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




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 LinkedInInstagramFacebook, 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

[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.

Roche Global Media Relations
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Phone: +41 79 407 72 58
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Phone: +41 79 771 05 25
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Phone: +41 79 568 24 95
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Phone: +44 797 32 72 915
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Phone: +49 172 636 72 62
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Phone: +41 79 961 92 50
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Phone: +41 79 205 27 03
 

Roche Investor Relations

Dr Bruno Eschli
Phone: +41 61 687 52 84
e-mail: bruno.eschli@roche.com
Dr Sabine Borngräber
Phone: +41 61 688 80 27
e-mail: sabine.borngraeber@roche.com 
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Investor Relations North America

Loren Kalm
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Attachments

Cannabix Technologies announces Stock Option Grant

Cannabix Technologies announces Stock Option Grant




Cannabix Technologies announces Stock Option Grant

VANCOUVER, British Columbia, Oct. 22, 2025 (GLOBE NEWSWIRE) — Cannabix Technologies Inc. (CSE: BLO) (OTC PINK: BLOZF) (Frankfurt: 8CT) (the “Company or Cannabix”) reports it has granted 2,500,000 incentive stock options (“the Options”) to certain directors and consultants of the Company, exercisable at $0.55. 700,000 of the Options will expire in five years from the date of grant, 800,000 will expire in two years (subject to vesting provisions) from the date of grant and 1,000,000 will expire after 1 year from the date of grant. The Options, and any underlying common shares issued on exercise thereof, will have a hold period expiring 4 months and one day, in accordance with the policies of the CSE and applicable securities laws. The Options are subject to the terms and conditions of the Company’s stock option plan and the policies of the CSE.

We seek Safe Harbor.
On behalf of the Board of Directors

“Rav Mlait”

CEO
Cannabix Technologies Inc.

For further information, contact the Company at info@cannabixtechnologies.com

The CSE has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.

[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




[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.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD
Phone: +41 79 407 72 58
Sileia Urech
Phone: +41 79 935 81 48
Nathalie Altermatt
Phone: +41 79 771 05 25
Lorena Corfas
Phone: +41 79 568 24 95
Simon Goldsborough
Phone: +44 797 32 72 915
Karsten Kleine
Phone: +41 79 461 86 83
Kirti Pandey
Phone: +49 172 636 72 62
Yvette Petillon
Phone: +41 79 961 92 50
Dr Rebekka Schnell
Phone: +41 79 205 27 03
 

Roche Investor Relations

Dr Bruno Eschli
Phone: +41 61 687 52 84
e-mail: bruno.eschli@roche.com
Dr Sabine Borngräber
Phone: +41 61 688 80 27
e-mail: sabine.borngraeber@roche.com 
Dr Birgit Masjost
Phone: +41 61 688 48 14
e-mail: birgit.masjost@roche.com
 

Investor Relations North America

Loren Kalm
Phone: +1 650 225 32 17
e-mail: kalm.loren@gene.com
 

Attachments

Cannabix Technologies announces Stock Option Grant

Cannabix Technologies announces Stock Option Grant




Cannabix Technologies announces Stock Option Grant

VANCOUVER, British Columbia, Oct. 22, 2025 (GLOBE NEWSWIRE) — Cannabix Technologies Inc. (CSE: BLO) (OTC PINK: BLOZF) (Frankfurt: 8CT) (the “Company or Cannabix”) reports it has granted 2,500,000 incentive stock options (“the Options”) to certain directors and consultants of the Company, exercisable at $0.55. 700,000 of the Options will expire in five years from the date of grant, 800,000 will expire in two years (subject to vesting provisions) from the date of grant and 1,000,000 will expire after 1 year from the date of grant. The Options, and any underlying common shares issued on exercise thereof, will have a hold period expiring 4 months and one day, in accordance with the policies of the CSE and applicable securities laws. The Options are subject to the terms and conditions of the Company’s stock option plan and the policies of the CSE.

We seek Safe Harbor.
On behalf of the Board of Directors

“Rav Mlait”

CEO
Cannabix Technologies Inc.

For further information, contact the Company at info@cannabixtechnologies.com

The CSE has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.

