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Roche Holding AG

Pipeline8 assets

  • fenebrutinibBTK / Small molecule / Neuroscience
    Multiple Sclerosis
  • petrelintideAmylin / Peptide / Cardiovascular, Renal & Metabolism
    Obesity
  • CT-996CT-996 / GLP-1 / Small molecule / Cardiovascular, Renal & Metabolism
    Obesity
  • giredestrantEstrogen receptor (SERD) / Small molecule / Oncology
    Early and metastatic breast cancer
  • trontinemabAmyloid beta / TfR / Bispecific antibody / Neuroscience
    Alzheimer's Disease
  • NXT007NXT007 / Factor IX/X / Bispecific antibody / Hematology
    Hemophilia A
  • afimkibartBiologic / Immunology
    Immunological disorders
  • RVT-3101RVT-3101 / TL1A / Monoclonal antibody / Immunology
    Inflammatory Bowel Disease

Latest news25 items

All news

Roche presents new data at EURETINA, highlighting Vabysmo’s real-world effectiveness and safety across major retinal conditions

New real-world results for Vabysmo in nAMD, DME and RVO reinforce robust effectiveness and durability across previously untreated and treated eyes, with no new safety signals 1-3 Advanced AI-enabled analysis of imaging confirms rapid and meaningful anatomical drying supporting Vabysmo as a standard-of-care therapy in routine clinical care 4,5 With more than...

Presentation / AbstractEURETINA 2026 presentations Thu, Oct 1, 2026

Roche’s giredestrant combination significantly improved progression-free survival in ER-positive advanced breast cancer in phase III evERA data published in The New England Journal of Medicine

Giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in ITT and ESR1 -mutated populations, respectively, versus standard endocrine therapy plus everolimus 1 By targeting resistance to endocrine treatments, the giredestrant combination seeks to delay disease progression and improve overall patient outcomes 1 The FDA...

Trial Results • Phase 3NEJM publication of evERA phase III results Thu, Oct 1, 2026

Roche’s fenebrutinib is the first BTK inhibitor to receive U.S. FDA filing acceptance in both relapsing and primary progressive multiple sclerosis

Fenebrutinib cut relapses by 51% and 58% vs teriflunomide in Phase III RMS trials (FENhance 1 & 2) while showing a consistent, positive trend in delaying disability 1 Fenebrutinib became the first investigational medicine in more than a decade to slow disability progression in a Phase III PPMS trial (FENtrepid), with numerical benefit vs Ocrevus 2...

Positive interim data shows Roche’s sefaxersen significantly reduces proteinuria in people with IgA nephropathy (IgAN)

In the phase III IMAgINATION study, sefaxersen demonstrated statistically significant and clinically meaningful reductions in proteinuria versus placebo at 37 weeks, showing best-in-class potential Sefaxersen inhibits complement factor B production at its primary source in the liver, thus blocking a key driver of IgAN-related kidney damage 1 IgAN is a...

Trial Results • Phase 3

Change in Roche’s Board of Directors

Roche announced today that the Board of Directors of Roche Holding Ltd has approved to propose Dr. Christophe Weber, former CEO of Takeda Pharmaceuticals, for election to the Board of Directors at Roche’s Annual General Meeting on March 9, 2027. Roche Chairman Severin Schwan:...

[Ad hoc announcement pursuant to Art. 53 LR] Roche announces positive Phase II results for dual GLP-1/GIP receptor agonist enicepatide in people living with type 2 diabetes and overweight or obesity

At the highest dose (24 mg), enicepatide achieved a mean HbA1c reduction of 2.65% at 48 weeks, highlighting its potential for best-in-disease glycemic control In patients with poor baseline glycemic control (HbA1c >8.5%), enicepatide 24 mg led to an HbA1c reduction of 4.13% at 48 weeks By week 48, 90% of patients in the 24 mg enicepatide arm met the T2D...

Trial Results • Phase 2Topline results Tue, Sep 22, 2026

Roche announces grand opening of its Innovation Center Boston to drive advancements in Cardiovascular, Renal and Metabolic diseases

The center will be a hub for Roche and Genentech, bringing together expertise in Cardiovascular, Renal and Metabolism, as well as for data science and AI specialists to drive innovation in drug discovery and development It will expand Roche’s and Genentech’s presence in Boston, reflecting a long-term commitment to one of the world’s leading life sciences...

