Basel, 23 May 2025 - 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 Itovebi™ (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. If approved, the Itovebi-based regimen has the potential to transform the standard of care in this first-line setting, where treatments are currently limited.¹ A final decision regarding the approval is expected from the European Commission in the near future.

Basel, 23 May 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today a strategic collaboration with Broad Clinical Labs to develop and pilot groundbreaking applications using Roche’s recently unveiled next-generation sequencing (NGS) Sequencing By Expansion (SBX) technology. This collaboration will focus on harnessing the power of the SBX technology to transform clinical genomics and biomedical discovery. It will also aim to establish the SBX technology as a routine offering for fast, scalable sequencing for Broad Clinical Lab’s research community.

Basel, 23 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today two-year follow-up data from the phase III STARGLO study. After a median follow-up of 24.7 months, data showed a 40% improvement in overall survival (OS) for patients treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) and OS was not reached, compared to 13.5 months for MabThera®/Rituxan® (rituximab) plus GemOx (R-GemOx).¹ These updated data continue to demonstrate the statistically significant and clinically meaningful survival benefit of this off-the-shelf, fixed-duration Columvi combination for people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant (ASCT).¹ Data will be presented in an oral session at the 61st American Society of Clinical Oncology (ASCO), 30 May – 3 June 2025.

Basel, 22 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the US and more than 100 million people globally.^1,2 It is the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with just one refill every nine months.^3,4 Susvimo is now available to US retina specialists and their patients with DR who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.

Basel, 20 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that a US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) discussed the supplemental Biologics License Application (sBLA) for Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant (ASCT).

Basel, 13 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit and Frontier Science Foundation, announced today statistically significant final overall survival (OS) results from the phase III APHINITY study in people with human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer.¹ After ten years, the risk of death was reduced by 17% for people treated with Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for a year as post-surgery (adjuvant) treatment, compared with individuals who received Herceptin, chemotherapy, and placebo.¹

Basel, 06 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of its Elecsys® PRO-C3 test, a new diagnostic solution designed to assess the severity of liver fibrosis in patients showing signs of metabolic dysfunction–associated steatotic liver disease (MASLD). The test, developed in partnership with Nordic Bioscience, offers clinicians a simple and efficient method of identifying patients with liver fibrosis of varying severity, enabling timely intervention and appropriate management of the disease.

Basel, 30 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an update to the European Union (EU) label for Phesgo®, a subcutaneous (SC) fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab), for human epidermal growth factor receptor 2 (HER2)-positive breast cancer. If approved, administration of Phesgo outside of a clinical setting (such as in a person’s home) by a healthcare professional will be possible, once safely established in a clinical setting. A final decision regarding the approval is expected from the European Commission in the near future.

Basel, 25 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the New England Journal of Medicine (NEJM) has published a detailed analysis of the phase III CENTERSTONE trial of Xofluza® (baloxavir marboxil).¹ The trial met its primary endpoint, showing a single, oral dose of Xofluza taken by people infected with influenza reduced the odds of untreated household members contracting the virus by 32%.¹ For the key secondary endpoint of influenza virus transmission resulting in symptoms, Xofluza showed a clinically meaningful reduction although statistical significance was not reached. Xofluza was well tolerated, with no new safety signals identified.¹

Basel, 23 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the introduction of its innovative Chest Pain Triage algorithm as part of the navifyⓇ Algorithm Suite. This groundbreaking algorithm is designed to more quickly and accurately detect Acute Coronary Syndrome (ACS) in patients presenting with chest pain, one of the most common reasons for Emergency Department (ED) visits. As EDs are typically one of the most crowded hospital units, leading to challenges to swiftly diagnose critical conditions, such as chest pain.⁴ This new algorithm was developed in collaboration with Universitätsklinikum Heidelberg.

Basel, 22 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will invest USD 50 billion into the United States of America in the next five years. These investments further strengthen Roche’s already significant US footprint with 13 manufacturing and 15 R&D sites across the Pharmaceutical and Diagnostics Divisions, and are expected to create more than 12,000 new jobs, including nearly 6,500 construction jobs,  as well as 1,000 jobs at new and expanded facilities.