BrightCraft Dental Announces Comprehensive Sedation and Digital Full-Arch Transformation Model in Burbank

BrightCraft Dental Announces Comprehensive Sedation and Digital Full-Arch Transformation Model in Burbank




BrightCraft Dental Announces Comprehensive Sedation and Digital Full-Arch Transformation Model in Burbank

BURBANK, CA, Oct. 22, 2025 (GLOBE NEWSWIRE) —

BrightCraft Dental announced the launch of its new transformative care model centered on sedation (“sleep dentistry”), digital implant planning, and full-arch restorative solutions at its Burbank practice. This development reflects a new era of precision-driven, patient-centered care that merges advanced digital design with the art and science of life-changing smile transformations.

Dr. Tigran’s team!

Redefining Comprehensive, Comfort-Based Dentistry

The initiative highlights BrightCraft’s evolution from technology-driven dentistry to transformation-based care, focusing on patients’ comfort, confidence, and long-term health. The model emphasizes sedation dentistry for complex cases, allowing patients to comfortably undergo full-arch implant reconstructions, cosmetic porcelain restorations, and complete smile transformations, all performed while they sleep.

“Our mission is to help patients rediscover confidence through comfortable, transformative care,” said Dr. Tigran Gyokchyan, founder of BrightCraft Dental. “By combining advanced sedation techniques with digital precision and world-class craftsmanship, we’re able to deliver results that are not just functional, but truly life-changing.”

Integration of Digital Design and Predictable Outcomes

Under the new model, BrightCraft has incorporated computer-assisted design and manufacturing (CAD/CAM) technology, CEREC systems for same-day restorations, and advanced 3D imaging into every stage of treatment planning. These systems enable predictable, highly aesthetic outcomes, especially for full-arch restorative and implant cases that require precision and interdisciplinary coordination.

The digital workflow allows each treatment to be mapped virtually before clinical execution, ensuring both efficiency and consistency across restorative and cosmetic procedures.

A Holistic, Interdisciplinary Approach

BrightCraft’s updated structure integrates implantology, prosthodontics, orthodontics, cosmetic dentistry, and endodontics—all within one facility. This comprehensive, sedation-enabled environment allows complex cases to be completed seamlessly and comfortably under one roof.

From single-implant restorations to complete smile makeovers, BrightCraft’s approach reflects a new standard in modern dentistry: one that blends digital precision, artistry, and total patient relaxation.

Leadership and Vision

Dr. Tigran Gyokchyan, a graduate of the University of Southern California with postgraduate training at Harvard University and UCLA, leads the initiative. He holds Mastership distinctions from the Academy of General Dentistry and the International Congress of Oral Implantologists.

“Dentistry is about more than procedures, it’s about transformation, trust, and comfort,” Dr. Gyokchyan explained. “By focusing on sedation, digital design, and full-arch restorations, we’ve created a care experience that feels effortless for patients and yields predictable, lasting results.”

Commitment to Quality and Transparency

All systems and technologies used at BrightCraft are FDA-cleared and sourced from verified dental manufacturers. The practice maintains strict HIPAA compliance and adheres to evidence-based treatment protocols to ensure both safety and transparency in patient care.

About BrightCraft Dental

BrightCraft Dental is a leading restorative and cosmetic practice in Burbank, California, specializing in sedation (“sleep”) dentistry, full-arch implant transformations, and advanced digital workflows. Supported by an in-house dental lab and interdisciplinary team, BrightCraft combines artistry, technology, and compassion to deliver truly transformative smiles.

Discover the future of world-class dentistry at https://brightcraftcenter.com.

Media Contact
Company Name: BrightCraft Dental & Laser
Contact Person: Ms. Asasia
Email: asasia@empowerdentalgroup.com
Country: United States
Website: https://brightcraftcenter.com/

CONTACT: Media Contact
Company Name: BrightCraft Dental & Laser
Contact Person: Ms. Asasia
Email: asasia@empowerdentalgroup.com
Country: United States
Website: https://brightcraftcenter.com/

HUTCHMED Highlights HMPL-A251 Data Presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

HUTCHMED Highlights HMPL-A251 Data Presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics




HUTCHMED Highlights HMPL-A251 Data Presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

— First investigational drug candidate using the HUTCHMED ATTC technology platform to create potent targeted therapy payloads while mitigating related toxicities —

— Unique, highly potent PI3K/PIKK inhibitor payload optimized to exploit antibody-conjugate advantages, with directed delivery and low plasma exposure of free payload —

— Preclinical data shows robust antitumor activity with synergistic and bystander killing effects —

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Oct. 23, 2025 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces preclinical data for HMPL-A251 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, held October 22–26, 2025, in Boston, USA. HMPL-A251 is a first-in-class PI3K/AKT/mTOR (“PAM”)-HER2 Antibody-Targeted Therapy Conjugate (“ATTC”) comprising of a highly selective and potent PI3K/PIKK inhibitor payload linked to a humanized anti-HER2 IgG1 antibody, via a cleavable linker.