Roche’s Lunsumio-based regimen significantly improves progression-free survival in follicular lymphoma in phase III CELESTIMO study

Phase III CELESTIMO study met its primary endpoint at the interim analysis demonstrating a statistically significant and clinically meaningful reduction in the risk of disease progression in people with follicular lymphoma who have received at least one prior line of treatment Data reinforce the potential of this Lunsumio-based regimen to improve clinical...

Trial Results • Phase 3

Roche’s collaborator MediLink announces phase III data for Tam-Peli showing significantly improved overall survival in Chinese patient population with relapsed small-cell lung cancer

Tambotatug pelitecan (Tam-Peli) demonstrated statistically significant efficacy over topotecan in a phase III study conducted in China, reducing the risk of death by 54% and disease progression by 71%, while achieving an objective response rate of 59.1% vs 9.7% 1 The novel B7-H3-targeted antibody-drug conjugate with a dual release mechanism of the payload...

Trial Results • Phase 3Phase III trial results Sun, Sep 13, 2026

Roche’s Vabysmo demonstrates sustained two-year results in a difficult-to-treat form of neovascular age-related macular degeneration (nAMD)

The SALWEEN study showed significant improvements in vision and retinal health 1 More than 60% of Asian patients with polypoidal choroidal vasculopathy (PCV), an aggressive subtype of nAMD, treated with Vabysmo showed no signs of polypoidal lesions 1,2 By the end of year two, more than 60% of patients were on an extended 20-week treatment interval, reducing...

Presentation / Abstract • Phase 4APVRS presentation Fri, Aug 28, 2026

CHMP recommends EU approval of Roche’s Susvimo, the first continuous delivery treatment for neovascular age-related macular degeneration (nAMD)

Susvimo is the first and only continuous delivery treatment that offers an alternative to standard of care eye injections for nAMD Positive recommendation is based on data from the LADDER, Archway and Portal studies showing Susvimo maintained vision equivalent to monthly intravitreal ranibizumab injections 1-3 By continuously delivering medicine into the...

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s strong momentum continues in the first half of 2026, delivering +6% sales growth at constant exchange rates; -2% in CHF due to the significant appreciation of the Swiss franc

Group sales were +6% at constant exchange rates (CER) 1 , -2% when reported in CHF and +8% in USD 2 , in the first six months, driven by high demand for innovative medicines and diagnostics. Pharmaceuticals Division sales were +6% at CER, -1% when reported in CHF and +8% in USD, due to continued high growth in sales of our medicines across disease areas;...

Roche receives CE Mark for blood test to identify tuberculosis infection

The Elecsys IGRA TB test expands global access to tuberculosis infection testing, advancing progress toward the World Health Organization's elimination targets. Performed on Roche’s industry-leading and widely available cobas immunoassay systems, the test enables laboratories to meet growing tuberculosis infection testing needs by reducing reliance on...

Roche presents new data in Alzheimer’s disease from across its integrated pharmaceutical and diagnostics portfolio at AAIC

Five oral presentations in a Featured Research Session will highlight trontinemab, including new long-term data from Phase Ib/IIa Brainshuttle TM AD study and design of Phase III PrevenTRON study in preclinical Alzheimer’s New data on Roche’s CE mark Elecsys pTau217 blood test will be presented on its use for Alzheimer's diagnosis in both primary and...

Presentation / Abstract • Phase 1/2AAIC oral presentation Tue, Jul 14, 2026, 2:00 PM BST

FDA grants Priority Review to Roche’s Enspryng, the first and only at-home subcutaneous treatment option for thyroid eye disease (TED)

The filing application is based on improvements seen across key efficacy endpoints from the global phase III SatraGO-1 and SatraGO-2 studies, including proptosis (bulging eyes) and diplopia (double vision) in active TED Enspryng (satralizumab) has the potential to become the first at-home subcutaneous disease-modifying standard of care for TED TED is an...

FDA accepts supplemental Biologics License Application for Roche’s Lunsumio and Polivy combination for people with relapsed or refractory large B-cell lymphoma

Filing acceptance based on data from the phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death 1 People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies If approved, this...

Roche Holding AG • Endpoint Arena