alone blood test, comparable to a PET scan, for rule-in and rule-out identification of amyloid pathology 

More information: Media Release, 28 July 2025

Other
Data at ESMO Roche data presented at the European Society for Medical Oncology (ESMO) Congress 2025 showcase advances in science and cancer care across multiple tumour types

  • Roche presented more than 30 abstracts across more than 10 cancer types at the ESMO Congress 2025, held 17‒21 October 2025 in Berlin, Germany
  • The data underscore Roche’s commitment to deliver transformative medicines for some of the most challenging cancer types, including breast cancers, lung cancers, gastrointestinal and genitourinary cancers

More information: Media Release, 13 October 2025

Change in Board of Directors Change in the Roche Board of Directors

  • Dr Claudia Suessmuth Dyckerhoff has decided not to stand for re-election as a member of the Roche Board of Directors at the Annual General Meeting in 2026
  • She will be nominated for election to the board of another company which is serving the healthcare industry
  • Dr Claudia Suessmuth Dyckerhoff has served on the Roche Board of Directors since March 2016

More information: Media Release, 3 October 2025

89bio tender offer Roche commences tender offer for all shares of 89bio, Inc. for USD 14.50 per share in cash, plus a non-tradeable contingent value right for up to USD 6.00 per share in cash

  • The tender offer is being made pursuant to the previously announced merger agreement dated as of 17 September 2025, among Roche Holdings, Inc., an indirect wholly owned subsidiary of Roche Holding Ltd, Bluefin Merger Subsidiary, Inc., a wholly owned subsidiary of Roche Holdings, Inc., and 89bio
  • The tender offer period will expire at one minute after 11:59 p.m., New York City time on 29 October 2025, unless the offer is extended 

More information: Media Release, 1 October 2025

89bio merger agreement Roche enters into a definitive merger agreement to acquire 89bio and its phase III FGF21 analogue for the therapy of moderate to severe metabolic dysfunction-associated steatohepatitis (MASH)

  • 89bio’s pegozafermin allows for a potentially best-in-disease treatment for moderate to severe MASH, one of the most prevalent comorbidities of obesity
  • The acquisition supports Roche’s strategy as it enhances the company’s portfolio in cardiovascular, renal and metabolic diseases and offers optionality for future combination development
  • Roche will acquire 89bio for USD 14.50 per share in cash at closing, representing a total equity value of approximately USD 2.4 billion. Stockholders would also receive a non-tradeable contingent value right for up to an aggregate of USD 6.00 per share in cash, representing a total deal value of up to approximately USD 3.5 billion

More information: Media Release, 18 September 2025

Zilebesiran

Hypertension

Roche and Alnylam advance zilebesiran into a global phase III cardiovascular outcomes trial for people with uncontrolled hypertension

  • Phase III trial informed by comprehensive KARDIA data set generated through three phase II studies: KARDIA-1, KARDIA-2 and KARDIA-3
  • In the phase II KARDIA-3 study, presented as a late breaker at the European Society of Cardiology Congress 2025, zilebesiran demonstrated clinically meaningful reductions in office systolic blood pressure at month three with continuous control through month six
  • Zilebesiran, a potential best-in-disease RNAi anti-hypertensive with twice-yearly subcutaneous dosing, demonstrated encouraging safety when combined with two or more antihypertensives

More information: Media Release, 30 August 2025

North Carolina manufacturing facility Roche’s US subsidiary Genentech breaks ground on state-of-the-art manufacturing facility in North Carolina, USA

  • The USD 700 million project is part of Roche’s USD 50 billion investment in US manufacturing, infrastructure and R&D
  • The facility will create more than 1,900 jobs and support the production of next-generation metabolic medicines, including treatments for obesity
  • These investments underscore Roche’s commitment to innovative manufacturing, designed to bring life-changing treatments to patients faster 

More information: Media Release, 25 August 2025

Pharmaceuticals sales

Sales CHF millions As % of sales % change
January–September 2025 2024 2025 2024 At CER In CHF
Pharmaceuticals Division 35,555 34,257 100.0 100.0 9 4
United States 18,798 18,166 52.9 53.0 8 3
Europe 6,818 6,613 19.2 19.3 5 3
Japan 2,139 2,083 6.0 6.1 5 3
International 7,800 7,395 21.9 21.6 13 5

