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 is working with Nvidia to bring AI to its drug development subsidiary. It's also collaborating with a handful of biotech businesses for the same purpose.

This Big Pharma Is Teaming Up With Nvidia to Make Drugs With AI. Here's What You Need to Know

Basel, 19 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted, under Priority Review, the company's supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods in adult and paediatric patients aged 1 year and older with food allergy. If approved, people taking Xolair would still need to avoid foods they are allergic to (commonly referred to as “food avoidance”). The filing acceptance is based on positive interim analysis results from stage 1 of the National Institutes of Health (NIH)-sponsored pivotal phase III OUtMATCH study evaluating Xolair in patients allergic to peanuts and at least two other common foods. If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure. The FDA is expected to make a decision on approval in the first quarter of 2024.4

FDA grants priority review to Xolair (omalizumab) for children and adults with food allergies based on positive National Institutes of Health phase III study results

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 accepted, under Priority Review, the company's supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with food a.

FDA Grants Priority Review to Xolair (omalizumab) for Children and Adults With Food Allergies Based on Positive National Institutes of Health Phase III Study Results

Healthcare professionals greatly value navify Tumor Board for improving tumour board meeting experiences, offering a holistic view of data, facilitating multidisciplinary team collaboration and optimising care decisions navify POC Operations attains excellent ratings from health professionals for enhancing point-of-care device management to improve patient care navify Lab Operations' ability to consolidate and automate lab processes led to 100% of professionals indicating they would buy again ROTKREUZ, Switzerland , Dec. 19, 2023 /PRNewswire/ -- Roche announced today that healthcare professionals provided  three of Roche's navify digital solutions  with excellent ratings, in terms of performance and satisfaction, in an independent report by KLAS® Research, a leading healthcare IT insights company. The solutions included navify ® Tumor Board, navify ® POC Operations and navify ® Lab Operations.

Roche navify digital solutions get excellent ratings from healthcare professionals in KLAS Research reports

Roche named among top three most sustainable healthcare companies in the Dow Jones Sustainability Indices The ranking acknowledges Roche's commitment to sustainability as an integral part of its business strategy Roche performed particularly well in innovation management, access to healthcare, greenhouse gas emissions, water management, resource efficiency and circularity, labour practice indicators and human rights This marks the 15th consecutive year that Roche has maintained its leading ranking Basel, 15 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) has again been recognised as one of the most sustainable companies in the Pharmaceuticals index of the Dow Jones Sustainability Indices (DJSI). Roche ranked third, Chugai Pharmaceuticals, a member of the Roche Group, ranked second.

Roche named among top three most sustainable healthcare companies in the Dow Jones Sustainability Indices