HER2 is a well-established therapeutic target. HER2 overexpression is found in a variety of cancer types and often associated with poor prognosis. As a key downstream signaling pathway of HER2, the PAM pathway contributes significantly to the resistance against HER2-targeting treatments when altered. HMPL-A251 is innovatively designed to leverage the synergy between HER2 targeting and PAM pathway inhibition to address limitations of traditional toxin-based antibody-drug conjugates (“ADCs”) and standalone PAM inhibitors.

In vitro, the PI3K/PIKK inhibitor payload exhibited high potency, selectivity, and broad anti-tumor activity across a panel of 130 tumor cell lines. By conjugating this potent payload with an anti-HER2 antibody via a hydrophilic linker, the ATTC compound HMPL-A251, upon binding to the HER2-positive target cells, undergoes rapid internalization, lysosomal trafficking, payload release, and inhibition of PAM and PIKK signaling, inducing tumor cell apoptosis. HMPL-A251 demonstrated HER2-dependent antitumor activity in vitro, potently inhibiting HER2-positive tumor cell growth regardless of PAM pathway alterations, with moderately reduced activity in HER2-low, PAM-altered cell lines. HMPL-A251 also demonstrated a bystander effect on HER2-null cells when co-cultured with HER2-positive cells.

Unlike toxin-based ADCs, which often face challenges with toxicity related to their cytotoxic payloads, ATTCs are designed to prioritize tumor-specific delivery of a pathway-modulating payload, enhancing safety for long-term use and enabling potential frontline combinations with chemotherapy. In vivo, HMPL-A251 demonstrated superior anti-tumor efficacy and tolerability as compared to the naked antibody and payload administered together. A single intravenous dose of HMPL-A251 induced tumor regression across multiple models including HER2-positive and HER2-low models with or without PAM alteration. Efficacy correlated strongly with payload concentration and target inhibition in tumor tissue. Notably, when benchmarked against T-DXd (trastuzumab deruxtecan, a HER2-directed ADC), HMPL-A251 achieved superior or comparable efficacy at equivalent doses in most tested models. Moreover, payload-based toxicities are expected to be low, as the plasma exposure of free payload was much lower than for HMPL-251, with a mass ratio of less than 1:500,000.

“We are excited to share the progress of HMPL-A251, the first candidate from our ATTC platform. It represents a potentially significant leap forward in addressing the limitations of toxin-based ADCs and narrow therapeutic window of systemic PAM inhibitors. By combining selective PI3K/PIKK inhibition with precise HER2 targeting, HMPL-A251 achieves potent antitumor effects while maintaining a favorable safety profile,” said Dr Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED. “The compelling preclinical data presented underscore its potential to redefine treatment for a wide spectrum of cancers, and we are excited to advance HMPL-A251 as well as more ATTC drug candidates toward clinical trials.”

HUTCHMED plans to initiate global clinical trials for HMPL-A251 around the end of 2025, followed by multiple global Investigational New Drug (IND) filings for more ATTC candidates in 2026.

About the ATTC platform

HUTCHMED’s Antibody-Targeted Therapy Conjugate platform represents a next-generation approach to precision oncology, combining monoclonal antibodies with proprietary small-molecule inhibitor payloads to deliver dual mechanisms of action. Unlike traditional cytotoxin-based ADCs, ATTCs combine targeted therapies to achieve synergistic anti-tumor activity and durable responses in preclinical models, outperforming standalone antibody or small-molecule inhibitor components in efficacy and safety.

Built on over 20 years of targeted therapy expertise, the platform enables development of drug candidates for diverse cancer types. By leveraging antibody-guided delivery and tumor-specific payload release, ATTCs improve the accessibility to tumors and reduce off-tumor toxicity. This overcomes challenges of traditional small-molecule inhibitors, ensures safer long-term use, and supports combinations with chemotherapy and immunotherapy, unlocking potential for early-line treatments.

