Basel, 19 September - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline results of the phase III CENTERSTONE study of Xofluza® (baloxavir marboxil), an antiviral, showing a reduction in the transmission of influenza viruses. The study met its primary endpoint, demonstrating that a single, oral dose of Xofluza taken by people infected with influenza significantly reduced the likelihood of others in their household contracting the virus. Xofluza was well tolerated with no new safety signals identified.

Basel, 16 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the United States Food and Drug Administration (U.S. FDA) has approved OCREVUS ZUNOVO™ (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). OCREVUS ZUNOVO is the first and only twice-a-year, healthcare professional (HCP)-administered approximately 10-minute subcutaneous (SC) injection approved for both these forms of multiple sclerosis, giving people living with MS more treatment options.

Basel, 13 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq Hybreza^TM (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC), under the skin injection for patients in the United States. Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard intravenous (IV) infusion of Tecentriq (atezolizumab).² It will be available for all IV indications of Tecentriq approved for adults in the U.S., including certain types of lung, liver, skin and soft tissue cancer.³

Basel, 10 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the opening of its new Pharma Research and Early Development (pRED) Center at its global headquarters in Basel, Switzerland. Equipped with cutting-edge technologies and housing around 1,000 state-of-the-art laboratory and office workplaces, the new center brings together teams of scientists and researchers to accelerate scientific discoveries for patients.

Basel, 04 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new 48-week data for the investigational Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib from the Phase II FENopta open-label extension (OLE) study at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark on 18 September 2024. Results demonstrate that patients with relapsing multiple sclerosis (RMS) treated with fenebrutinib for up to one year maintained very low levels of disease activity and no disability progression.

Basel, 27 August 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved PiaSky® (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5, for adults and adolescents (12 years of age or older with a weight of 40 kg and above) with paroxysmal nocturnal haemoglobinuria (PNH) who are either new to, or have been previously treated with C5 inhibitors. PNH is a rare and life-threatening blood condition where red blood cells are destroyed by the complement system – part of the innate immune system – causing symptoms such as anaemia, fatigue and blood clots, and potentially leading to kidney disease.⁴

Basel, 30 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has approved Vabysmo® (faricimab) for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO, branch RVO or central RVO). RVO is the third indication for Vabysmo in the European Union, in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).¹ Together, the three retinal conditions affect close to 80 million people worldwide and are among the leading causes of vision loss.^2-5

Basel, 29 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the completion of the acquisition of LumiraDx’s Point of Care technology, following the receipt of all required antitrust and regulatory clearances. Roche will now embark on the full integration of the company’s innovative multi-assay point of care platform and the related R&D, operational and commercial sites into its global organisation.

Roche CEO Thomas Schinecker: “Our strong sales growth in the first half of 2024 reflects the high demand for our innovative medicines and diagnostics. In the second quarter, we saw an acceleration of our growth momentum as Group sales were no longer impacted by the decline in COVID-19 sales, resulting in very strong sales growth for the Group. Based on our strong half-year results, we are raising our earnings outlook for the full year.

Basel, 18 July 2024 Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today two-year data from the Phase III Pagoda and Pavilion studies evaluating Susvimo® (Port Delivery System with ranibizumab) for the treatment of diabetic macular edema (DME) and diabetic retinopathy (DR), respectively, the two leading causes of vision loss in adults with diabetes.^1-4 Susvimo is the first and only refillable eye implant that provides continuous delivery of a customised formulation of ranibizumab via the Port Delivery Platform.⁵ The results build on the primary one-year analyses of the Pagoda and Pavilion studies, with Susvimo demonstrating sustained efficacy over two years and safety consistent with the known safety profile for Susvimo in people with DME and DR.^6-9 Detailed results were presented at the American Society of Retina Specialists (ASRS) 2024 Annual Meeting in Stockholm, Sweden.