Basel, 14 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant (ASCT). With this approval, this Columvi combination is the first bispecific antibody regimen available for people with DLBCL in Europe whose cancer has returned or for those who did not respond to initial treatment. In July 2023, Columvi received a conditional marketing authorisation to treat people with R/R DLBCL after two or more lines of systemic therapy. In addition to today’s approval, a condition to convert the existing marketing authorisation to a regular approval has been fulfilled.

Basel, 02 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Phase III MUSETTE trial comparing a high dose of OCREVUS® (ocrelizumab) intravenous (IV) infusion to the currently approved OCREVUS IV 600 mg dose in people with relapsing multiple sclerosis (RMS) did not meet its primary endpoint in showing additional benefit in slowing disability progression, as measured by a composite disability endpoint over a period of at least 120 weeks of treatment. The rates of disability progression were low and consistent with rates observed in the previous pivotal studies of OCREVUS IV 600 mg. In addition, in several predefined analyses on disease activity, OCREVUS IV 600 mg showed clinically meaningful results with the lowest annualised relapse rate (ARR) observed during the double-blind period of a Phase III study in RMS. The MUSETTE data further support the efficacy and safety profile of the currently approved OCREVUS IV 600 mg dose for RMS.

Basel, 17 March 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will present new data at the Muscular Dystrophy Association (MDA) conference, 16-19 March, 2025, in Dallas, Texas, from its neuromuscular portfolio, including 12 oral and poster presentations. These data demonstrate the breadth of Roche’s neuromuscular portfolio across spinal muscular atrophy (SMA) and Duchenne muscular dystrophy (DMD).

Basel, 12 March 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has entered into an exclusive collaboration and licensing agreement with Zealand Pharma (Nasdaq Copenhagen: ZEAL) (CVR-no. 20045078). Under the terms of this agreement, the two companies will collaborate to co-develop and co-commercialise petrelintide, Zealand Pharma’s amylin analog as a standalone therapy as well as a fixed-dose combination with Roche’s lead incretin asset CT-388.

Basel, March 7, 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY), announced today the launch of the Roche Genentech Innovation Center Boston at Harvard’s Enterprise Research Campus in Allston which will further strengthen the long-standing partnership in areas such as disease biology, engineering, and artificial intelligence / machine learning.

Basel, 5 March 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of lupus nephritis. The filing acceptance is based on positive results from the phase III REGENCY study, which showed improved complete renal response (CRR) with Gazyva/Gazyvaro plus standard therapy compared with standard therapy alone.¹ The FDA is expected to make a decision on approval by October 2025.

Basel, 2 March 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new positive data from Stage 2 and Stage 3 of the National Institutes of Health (NIH)-sponsored phase III OUtMATCH study, which provide further evidence supporting the role of Xolair® (omalizumab) for the treatment of one or more food allergies. Stage 2 of the OUtMATCH study showed Xolair was more effective with fewer side effects than multi-allergen oral immunotherapy (OIT) in the first-ever head-to-head trial comparing the two treatment approaches. OIT involves ingesting the food allergen, initially with a very small amount and gradually increasing the amount.  These findings were largely driven by the high rates of adverse events (AEs) leading to study discontinuation in the OIT-treated group.

Basel, 28 February 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant (ASCT). The standard second-line (2L) therapy for R/R DLBCL patients has historically been high-dose chemotherapy followed by stem cell transplant. New therapies have been recently introduced, however, not all patients can access or are eligible for these treatments.³ If approved, this Columvi combination could provide a much-needed, off-the-shelf treatment option. A final decision is expected from the European Commission in the near future.

Basel, 20 February 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) unveiled today its proprietary, breakthrough sequencing by expansion (SBX) technology, establishing a new category of next-generation sequencing. SBX chemistry, combined with an innovative sensor module, offers ultra-rapid, high-throughput sequencing that is both flexible and scalable for a broad range of applications.