Basel, 11 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data from its CD20xCD3 T-cell engaging bispecific antibody programme, including eight oral presentations, were presented at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition, 9-12 December 2023. Based on 32-month and 3-year follow-ups of two pivotal studies for fixed-duration treatments of Columvi® (glofitamab) and Lunsumio® (mosunetuzumab), respectively, data show that remissions were maintained in the majority of patients with heavily pre-treated lymphomas.1,2 Additionally, new early-phase data of novel Columvi or Lunsumio combination regimens support ongoing investigation in Phase III studies in earlier lines of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).3,4,5,6 “Updated data from pivotal studies of Columvi and Lunsumio continue to provide compelling evidence for how fixed-duration therapies can deliver sustained, long-term benefit for people with difficult-to-treat lymphomas,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “Our data at ASH also demonstrate progress in evaluating our bispecific antibodies in earlier stages of disease and additional types of lymphoma so more people can benefit from our therapies.” Longer follow-up data from pivotal studies of fixed-duration Columvi and Lunsumio show benefit is maintained beyond the end of treatment Extended follow-up data from the pivotal Phase II NP30179 study of Columvi administered for up to 12 cycles (approximately eight months) in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who have received at least two prior lines of therapy showed favourable long-term outcomes. After a median follow-up of 32 months, 55% of patients with a complete response (CR) were in remission at 24 months. Most of these patients remained progression-free and alive 18 months after completing the fixed-duration treatment. In patients who had received prior chimeric antigen receptor (CAR) T-cell therapy, the median duration of CR was 22.0 months (95% confidence interval [CI]: 6.7–not reached). No new safety signals were observed since the previous analysis.1 Data from a three-year follow-up analysis of the pivotal Phase II GO29781 study of Lunsumio in patients with R/R FL who have received at least two prior lines of therapy were presented. Results showed continued durable responses and a manageable safety profile after treatment (up to approximately 12 months), with 59% of patients completing treatment after eight cycles (approximately five months). 72.7% of the patients with a CR were alive and without disease progression, 30 months after their first response. In the overall population, median progression-free survival (PFS) was 24 months (95% CI: 12.0–not evaluable [NE]) and overall survival (OS) was not yet reached. No new safety signals were observed since the previous analysis.2 Additional data presented reinforce the potential of novel combination regimens in earlier treatment settings Diffuse large B-cell lymphoma Data from the Phase Ib/II GO40516 study of Lunsumio plus Polivy® (polatuzumab vedotin) in patients with R/R LBCL were presented and simultaneously published in Nature Medicine.3,7 Results showed that at 24 months median follow-up, the median PFS was 11.4 months (95% CI: 6.2–18.7), and median OS was 23.3 months (95% CI: 14.8–NE), highlighting the combination's potential in R/R LBCL. The overall safety profile of patients with R/R LBCL treated with Lunsumio plus Polivy was manageable. Cytokine release syndrome (CRS) events were generally low grade (Grade 1: 10.2%; Grade 2: 5.1%; Grade 3: 3.1%).3 Lunsumio in combination with Polivy is being evaluated as an outpatient therapy for patients with R/R DLBCL in the ongoing Phase III SUNMO study. Results from both arms of the Phase Ib NP40126 study evaluating Columvi in combination with MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), and Columvi in combination with Polivy plus MabThera/Rituxan, cyclophosphamide, doxorubicin and prednisone (Pola+R-CHP) in previously untreated DLBCL were presented. After a median of 12 months follow-up, data from the Columvi plus Pola+R-CHP arm showed that 91.7% of patients had a CR with no progression observed. Of the patients with a CR, 95.5% were still in remission, with a 12-month PFS rate of 91.5%. Safety profiles were highly consistent with earlier analyses from this study.4 These data support the ongoing Phase III SKYGLO study in previously untreated DLBCL. Follicular lymphoma The Phase II MorningSun study, evaluating a subcutaneous (SC) formulation of Lunsumio in patients with selected B-cell non-Hodgkin lymphomas, showed that SC Lunsumio is active and has a manageable safety profile in patients with first-line (1L) low-tumour burden FL. Data showed that 83.3% of patients achieved a complete metabolic response (95% CI: 62.6-95.3) and responses were ongoing at data cut-off. CRS was generally low grade (Grade 1: 36.7%; Grade 2: 6.7%) and occurred in cycle one only.5 Subcutaneous Lunsumio is also being investigated in combination with oral lenalidomide in 1L FL in the Phase Ib/II CO41942 study. New data demonstrated promising efficacy and manageable safety; data showed that 89.2% of patients achieved a CR and CRS events were either Grade 1 (47.5%) or 2 (2.5%), all of which were confined to cycles one to two.6 The data support further investigation of this SC formulation of Lunsumio and highlight its potential as a tailored monotherapy or combination outpatient therapy for FL, including in community practices.5,6 Totality of data presented underscores the strength of Roche's broad, industry-leading development programme, which aims to address the diverse needs, preferences and experiences of people with blood cancers Both Columvi and Lunsumio are being investigated in Phase III studies that will expand the understanding of their impact in earlier lines of treatment. This includes the Phase III STARGLO study evaluating Columvi in combination with GemOx in patients with R/R DLBCL who are ineligible for autologous stem cell transplant; the Phase III SKYGLO study evaluating the efficacy and safety of Columvi plus Pola+R-CHP in previously untreated DLBCL; the Phase III GLOBRYTE study evaluating Columvi monotherapy in R/R mantle cell lymphoma; the Phase III SUNMO study investigating Lunsumio plus Polivy in R/R DLBCL; and the Phase III CELESTIMO study investigating Lunsumio plus lenalidomide in patients with R/R FL. About Columvi® (glofitamab) Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T-cells, a type of immune cell, and two regions that bind to CD20, a protein on B-cells, which can be healthy or malignant. This dual-targeting brings the T-cell in close proximity to the B-cell, activating the release of cancer cell-killing proteins from the T-cell. A clinical development programme for Columvi is ongoing, investigating the molecule as a monotherapy and in combination with other medicines for the treatment of people with B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma and other blood cancers. About Lunsumio® (mosunetuzumab) Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. This dual-targeting activates and redirects a patient's existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. A robust clinical development programme for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, and other blood cancers. About Polivy® (polatuzumab vedotin) Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed in the majority of B-cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as those expressing CD79b and destroys these B-cells through the delivery of an anti-cancer agent, which is thought to minimise the effects on normal cells. Polivy is being developed by Roche using Seagen ADC technology and is currently being investigated for the treatment of several types of NHL. About Roche in haematology Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, Tecentriq® (atezolizumab), and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

