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.

Roche (RHHBY) gets full approval for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan, cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients who have previously untreated DLBCL.

Roche (RHHBY) Polivy Combination for DLBCL Gets Full Approval

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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S.

FDA Approves Genentech's Polivy in Combination With R-CHP for People With Certain Types of Previously Untreated Diffuse Large B-cell Lymphoma

Basel, 19 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of two or greater. This FDA decision converts the accelerated approval of Polivy in combination with bendamustine and Rituxan for relapsed or refractory (R/R) DLBCL after at least two prior therapies to regular approval.

[Ad hoc announcement pursuant to Art. 53 LR] FDA approves Roche's Polivy in combination with R-CHP for people with certain types of previously untreated diffuse large B-cell lymphoma

Roche's (RHHBY) new data from the late-stage IMbrave050 study reveals that the combination of Tecentriq and Avastin reduces the risk of cancer relapsing in people with certain types of adjuvant liver cancer in a phase III study.

Roche (RHHBY) Announces Data on Tecentriq Combo for HCC

Roche Holding AG said Sunday that its tecentriq immunotherapy drug showed further positive results in an advanced study, demonstrating significant improvement in recurrence-free survival in patients.

Roche's Tecentriq shows further good survival rates as cancer treatment

Basel, 16 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new data from the Phase III IMbrave050 study that show Tecentriq® (atezolizumab) plus Avastin® (bevacizumab) demonstrated a statistically significant improvement in recurrence-free survival (RFS) in people with hepatocellular carcinoma (HCC) at high risk of disease recurrence following liver resection or ablation with curative intent.2

Roche's Tecentriq plus Avastin reduced the risk of cancer returning in people with certain types of adjuvant liver cancer in a Phase III study

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new data from the Phase III IMbrave050 study that show Tecentriq® (atezolizumab) plus Avastin® (bevacizumab) demonstrated a statistically significant improvement in recurrence-free survival (RFS) in people with hepatocellular carcinoma (HCC) at high risk of disease recurrence following liver resection or ablation with curative intent.

Genentech's Tecentriq Plus Avastin Reduced the Risk of Cancer Returning in People With Certain Types of Adjuvant Liver Cancer in a Phase III Study

Basel, 13 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data for its approved and investigational medicines will be highlighted in 30 abstracts at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, which will be held from 23-27 April 2023 in New Orleans, United States. The abstracts showcase the strength and breadth of Roche's Ophthalmology portfolio, including post-hoc data from phase III Vabysmo® (faricimab) studies that support its benefit in drying retinal fluid in neovascular or ‘wet' age-related macular degeneration (nAMD) and diabetic macular edema (DME).1 - 3 Real-world data on Vabysmo treatment patterns and outcomes will be presented, as well as approaches to personalised healthcare that include the use of artificial intelligence (AI) modelling to predict retinal disease progression.4-7 Additionally, phase I data for an investigational anti-interleukin-6 (IL-6) treatment in uveitic macular edema (UME), to be presented for the first time, suggest the monoclonal antibody may improve visual acuity in patients with UME.8

Roche data highlights strength of ophthalmology portfolio and commitment to advancing eye care at ARVO 2023

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new data for its approved and investigational medicines will be highlighted in 30 abstracts at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, which will be held from April 23-27 in New Orleans, LA.

Genentech Data Highlights Strength of Ophthalmology Portfolio and Commitment to Advancing Eye Care at ARVO 2023

ROTKREUZ, Switzerland , April 11, 2023 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) introduces its navify® Algorithm Suite, a single platform hosting a library of digital medical algorithms that generate patient-centric insights and can aid earlier diagnosis of cancer and other conditions per intended use, at the HIMSS Global Conference in Chicago, USA, from April 17- 21, 2023.

Roche introduces navify® Algorithm Suite, a digital library of medical algorithms that enhances clinical decision-making to optimise patient care

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The decline in sales of COVID-19 products hurt the company's 2022 bottom line. Many new treatments for cancers and other diseases are coming to market.

Roche's Slow Growth Shouldn't Drive Investors Away

Roche (RHHBY) and Lilly announce a collaboration deal to support the development of the former's early diagnosis device for Alzheimer's Disease.

Roche (RHHBY) & Lilly to Co-Develop Alzheimer's Detection Device

Eli Lilly

If approved, the test could streamline the diagnostic journey and help patients get earlier access to future Alzheimer's treatments, Roche said.

Alzheimer's Blood Test That Could Help Diagnose Disease Earlier Is Being Developed By Eli Lilly And Roche

Basel, 22 March, 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has entered into a collaboration with Eli Lilly and Company to support the development of Roche's Elecsys® Amyloid Plasma Panel (EAPP). The EAPP is an innovative blood test that aims to facilitate the earlier diagnosis of Alzheimer's disease.

Roche announces collaboration with Lilly to enhance early diagnosis of Alzheimer's disease

The company saw improved earnings in 2022 but predicts a small drop this year. Roche's stock is down 28% over the past year.

Is Roche a Buy Now?