About HUTCHMED

HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of HMPL-A251 and other drug candidates from the ATTC platform, the further clinical development for HMPL-A251 and other drug candidates from the ATTC platform, its expectations as to whether any studies on HMPL-A251 and other drug candidates from the ATTC platform would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of HMPL-A251 and other drug candidates from the ATTC platform, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of HMPL-A251 other drug candidates from the ATTC platform for a targeted indication, and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

CONTACTS

Investor Enquiries +852 2121 8200 / ir@hutch-med.com
   
Media Enquiries  
FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com
Ben Atwell / Alex Shaw +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
   
Panmure Liberum Nominated Advisor and Joint Broker
Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500
   
Cavendish Joint Broker
Geoff Nash / Nigel Birks +44 20 7220 0500
   
Deutsche Numis Joint Broker
Freddie Barnfield / Jeffrey Wong / Duncan Monteith +44 20 7260 1000

HUTCHMED Highlights HMPL-A251 Data Presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

HUTCHMED Highlights HMPL-A251 Data Presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics




HUTCHMED Highlights HMPL-A251 Data Presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

— First investigational drug candidate using the HUTCHMED ATTC technology platform to create potent targeted therapy payloads while mitigating related toxicities —

— Unique, highly potent PI3K/PIKK inhibitor payload optimized to exploit antibody-conjugate advantages, with directed delivery and low plasma exposure of free payload —

— Preclinical data shows robust antitumor activity with synergistic and bystander killing effects —

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Oct. 23, 2025 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces preclinical data for HMPL-A251 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, held October 22–26, 2025, in Boston, USA. HMPL-A251 is a first-in-class PI3K/AKT/mTOR (“PAM”)-HER2 Antibody-Targeted Therapy Conjugate (“ATTC”) comprising of a highly selective and potent PI3K/PIKK inhibitor payload linked to a humanized anti-HER2 IgG1 antibody, via a cleavable linker.

HER2 is a well-established therapeutic target. HER2 overexpression is found in a variety of cancer types and often associated with poor prognosis. As a key downstream signaling pathway of HER2, the PAM pathway contributes significantly to the resistance against HER2-targeting treatments when altered. HMPL-A251 is innovatively designed to leverage the synergy between HER2 targeting and PAM pathway inhibition to address limitations of traditional toxin-based antibody-drug conjugates (“ADCs”) and standalone PAM inhibitors.

In vitro, the PI3K/PIKK inhibitor payload exhibited high potency, selectivity, and broad anti-tumor activity across a panel of 130 tumor cell lines. By conjugating this potent payload with an anti-HER2 antibody via a hydrophilic linker, the ATTC compound HMPL-A251, upon binding to the HER2-positive target cells, undergoes rapid internalization, lysosomal trafficking, payload release, and inhibition of PAM and PIKK signaling, inducing tumor cell apoptosis. HMPL-A251 demonstrated HER2-dependent antitumor activity in vitro, potently inhibiting HER2-positive tumor cell growth regardless of PAM pathway alterations, with moderately reduced activity in HER2-low, PAM-altered cell lines. HMPL-A251 also demonstrated a bystander effect on HER2-null cells when co-cultured with HER2-positive cells.

Unlike toxin-based ADCs, which often face challenges with toxicity related to their cytotoxic payloads, ATTCs are designed to prioritize tumor-specific delivery of a pathway-modulating payload, enhancing safety for long-term use and enabling potential frontline combinations with chemotherapy. In vivo, HMPL-A251 demonstrated superior anti-tumor efficacy and tolerability as compared to the naked antibody and payload administered together. A single intravenous dose of HMPL-A251 induced tumor regression across multiple models including HER2-positive and HER2-low models with or without PAM alteration. Efficacy correlated strongly with payload concentration and target inhibition in tumor tissue. Notably, when benchmarked against T-DXd (trastuzumab deruxtecan, a HER2-directed ADC), HMPL-A251 achieved superior or comparable efficacy at equivalent doses in most tested models. Moreover, payload-based toxicities are expected to be low, as the plasma exposure of free payload was much lower than for HMPL-251, with a mass ratio of less than 1:500,000.

“We are excited to share the progress of HMPL-A251, the first candidate from our ATTC platform. It represents a potentially significant leap forward in addressing the limitations of toxin-based ADCs and narrow therapeutic window of systemic PAM inhibitors. By combining selective PI3K/PIKK inhibition with precise HER2 targeting, HMPL-A251 achieves potent antitumor effects while maintaining a favorable safety profile,” said Dr Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED. “The compelling preclinical data presented underscore its potential to redefine treatment for a wide spectrum of cancers, and we are excited to advance HMPL-A251 as well as more ATTC drug candidates toward clinical trials.”