New data for Roche's Columvi and Lunsumio presented at ASH 2023 support continued benefit for people with lymphoma

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new data from its CD20xCD3 T-cell engaging bispecific antibody program, including eight oral presentations, were presented at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition, December 9-12, 2023. Based on 32-month and 3-year follow-ups of two pivotal studies for fixed-duration treatments of Columvi® (glofitamab-gxbm) and Lunsumio®.

New Data for Genentech's Columvi and Lunsumio Presented at ASH 2023 Support Continued Benefit for People With Lymphoma

Basel, 09 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the primary analysis of the Phase III HAVEN 7 study reinforced the efficacy and safety of Hemlibra® (emicizumab) in previously untreated or minimally treated infants with severe haemophilia A without factor VIII inhibitors. Results showed that Hemlibra achieved meaningful bleed control in babies up to 12 months of age, and was well tolerated.1 The new data were presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition taking place 9-12 December 2023, in San Diego, California, and included in the press programme.

New data reinforce the benefit of early preventative treatment with Roche's Hemlibra for babies with severe haemophilia A

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the primary analysis of the Phase III HAVEN 7 study reinforced the efficacy and safety of Hemlibra® (emicizumab-kxwh) in previously untreated or minimally treated infants with severe hemophilia A without factor VIII inhibitors. Results showed that Hemlibra achieved meaningful bleed control in babies up to 12 months of age and was well tolerated. The new data we.

New Data Reinforce the Benefit of Early Preventative Treatment With Genentech's Hemlibra (emicizumab-kxwh) for Babies With Severe hemophilia A

Basel, 8 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive long-term follow-up data from the pivotal, phase III KATHERINE study in people with HER2-positive early-stage breast cancer (eBC) who have residual invasive disease following neoadjuvant (before surgery) treatment. A statistically significant and clinically meaningful improvement in overall survival (OS), a secondary endpoint, was observed with adjuvant (post-surgery) Kadcyla® (trastuzumab emtansine) compared to Herceptin® (trastuzumab): at the 7-year landmark OS rates were 89.07% and 84.37% with Kadcyla and Herceptin, respectively (hazard ratio [HR]=0.66, 95% CI: (0.51, 0.87), p-value =0.0027).2 Data also show that the previously reported invasive disease-free survival (primary endpoint) benefit is maintained.2 Kadcyla reduced the risk of disease recurrence or death from any cause by 46% compared to Herceptin (HR=0.54, 95% CI: (0.44, 0.66), p-value

Roche's Kadcyla is the first targeted therapy to show significant overall survival benefit in people with HER2-positive early-stage breast cancer with residual invasive disease after neoadjuvant treatment

Basel, 8 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) presented today positive results from the Phase III INAVO120 study evaluating inavolisib in combination with palbociclib (Ibrance®) and fulvestrant as a first-line treatment for people with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer.1

Roche's inavolisib combination reduces the risk of disease progression by 57% in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), presented today positive results from the Phase III INAVO120 study evaluating inavolisib in combination with palbociclib (Ibrance®) and fulvestrant as a first-line treatment for people with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The inavolisib combination reduced the risk of disease worsening.