Basel, 20th March 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new long-term data for Evrysdi® (risdiplam) in a broad range of people aged 2-25 years with spinal muscular atrophy (SMA) from the pivotal SUNFISH study1. Data confirm increases in motor function were sustained at four years and the overall rate of adverse events continued to decrease over the 48 month period, reinforcing the long-term efficacy and safety of Evrysdi. Participants also reported continuous improvement or stabilisation when independently performing activities of daily living such as eating, drinking and picking up and moving objects. The data were presented at the Muscular Dystrophy Association (MDA) Clinical and Scientific Conference, March 19-22, 2023. “Preserving long-term independence and the ability to perform daily tasks is an important measure for people living with SMA and their caregivers. It's encouraging to see that Evrysdi has meaningfully affected this aspect of their lives,” said Laurent Servais, M.D., Ph.D., Professor of Paediatric Neuromuscular Diseases at the MDUK Oxford Neuromuscular Centre. “This trial included people with Type 2 and 3 SMA, including patients with advanced disease. These latest data make us confident that the improvement observed during the first year of treatment is sustained during four years which contrasts with the decline we would observe in the absence of treatment.” The increase in motor function from baseline observed during the first year of the study was maintained through the fourth year of treatment with Evrysdi, as measured by changes in Motor Function Measure 32 (MFM-32) and Revised Upper Limb Module (RULM). Without treatment, natural history data show that patients with Type 2 or 3 SMA typically show a decline in motor function over time. Evrysdi was well-tolerated over the four-year time period. Adverse events (AEs) and serious adverse events (SAEs) were reflective of the underlying disease. The most commonly reported AEs include headache, fever (pyrexia) and upper respiratory tract infection. No treatment-related AEs led to withdrawal from the study. “These new data show that treatment with Evrysdi may help people with Type 2 or 3 SMA to maintain improvements in muscle strength and mobility over the course of several years,” said Levi Garraway, M.D., Ph. D., Chief Medical Officer and Head of Global Product Development. “The longer-term results of this study add to the robust body of findings from our broad clinical trial programme evaluating Evrysdi across a variety of ages, disease severities and treatment histories.” In addition to bringing Evrysdi to people around the world, Roche also leads its clinical development as part of a collaboration with the SMA Foundation and PTC Therapeutics. Roche is currently investigating Evrysdi in combination with an anti-myostatin molecule targeting muscle growth in the Ph II/III trial Manatee for the treatment of SMA. About Evrysdi ® ( risdiplam ) Evrysdi is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube. Evrysdi is designed to treat SMA by increasing and sustaining the production of SMN protein in the central nervous system (CNS) and peripheral tissues. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement. Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by the U.S. Food and Drug Administration in 2017. In 2021, Evrysdi was awarded Drug Discovery of the Year by the British Pharmacological Society as well as the Society for Medicines Research award for Drug Discovery. Evrysdi is currently approved in more than 90 countries and the dossier is under review in a further 16 countries. Evrysdi is currently being evaluated in five multicentre trials in people with SMA:

New four year data for Roche's Evrysdi reinforce long-term efficacy and safety profile in some of the most severely affected people with types 2 and 3 spinal muscular atrophy (SMA)

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new long-term data for Evrysdi® (risdiplam) in a broad range of people aged 2-25 years with spinal muscular atrophy (SMA) from the pivotal SUNFISH study. Data confirm increases in motor function were sustained at four years and the overall rate of adverse events continued to decrease over the 48-month period, reinforcing the long-term efficacy and safety of Evrysdi.

New Four-Year Data for Genentech's Evrysdi Reinforce Long-Term Efficacy and Safety Profile in Some of the Most Severely Affected People With Types 2 and 3 Spinal Muscular Atrophy (SMA)

Basel, 14 March 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the ordinary Annual General Meeting has elected Severin Schwan as the new Chairman of the Board of Directors with 98.32% of the votes and has approved all of the Board's proposals. The 574 shareholders present, who represented 75.94% of the total of 106,691,000 shares, approved the Management Report, the Financial Statements and the Consolidated Financial Statements for 2022, the Remuneration Report and the revision of the Articles of Incorporation.

Roche Annual General Meeting 2023

Roche (RHHBY) gets majority votes from the FDA's Advisory Committee for Polivy combination for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL).

Roche (RHHBY) Polivy Combo Backed by FDA Advisory Committee

A U.S. Food and Drug Administration committee voted in favor of Roche Holding AG's Polivy antibody drug targeting untreated diffuse large B-cell lymphoma, the most common form of non-Hodgkin lymphoma in the U.S.

FDA committee backs Roche's lymphoma treatment

Basel, 10 March 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 in favour of Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). The ODAC provides the FDA with independent opinions and recommendations from outside medical experts though the recommendations are not binding. The FDA is expected to make a final decision on its review of the supplemental Biologics License Application (sBLA) for Polivy in this indication by 2 April 2023. “Today's committee decision to recognise the potential of this Polivy combination as a first-line treatment option is important since four in ten people with diffuse large B-cell lymphoma relapse or do not respond to initial treatment,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We believe the clinical benefit demonstrated in the POLARIX study may improve outcomes for many people with newly diagnosed DLBCL and look forward to continued collaboration with the FDA to make this treatment option available in the US.”

FDA Advisory Committee votes in favour of the clinical benefit of Roche's Polivy combination for people with previously untreated diffuse large B-cell lymphoma

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) Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 in favor of Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL).

FDA Advisory Committee Votes in Favor of the Clinical Benefit of Genentech's Polivy Combination for People With Previously Untreated Diffuse Large B-Cell Lymphoma

Roche has logged a few clinical successes lately, but hasn't scored the sort of big wins that change investment theses or drive lasting changes in sentiment. Fourth quarter pharmaceutical sales were fine, and Roche has a strong roster of $1B-plus/year drugs, but growth may be limited to around 3% to 4% over time.

News for Roche Holding AG Stock (RHHBY)