HUTCHMED plans to initiate global clinical trials for HMPL-A251 around the end of 2025, followed by multiple global Investigational New Drug (IND) filings for more ATTC candidates in 2026.

About the ATTC platform

HUTCHMED’s Antibody-Targeted Therapy Conjugate platform represents a next-generation approach to precision oncology, combining monoclonal antibodies with proprietary small-molecule inhibitor payloads to deliver dual mechanisms of action. Unlike traditional cytotoxin-based ADCs, ATTCs combine targeted therapies to achieve synergistic anti-tumor activity and durable responses in preclinical models, outperforming standalone antibody or small-molecule inhibitor components in efficacy and safety.

Built on over 20 years of targeted therapy expertise, the platform enables development of drug candidates for diverse cancer types. By leveraging antibody-guided delivery and tumor-specific payload release, ATTCs improve the accessibility to tumors and reduce off-tumor toxicity. This overcomes challenges of traditional small-molecule inhibitors, ensures safer long-term use, and supports combinations with chemotherapy and immunotherapy, unlocking potential for early-line treatments.

About HUTCHMED

HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of HMPL-A251 and other drug candidates from the ATTC platform, the further clinical development for HMPL-A251 and other drug candidates from the ATTC platform, its expectations as to whether any studies on HMPL-A251 and other drug candidates from the ATTC platform would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of HMPL-A251 and other drug candidates from the ATTC platform, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of HMPL-A251 other drug candidates from the ATTC platform for a targeted indication, and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

CONTACTS

Investor Enquiries +852 2121 8200 / ir@hutch-med.com
   
Media Enquiries  
FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com
Ben Atwell / Alex Shaw +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
   
Panmure Liberum Nominated Advisor and Joint Broker
Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500
   
Cavendish Joint Broker
Geoff Nash / Nigel Birks +44 20 7220 0500
   
Deutsche Numis Joint Broker
Freddie Barnfield / Jeffrey Wong / Duncan Monteith +44 20 7260 1000

HearAdvisor Announces New Guide on the Best Hearing Aids and Earplugs of 2025 with Expert Choice Awards

HearAdvisor Announces New Guide on the Best Hearing Aids and Earplugs of 2025 with Expert Choice Awards




HearAdvisor Announces New Guide on the Best Hearing Aids and Earplugs of 2025 with Expert Choice Awards

Rockford, Il, Oct. 22, 2025 (GLOBE NEWSWIRE) — HearAdvisor, an independent audio performance lab, today announced the winners of its 2025 Expert Choice Awards, recognizing the best hearing aids and earplugs of the year. Now in its third year, the awards highlight products that deliver exceptional sound quality and performance based on rigorous objective lab testing. HearAdvisor is the only lab worldwide offering independent, data-driven comparisons for hearing aids and concert earplugs, with testing completed on more than 100 hearing aids and 30 earplugs.

HearAdvisor Announces Best Hearing Aids and Earplugs of 2025 with Expert Choice Awards

HearAdvisor is the only lab worldwide offering independent, data-driven comparisons for hearing aids and concert earplugs, with testing completed on more than 100 hearing aids and 30 earplugs.

New for 2025:

  • Blind Listening Test: Visitors can now compare the sound of 100+ hearing aids to learn which products make it easier for them to hear speech in noise.
  • Lab Notes: Product pages now include device setup and programming details.

Featured Winners

When the FDA finalized the over-the-counter (OTC) hearing aid category in 2022, the goal was better access to high-quality, affordable hearing technology. While lab-testing results for non-premium OTC products were modest at first, HearAdvisor’s 2025 tests reveal that some budget OTC devices are finally delivering on that goal.

With prices ranging from $599 to $1,299, these are some of this year’s standout OTC products: Elehear Beyond Pro, Lexie B2 Plus, Lucid Engage, Lucid Tala, and Yeasound RIC800. HearAdvisor also highlights hearing protection. For example, Etymotic Research ER20XS earned top marks for sound quality and reduction.