Genentech's Inavolisib Combination Reduces the Risk of Disease Progression by 57% in People With Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive long-term follow-up data from the pivotal, Phase III KATHERINE study in people with HER2-positive early-stage breast cancer (eBC) who have residual invasive disease following neoadjuvant (before surgery) treatment. A statistically significant and clinically meaningful improvement in overall survival (OS), a secondary endpoint, was observed with adjuvant (po.

Genentech's Kadcyla Is the First Targeted Therapy to Show Significant Overall Survival Benefit in People With HER2-Positive Early-Stage Breast Cancer With Residual Invasive Disease After Neoadjuvant Treatment

Roche's (RHHBY) phase III study evaluating inavolisib in combination with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation achieves its primary goal.

Roche (RHHBY) Breast Cancer Drug Meets Primary Goal in Phase III

Basel, 5 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the Phase III INAVO120 study of the investigational therapy, inavolisib, in combination with palbociclib (Ibrance®) and fulvestrant as a potential first-line treatment option for people with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The study met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement compared to palbociclib and fulvestrant alone. Overall survival data were immature at this time, but a clear positive trend has been observed. Follow-up will continue to the next analysis.

Roche announces positive Phase III results for inavolisib combination in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase III INAVO120 study of the investigational therapy, inavolisib, in combination with palbociclib (Ibrance®) and fulvestrant as a potential first-line treatment option for people with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The study met its primary.

Genentech Announces Positive Phase III Results for Inavolisib Combination in People With Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation

Roche Holding AG is the latest drug maker trying to take advantage of the booming demand for weight-loss drugs.

Roche Buys Carmot Therapeutics to Compete in Booming Market for Weight-Loss Drugs

Roche said Carmot Therapeutics' research and development portfolio “has great potential to treat obesity, diabetes and potentially other diseases” both on its own and in combination with Roche's assets.

Roche Will Buy Obesity And Diabetes Drugmaker Carmot Therapeutics In $2.7 Billion Deal

Roche (RHHBY) aims to enter the promising and much-in-demand obesity drug market with the acquisition of Carmot Therapeutics, Inc. for $2.7 billion.

Roche (RHHBY) to Acquire Obesity Drug Maker Carmot for $2.7B

Roche is expanding its obesity drug pipeline with the acquisition of Carmot Therapeutics for up to US$3.1 billion. Per the agreement, Roche will pay US$2.7 billion upfront to acquire private biotechnology firm Carmot with additional milestone payments of up to US$400 million available.

Roche to acquire obesity drugmaker Carmot Therapeutics for up to US$3.1B

Roche said it will spend up to $3.1 billion to acquire Carmot Therapeutics, a biotech firm developing obesity drugs.

Roche Stock Rises On $3.1 Billion Deal For Obesity Drugmaker

Roche Holding AG Genussscheine (SWX: ROG) says it will acquire Carmot Therapeutics for $2.7 billion in cash. Its shares are up 3.0% at writing.

Roche is buying Carmot to enter anti-obesity market

Roche is to acquire anti obesity drug developer Carmot Therapeutics, becoming the latest pharma company to enter the global weight-loss drugs market.

Roche enters obesity market with Carmot takeover but drugs may not be available until 2030

Eli Lilly

Novo Nordisk

Roche has agreed to buy obesity-drug developer Carmot Therapeutics for up to $3.1 billion. The Swiss company is hoping to join Eli Lilly and Novo Nordisk at the forefront of the weight-loss drug market.

Roche Strikes $3.1 Billion Deal for Obesity Drugmaker. It Hopes to Compete with Eli Lilly, Novo Nordisk.

Roche has agreed to buy obesity-drug developer Carmot Therapeutics for up to $3.1 billion, as the world's top drugmakers rush to capitalize on the booming market for weight-loss drugs that has seen Novo Nordisk become Europe's most valuable company.

News for Roche Holding AG Stock (RHHBY)