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, 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.

Roche enters into collaboration agreement with PathAI to expand digital pathology capabilities for companion diagnostics

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Roche is a well-recognized pharmaceutical company with a strong international presence and a market capitalization of CHF 187 billion. Despite recent challenges, Roche's 2024 guidance shows potential for mid-single-digit growth in revenues and EPS, making it an interesting opportunity for long-term investors. We believe that the last few months decline could increase the interest of value investors as the stock is trading at historically low multiple valuation.

Roche: The Recent Sell-Off Created A 30% Upside Potential

Roche is cutting 345 jobs, Swiss website Muula reported, as the drugs company responds to lower profit posted for 2023 and a more cautious outlook for the year ahead.

Roche cutting 345 jobs in product development - media

Roche Holding AG (RHHBY) Q4 2023 Earnings Call Transcript

Roche (RHHBY) misses earnings and sales estimates in 2023 due to a significant decline in COVID-19-test sales. Currency rate fluctuations also impact results.

Roche (RHHBY) 2023 Earnings Miss, COVID-19 Product Sales Down

Roche said on Thursday that 2024 would see a return to sales growth as it is overcoming a slump in demand for its COVID-19 products and the sales decline of a trio of established cancer drugs is abating.

Roche forecasts return to growth in 2024 as it overcomes drop in COVID sales

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new 72-week data from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo® (faricimab-svoa) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO). Whereas available RVO treatments are typically given every one to two months, the data showed nearly 60% of people receiving Vabysmo in BALATON and up to 48% of people in COMIN.

New Long-Term Data for Genentech's Vabysmo Show Sustained Retinal Drying and Vision Improvements in Retinal Vein Occlusion (RVO)

Basel, 1 February 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new 72-week data from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo® (faricimab) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO).1,2 Whereas available RVO treatments are typically given every one to two months, the data showed nearly 60% of people receiving Vabysmo in BALATON and up to 48% of people in COMINO were able to extend their treatment intervals to three or four months apart.1,2,3,4 In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year. Retinal drying is an important clinical measure as swelling from excess fluid in the back of the eye has been associated with distorted and blurred vision.5 In both studies, Vabysmo was well tolerated and the safety profile was consistent with previous studies.

New long-term data for Roche's Vabysmo show sustained retinal drying and vision improvements in retinal vein occlusion (RVO)

Outlook for 2024 Roche expects an increase in Group sales in the mid single digit range (at constant exchange rates). Core earnings per share are targeted to develop broadly in line with sales growth (at constant exchange rates), excluding the impact from resolution of tax disputes in 2023. Roche expects to further increase its dividend in Swiss francs.

[Ad hoc announcement pursuant to Art. 53 LR] Roche exceeds guidance and achieves sales growth of 1% (CER) for 2023 despite sharp COVID-19 sales decline

BERKELEY, Calif., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Carmot Therapeutics Inc. (Carmot), a clinical-stage biotechnology company dedicated to developing life-changing therapeutics for people living with metabolic diseases including obesity and diabetes, today announced that its acquisition by the Roche Group (Roche) has been completed.

Carmot Therapeutics Announces Completion of Acquisition by Roche

Roche's (RHHBY) subcutaneous formulation of immuno-oncology drug Tecentriq receives EC's approval for all approved indications.

Roche's (RHHBY) Tecentriq Subcutaneous Gets Approval in the EU

Basel, 16 January 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted marketing authorisation for Tecentriq® SC (atezolizumab), the European Union (EU)'s first PD-(L)1 cancer immunotherapy for subcutaneous (under the skin) injection. Last year, more than 38,000 people in the EU received Tecentriq to treat different types of lung, liver, bladder and breast cancer.7 Until now, Tecentriq has been given directly into patients' veins by IV infusion which takes approximately 30-60 minutes.6 The new subcutaneous injection will cut treatment time to approximately seven minutes, with most injections taking between four and eight minutes.6 The marketing authorisation applies to all approved indications of Tecentriq IV.7

European Commission approves Roche's Tecentriq SC, the EU's first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types

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ASML dominates an incredibly valuable niche in the semiconductor supply chain. Pharmaceutical giant Roche sports an impressive product pipeline and attractive valuation.

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CNBC's Jim Cramer pointed out the numerous mergers and acquisitions across the biopharma industry.

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--MOMA Therapeutics, a biotechnology company focused on identifying and targeting highly dynamic, difficult to drug targets in cancer and other diseases, is pleased to announce a strategic collaboration and licensing agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY). This partnership provides Roche with access to MOMA's proprietary KnowledgeBase platform for the identification and prosecution of a certain number of novel drug targets involved in promoting cancer.

MOMA Therapeutics Announces Five-Year Discovery Collaboration with Roche Focused on Critical Cancer Dependencies

Remix to leverage REMaster™ platform to discover novel drugs for a diverse range of target classes Remix will receive $30 million upfront and is eligible to receive up to $12 million in near-term milestone payments and up to $1 billion in milestone payments and royalties WATERTOWN, Mass. , Jan. 3, 2024 /PRNewswire/ -- Remix Therapeutics (Remix), a clinical stage biotechnology company developing small molecule therapies to modulate RNA processing and address underlying drivers of disease, today announced a collaboration and license agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) for the discovery and development of small molecule therapeutics that modulate RNA processing using Remix's REMaster drug discovery platform.

News for Roche Holding AG Stock (RHHBY)