Roche Holding AG

Roche Holding AG is a research healthcare company. It operates through the Roche Pharmaceuticals and Diagnostics segments. The Roche Pharmaceutical division comprises the business segments, such as Roche Pharmaceuticals and Chuga. The Diagnostic division consists of the following four business areas: centralized and point of care solutions, molecular diagnostics, tissue diagnostics and diabetes care. The company was founded by Fritz Hoffmann-La Roche on October 1, 1896 and is headquartered in Basel, Switzerland.

Basel, 15 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the Phase III STARGLO study met its primary endpoint of overall survival. The study demonstrated that 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, lived longer when treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx. Safety of the combination appeared consistent with the known safety profiles of the individual medicines. The data will be submitted to health authorities and shared at an upcoming medical meeting.

[Ad hoc announcement pursuant to Art. 53 LR] Roche's Columvi meets primary endpoint of overall survival in people with relapsed or refractory diffuse large B-cell lymphoma in Phase III STARGLO study

A Roche-Lilly collaboration to test for indications of Alzheimer's disease won FDA Breakthrough Device Designation on Thursday. The new test will now proceed to clinical trials needed for full FDA approval.

Why Roche Holdings Stock Popped Today

Basel, 11 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This blood test, which is being developed in collaboration with Eli Lilly and Company, will be used to help identify the presence or absence of amyloid pathology in individuals, which can help ensure they are able to receive appropriate care. This may include participation in clinical trials or access to approved disease-modifying therapies. If approved, the test could help rapidly broaden access to a more timely and accurate diagnosis and potentially mitigate the impact of Alzheimer's disease on people and society.

Roche granted FDA Breakthrough Device Designation for blood test to support earlier Alzheimer's disease diagnosis

Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2.1 Patients with HER2-low status may now be eligible for HER2-targeted treatment, which could significantly improve their outcome.2 The VENTANA HER2 (4B5) test is the only approved companion diagnostic indicated as an aid in the assessment of HER2-low status in metastatic breast cancer patients. TUCSON, Ariz.

Roche obtains CE Mark for first companion diagnostic to identify patients with HER2-low metastatic breast cancer eligible for ENHERTU

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BURLINGTON, Mass.--(BUSINESS WIRE)-- #AI--Brian Roche has been appointed CEO at Veracode. His ascension from Chief Product Officer completes a succession plan, which sees Sam King step down.

Veracode Embarks on a New Chapter with Appointment of Brian Roche as Chief Executive Officer

Basel, 26 March 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the U.S. Food and Drug Administration (FDA) approval of the cobas® Malaria test for use on the cobas® 6800/8800 Systems. This approved test can aid healthcare professionals in reducing potential risks of patient infection from transfused blood products. The cobas Malaria test provides a highly sensitive and specific solution to help ensure that infected blood units are removed from the blood supply.

Roche receives FDA approval for the first molecular test to screen for malaria in blood donors

Eli Lilly

Regeneron Pharmaceuticals

Prescription weight loss drugs, like GLP-1 agonists and orlistat, offer effectiveness for some individuals and have proven effects the market has taken notice of. These drugs focus on curbing appetite, which investors in weight loss drug stocks have noticed.

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Novo Nordisk's Wegovy represents a significant advancement in obesity treatment, demonstrating a more profound weight-loss effect compared to its predecessor, Saxenda. Eli Lilly's entry with Zepbound, targeting both GLP-1 and GIP, signifies a competitive market landscape, potentially outperforming Wegovy in efficacy. The race to redefine obesity treatment is heating up, with several other pharmaceutical companies developing GLP-1 agonists and exploring alternative targets.

Shaping The Future Of Obesity Treatment: GLP-1 Agonists At The Forefront

Roche (RHHBY) is likely to enter the growing diabetes market with its AI-enabled predictive glucose monitoring system that may revolutionize diabetes management.

Roche (RHHBY) Launches AI-Based Predictive CGM Accu-Chek

Basel, 12 March 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its shareholders had approved all proposals of the Board of Directors at its Annual General Meeting. The 635 shareholders in attendance, who represented 77.02% of the total 106,691,000 shares, approved the Annual Financial Statements and Consolidated Financial Statements for 2023, the Remuneration Report and the Sustainability Report.

Roche Annual General Meeting 2024

Roche introduces its suite of navify operational excellence solutions, including navify Analytics and navify Monitoring, for use in laboratories and point of care services navify Analytics provides operational insights to lab managers and point of care coordinators to manage workflows more efficiently, reduce costs, and improve productivity Insights from navify Analytics, combined with the real-time insights from navify Monitoring, help laboratories operate more efficiently while maintaining quality and improving test turnaround times for labs ROTKREUZ, Switzerland, March 12, 2024 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) introduces navify Analytics, its suite of cloud-based solutions that provide actionable insights to optimise operational and financial outcomes in laboratories and point of care (POC) settings. navify Analytics for POC will make its debut at the HIMSS 2024 Conference in Orlando, USA, from 11-15 March 2024.