Quotes from HearAdvisor

“We’re seeing better and better performance in OTC hearing aids, even for those on a small budget.” – Dr. Abram Bailey, AuD, Co-Founder and Business Development

“Our mission is to make hearing technology more transparent and accessible through rigorous and objective lab testing.” – Dr. Andy Sabin, PhD, Scientific Advisor

“This is our third year testing, and we continue to be inspired by the feedback we receive from the community. It reassures and motivates us to keep going, whether through new Lab Notes on product pages or our new listening test.” – Dr. Steve Taddei, AuD, Co-Founder and Lab Director

Learn More

The full list of 2025 Expert Choice Award winners is available at HearAdvisor.com/awards.

About HearAdvisor

Founded in 2022, HearAdvisor provides objective, science-based evaluations of hearing technology. HearAdvisor aims to empower people to make more informed decisions about hearing health. Learn more at HearAdvisor.com.

HearAdvisor Announces Best Hearing Aids and Earplugs of 2025 with Expert Choice Awards

HearAdvisor Lab Director Dr Steve Taddei securely fitting Loop Earplugs on the acoustic test manikin.

Press inquiries

HearAdvisor
https://www.hearadvisor.com/
Dr Steve Taddei
steve@hearadvisor.com 

A video accompanying this announcement is available at https://www.youtube.com/embed/-wSoGyqL9r0

HearAdvisor Announces New Guide on the Best Hearing Aids and Earplugs of 2025 with Expert Choice Awards

HearAdvisor Announces New Guide on the Best Hearing Aids and Earplugs of 2025 with Expert Choice Awards




HearAdvisor Announces New Guide on the Best Hearing Aids and Earplugs of 2025 with Expert Choice Awards

Rockford, Il, Oct. 22, 2025 (GLOBE NEWSWIRE) — HearAdvisor, an independent audio performance lab, today announced the winners of its 2025 Expert Choice Awards, recognizing the best hearing aids and earplugs of the year. Now in its third year, the awards highlight products that deliver exceptional sound quality and performance based on rigorous objective lab testing. HearAdvisor is the only lab worldwide offering independent, data-driven comparisons for hearing aids and concert earplugs, with testing completed on more than 100 hearing aids and 30 earplugs.

HearAdvisor Announces Best Hearing Aids and Earplugs of 2025 with Expert Choice Awards

HearAdvisor is the only lab worldwide offering independent, data-driven comparisons for hearing aids and concert earplugs, with testing completed on more than 100 hearing aids and 30 earplugs.

New for 2025:

  • Blind Listening Test: Visitors can now compare the sound of 100+ hearing aids to learn which products make it easier for them to hear speech in noise.
  • Lab Notes: Product pages now include device setup and programming details.

Featured Winners

When the FDA finalized the over-the-counter (OTC) hearing aid category in 2022, the goal was better access to high-quality, affordable hearing technology. While lab-testing results for non-premium OTC products were modest at first, HearAdvisor’s 2025 tests reveal that some budget OTC devices are finally delivering on that goal.

With prices ranging from $599 to $1,299, these are some of this year’s standout OTC products: Elehear Beyond Pro, Lexie B2 Plus, Lucid Engage, Lucid Tala, and Yeasound RIC800. HearAdvisor also highlights hearing protection. For example, Etymotic Research ER20XS earned top marks for sound quality and reduction.

Quotes from HearAdvisor

“We’re seeing better and better performance in OTC hearing aids, even for those on a small budget.” – Dr. Abram Bailey, AuD, Co-Founder and Business Development

“Our mission is to make hearing technology more transparent and accessible through rigorous and objective lab testing.” – Dr. Andy Sabin, PhD, Scientific Advisor

“This is our third year testing, and we continue to be inspired by the feedback we receive from the community. It reassures and motivates us to keep going, whether through new Lab Notes on product pages or our new listening test.” – Dr. Steve Taddei, AuD, Co-Founder and Lab Director

Learn More

The full list of 2025 Expert Choice Award winners is available at HearAdvisor.com/awards.

About HearAdvisor

Founded in 2022, HearAdvisor provides objective, science-based evaluations of hearing technology. HearAdvisor aims to empower people to make more informed decisions about hearing health. Learn more at HearAdvisor.com.

HearAdvisor Announces Best Hearing Aids and Earplugs of 2025 with Expert Choice Awards

HearAdvisor Lab Director Dr Steve Taddei securely fitting Loop Earplugs on the acoustic test manikin.

Press inquiries

HearAdvisor
https://www.hearadvisor.com/
Dr Steve Taddei
steve@hearadvisor.com 

A video accompanying this announcement is available at https://www.youtube.com/embed/-wSoGyqL9r0