Basel, 17 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline results from two arms of an ongoing multi-part Phase I clinical trial for CT-996, an investigational, once-daily, oral small molecule GLP-1 receptor agonist being developed for the treatment of both type 2 diabetes and obesity.¹ The data showed that treatment with CT-996 in participants with obesity and without type 2 diabetes resulted in a clinically meaningful placebo-adjusted mean weight loss of -6.1% within four weeks (p <0.001).¹ The full study data will be presented at an upcoming medical meeting.

Basel, 09 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received the CE Mark for its Accu-Chek SmartGuide® continuous glucose monitoring (CGM) solution. This significant milestone paves the way for the solution to be made available to people living with type 1 and type 2 diabetes over the age of 18 on flexible insulin therapy.

Basel, 05 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the United States Food and Drug Administration (US FDA) has approved the Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect close to 80 million people globally.^1-4 The Vabysmo PFS will become available to United States (US) retina specialists and their patients in the coming months.

Basel, 04 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the phase II/III SKYSCRAPER-06 study, evaluating tiragolumab plus Tecentriq^® (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an initial (first-line) treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer, did not meet its primary endpoints of progression-free survival (PFS) at its primary analysis with a hazard ratio (HR) of 1.27 [95% CI: 1.02,1.57] and overall survival (OS) at its first interim analysis with a HR of 1.33 [95% CI: 1.02, 1.73], which was immature. The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy in both PFS and OS compared to the comparator arm in the intent-to-treat population, which includes the phase II and phase III cohorts. The overall safety profile remains consistent with the safety profile previously observed for the combination of tiragolumab plus Tecentriq and chemotherapy, and no new or unexpected findings were identified. Based on these results, patients and investigators will be unblinded and we intend to halt the study. A communication will be sent to the investigators and results will be shared with health authorities and subsequently presented at an upcoming medical meeting.

Basel, 28 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the Vabysmo® (faricimab) marketing authorisation to include the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO). A final decision regarding the approval is expected from the European Commission in the near future.

Basel, 28 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for PiaSky® (crovalimab) for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). The CHMP has recommended PiaSky, a novel recycling monoclonal antibody that inhibits the complement protein C5, for use in adults and adolescents (12 years of age or older with a weight of 40 kg) who are either new to, or have been previously treated with C5 inhibitors. If approved, PiaSky will be the first monthly subcutaneous (SC) treatment for PNH in the European Union, with the option to self-administer following adequate training. This may provide an alternative option to current C5 inhibitors that require regular intravenous (IV) infusions, potentially helping to reduce treatment burden and disruption to the lives of people with PNH and their caregivers.¹ A final decision regarding the approval of PiaSky is expected from the European Commission in the near future.

Basel, 27 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the World Health Organization (WHO) has awarded the cobas® HPV test prequalification designations for use on the cobas® 5800 system and for self-collected samples on the cobas® 5800, 6800 and 8800 systems. These new prequalification designations come just one month after the U.S. Food and Drug Administration approved Roche’s HPV self-collection solution and less than a year after the WHO awarded prequalification to the cobas HPV test on the cobas 6800/8800 systems.

Basel, 25 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted marketing authorisation for OCREVUS® (ocrelizumab) subcutaneous (SC) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). OCREVUS SC is a 10-minute injection that maintains the same twice-yearly schedule as the previously approved intravenous (IV) infusion. More than 350,000 people with multiple sclerosis have been treated with OCREVUS IV globally.

Basel, 24 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of its new analytical units, cobas® c 703 and cobas® ISE neo, for the cobas® pro integrated solutions, in countries accepting the CE mark. The cobas pro integrated solutions is a scalable and modular diagnostic platform designed for high-volume laboratories. The cobas c 703 and cobas ISE neo analytical units offer cutting-edge features to help address some of the key challenges faced by diagnostic laboratories worldwide such as shortage of qualified staff and space limitations.

Basel, 20 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the first clinically approved, highly-sensitive in-situ hybridisation (ISH) test, the VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, in countries accepting the CE Mark. The test is designed to help pathologists differentiate a B-cell malignancy from a normal, reactive response to an infection.⁴