Roche showcases new navify® digital solutions that generate operational insights for faster decision-making in diagnostics at HIMSS¹ 2024

Alnylam Pharmaceuticals

Roche and partner Alnylam said on Tuesday their experimental drug against high blood pressure was shown to work when used in combination with the standard of care in a phase 2 trial.

Roche, Alnylam say blood pressure drug succeeds in mid-stage trial

Basel, 05 March 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Alnylam announced today that the Phase II KARDIA-2 study [ NCT05103332 ] of zilebesiran, an investigational RNAi therapeutic in development for the treatment of hypertension (high blood pressure) - the leading cause of cardiovascular disease worldwide1 - met its primary endpoint. People with mild to moderate hypertension treated with zilebesiran added to a standard of care hypertension medication experienced a clinically and statistically significant reduction in systolic blood pressure at month three. Zilebesiran added to a standard of care demonstrated an encouraging safety and tolerability profile.

Roche and Alnylam report positive topline results from the Phase II KARDIA-2 study in people with hypertension, demonstrating clinically significant blood pressure reductions with zilebesiran when added to standard of care

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Roche is considering selling its lung disease drug Esbriet, Bloomberg News reported on Monday citing people with knowledge of the matter.

Roche explores selling lung disease drug, Bloomberg reports

Roche's financial performance in 2023 showed growth despite the decline in COVID-related sales. The company achieved significant milestones, including US approval for Vabysmo, US review for Xolair, and EU approval for a subcutaneous form of Tecentriq. Roche faces challenges with its pipeline and acquisitions but remains confident in its future growth prospects.

Roche: Strong Long-Term Potential Overshadowed

Basel, 25 February 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today data from Stage 1 of the National Institutes of Health (NIH)-sponsored pivotal Phase III OUtMATCH study evaluating the efficacy and safety of Xolair® (omalizumab) in patients allergic to peanuts and at least two other common foods were published in the New England Journal of Medicine (NEJM) and featured in a late-breaking symposium at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The study showed treatment with Xolair increased the amount of peanuts, milk, egg, wheat and tree nuts (cashew, hazelnut and walnut) that it took to cause moderate to severe allergic reactions in multi-food allergic people as young as 1 year. Safety findings were consistent with the known safety profile of Xolair across its approved indications and in previous clinical trials.4 The U.S. Food and Drug Administration (FDA) recently approved the expanded use of Xolair in children and adults with IgE-mediated food allergies based on the OUtMATCH data.

New England Journal of Medicine publishes Phase III data showing Xolair significantly reduced allergic reactions across multiple foods in people with food allergies

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today data from Stage 1 of the National Institutes of Health (NIH)-sponsored pivotal Phase III OUtMATCH study evaluating the efficacy and safety of Xolair® (omalizumab) in patients allergic to peanuts and at least two other common foods were published in the New England Journal of Medicine (NEJM) and featured in a late-breaking symposium at the 2024 American Academy of Al.

New England Journal of Medicine Publishes Phase III Data Showing Xolair Significantly Reduced Allergic Reactions Across Multiple Foods in People With Food Allergies

Xolair, a 20-year-old asthma drug sold by Roche and Novartis , significantly reduced allergic reactions in people with multiple severe food allergies in a late-stage trial, researchers reported on Sunday at a medical meeting.

Roche's Xolair reduces reactions to severe food allergies in study

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Roche (RHHBY) obtains FDA approval for Xolair for the treatment of children and adults with one or more food allergies.

Roche's (RHHBY) Xolair Gets Approval for Food Allergies

Basel, 16 February 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and paediatric patients aged 1 year and older with IgE-mediated food allergy. People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as “food allergen avoidance”). Xolair should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. Immunoglobulin E (IgE)-mediated food allergies are the most common type and are typically characterised by the rapid onset of symptoms following exposure to certain food allergens.3 Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies. Xolair is widely available and can now be prescribed for appropriate patients with IgE-mediated food allergy in the U.S.

FDA approves Xolair as first and only medicine for children and adults with one or more food allergies

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. People taking Xolair for food allergies should continue to avoid all foods.

FDA Approves Xolair as First and Only Medicine for Children and Adults With One or More Food Allergies

PathAI will exclusively work with Roche Tissue Diagnostics (RTD) to develop artificial intelligence (AI) digital pathology algorithms for RTD's companion diagnostics business. The image analysis algorithms will be deployed on Roche's navify Digital Pathology platform, allowing seamless integration into pathology laboratories worldwide.

News for Roche Holding AG Stock (RHHBY)