International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others

Top 20 best-selling pharmaceuticals Total United States Europe Japan International
CHF m % CHF m % CHF m % CHF m % CHF m %
Ocrevus
Multiple sclerosis 		5,190 7 3,613 4 1,060 12 – – 517 24
Hemlibra
Haemophilia A 		3,526 12 1,941 7 740 9 275 9 570 45
Vabysmo
Eye diseases (nAMD, DME, RVO) 		3,063 13 2,139 4 556 24 105 26 263 115
Tecentriq
Cancer immunotherapy 		2,616 1 1,222 -3 650 2 262 -3 482 15
Perjeta2
Breast cancer 		2,316 -13 968 -2 418 -15 54 -39 876 -19
Xolair2
Asthma, food allergies 		2,226 34 2,226 34 – – – – – –
Actemra/RoActemra2
RA, COVID-19 		1,893 2 926 2 450 -10 230 5 287 19
Phesgo
Breast cancer 		1,827 54 523 35 602 13 139 63 563 193
Kadcyla2
Breast cancer 		1,531 8 577 5 396 -6 68 -2 490 28
Evrysdi
Spinal muscular atrophy 		1,293 8 468 14 450 5 68 6 307 5
Alecensa
Lung cancer 		1,190 8 420 18 197 -8 151 8 422 7
Polivy
Blood cancer 		1,101 40 497 27 228 63 153 10 223 94
MabThera/Rituxan2
Blood cancer, RA 		933 -4 575 -2 104 -2 11 -11 243 -9
Activase/TNKase2
Cardiac diseases 		833 -2 797 -2 – – – – 36 -13
Herceptin2
Breast and gastric cancer 		817 -19 175 -9 223 0 6 -46 413 -29
Avastin2
Various cancer types 		763 -15 225 -19 54 -14 111 -23 373 -10
Gazyva/Gazyvaro2
Blood cancer 		728 13 376 18 183 1 25 20 144 17
Pulmozyme2
Cystic fibrosis 		361 16 254 25 49 -10 – -8 58 8
CellCept2
Immunosuppressant 		292 7 14 -11 97 22 34 28 147 -2
Madopar2
Parkinson’s disease 		273 3 – – 70 -3 – – 203 6

DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis

Diagnostics: key developments

Product Milestone
Kidney Klinrisk Algorithm

Kidney disease

Roche receives CE Mark for AI-based Kidney Klinrisk Algorithm and launches new comprehensive chronic kidney disease (CKD) algorithm panel

  • Roche, in collaboration with KlinRisk, Inc, has received CE-mark for the first AI-based risk stratification tool for assessment of progressive decline in kidney function
  • This tool will be launched as part of Roche’s new chronic kidney disease (CKD) algorithm panel to support care across the stages of the disease which affects 700 million people globally
  • Clinicians can use the CKD panel (Kidney Klinrisk Algorithm and Kidney KFRE Algorithm) to evaluate a patient’s risk of kidney function decline, including in the early asymptomatic stages of the disease

More information: Media Release, 6 October 2025

Troponin T test

Heart attacks

Data show Roche’s sixth-generation Troponin T test offers a new level of accuracy critical for diagnosing heart attacks

  • Recently granted CE Mark, the novel test delivers improved sensitivity and accuracy for faster and more reliable diagnosis in emergencies
  • The test helps clinicians quickly identify heart attack and rule out non-cardiac causes, ensuring patients receive the care they need at the earliest opportunity
  • The global TSIX clinical study involved more than 13,000 participants, validating performance across a diverse population that reflects real-world healthcare settings 

More information: Media Release, 30 September 2025

Elecsys pTau181

Alzheimer’s disease

Roche receives CE Mark for minimally invasive blood test to help rule out Alzheimer’s disease

  • Elecsys pTau181 is the first In Vitro Diagnostic Regulation (IVDR)-certified test to rule out Alzheimer’s-associated amyloid pathology
  • The minimally invasive blood-based test can serve as a rule-out for Alzheimer’s pathology, reducing the need for confirmatory testing with a negative result
  • Data from clinical study supports use in primary care for people with varying signs of cognitive decline 

More information: Media Release, 23 July 2025

Diagnostics sales

Sales CHF millions As % of sales % change
January–September 2025 2024 2025 2024 At CER In CHF
Diagnostics Division 10,307 10,727 100.0 100.0 1 -4
Customer areas3            
Core Lab 5,688 6,057 55.2 56.5 -1 -6
Molecular Lab 1,861 1,876 18.1 17.5 4 -1
Near Patient Care 1,477 1,611 14.3 15.0 -4 -8
Pathology Lab 1,281 1,183 12.4 11.0 13 8
Regions            
Europe, Middle East, Africa 3,686 3,589 35.8 33.5 6 3
North America 3,305 3,222 32.1 30.0 7 3
Asia-Pacific 2,547 3,146 24.7 29.3 -15 -19
Latin America 769 770 7.4 7.2 14 0

More information on Roche performance in the first nine months of 2025:

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. 

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Unless otherwise stated, all growth rates and comparisons to the previous year in this document are at constant exchange rates (CER: average rates 2024) and all total figures quoted are reported in CHF.
[2] Products launched before 2015.
[3] Core Lab: diagnostics solutions in the areas of immunoassays, clinical chemistry and CustomBiotech.
Molecular Lab: diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics, genomic tumour profiling.
Near Patient Care: diagnostics solutions in emergency rooms, medical practices and directly with patients, including integrated personalised diabetes management.
Pathology Lab: diagnostics solutions for tissue biopsies and companion diagnostics.
In 2025, sales in the Pathology Lab customer area include sales previously reported in the Molecular Lab customer area to foster business transparency and harmonisation in the use of solutions in the area of cervical intraepithelial neoplasia technology (CINtec). The comparative information for 2024 has been restated accordingly.
In 2025, sales in the Core Lab customer area include sales previously reported in the Near Patient Care customer area to centralise digital healthcare solutions within Roche Information Solutions. The comparative information for 2024 has been restated accordingly.
* Susvimo is approved in the US by the Food and Drug Administration (FDA) for nAMD, diabetic macular edema (DME) and diabetic retinopathy (DR). It is currently under review with the European Medicines Agency (EMA) for the treatment of nAMD.

Cautionary statement regarding forward-looking statements
This document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche.

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