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, 23 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Lunsumio® (mosunetuzumab-axgb) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Lunsumio, a CD20xCD3 T-cell engaging bispecific antibody, represents a new class of fixed-duration cancer immunotherapy, which is off-the-shelf and readily available, so that patients do not have to wait to start treatment. Lunsumio will be available in the United States in the coming weeks. “This approval is a significant milestone for people with relapsed or refractory follicular lymphoma, who have had limited treatment options until now,” said Elizabeth Budde, M.D., Ph.D., Haematologic Oncologist and Associate Professor, City of Hope Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, and Lunsumio clinical trial investigator. “As a first-in-class T-cell engaging bispecific antibody that can be initiated in an outpatient setting, Lunsumio's high response rates and fixed-duration could change the way advanced follicular lymphoma is treated.” “Despite treatment advances, follicular lymphoma remains incurable and relapse is common, with outcomes worsening following each consecutive treatment,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “Lunsumio represents our first approved T-cell engaging bispecific antibody and builds on our legacy of more than 20 years of innovation in blood cancer.” The FDA approval is based on positive results from the phase II GO29781 study of Lunsumio in people with heavily pre-treated FL, including those who were at high risk of disease progression or whose disease was refractory to prior therapies. Results from the study showed high and durable response rates. An objective response was seen in 80% (72/90 [95% confidence interval (CI): 70-88]) of patients treated with Lunsumio, with a majority maintaining responses for at least 18 months (57% [95% CI: 44-70]). The objective response rate is the combination of complete response (CR) rate (a disappearance of all signs and symptoms of cancer) and partial response rate (a decrease in the amount of cancer in the body). The median duration of response among those who responded was almost two years (22.8 months [95% CI: 10-not reached]). A CR was achieved in 60% of patients (54/90 [95% CI: 49-70]). Among 218 patients with haematologic malignancies who received Lunsumio at the recommended dose, the most common adverse event (AE) was cytokine release syndrome (CRS; 39%), which can be severe and life-threatening. The median duration of CRS events was three days (range: 1-29). Other common AEs (≥20%) included fatigue, rash, pyrexia and headache. Lunsumio is administered as an intravenous infusion for a fixed-duration, which allows for time off therapy, and can be infused in an outpatient setting. Hospitalisation may be needed to manage select AEs, should be considered for subsequent infusions following a Grade 2 CRS event, and is recommended for subsequent infusions following a Grade 3 CRS event. Lunsumio was developed based on the Roche Group's broad expertise in creating bispecific antibodies. Lunsumio is designed to address the diverse needs of people with blood cancer, physicians, and practice settings, and is part of the company's robust bispecific antibody clinical programme in lymphoma. Lunsumio is being further investigated as a subcutaneous formulation (i.e., administered under the skin) and in phase III studies that will expand the understanding of its impact in earlier lines of treatment in people with non-Hodgkin lymphoma. About the GO29781 study The GO29781 study [ NCT02500407 ] is a phase II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of Lunsumio® (mosunetuzumab-axgb) in people with relapsed or refractory B-cell non-Hodgkin lymphoma. Outcome measures include complete response rate (best response) by independent review facility (primary endpoint), objective response rate, duration of response, progression-free survival, safety, and tolerability (secondary endpoints). About follicular lymphoma Follicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases.1 It typically responds well to treatment but is often characterised by periods of remission and relapse. The disease typically becomes harder to treat each time a patient relapses, and early progression can be associated with poor long-term prognosis. It is estimated that, in the United States, approximately 13,000 new cases of FL will be diagnosed in 2022 and more than 100,000 people are diagnosed with FL each year worldwide.1,2 About Lunsumio ® ( mosunetuzumab-axgb ) Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B-cells and CD3 on the surface of T-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 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) and Lunsumio® (mosunetuzumab-axgb). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab, targeting both CD20 and CD3, and cevostamab, targeting both FcRH5 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1 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. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

FDA approves Roche's Lunsumio, a first-in-class bispecific antibody, to treat people with relapsed or refractory follicular lymphoma

Following the FDA's approval, Roche (RHHBY) Lunsumio is the first CD20xCD3 T-cell engaging bispecific antibody approved to treat follicular lymphoma.

Roche's (RHHBY) Lunsumio Gets FDA Nod for Follicular Lymphoma

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Lunsumio® (mosunetuzumab-axgb) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Lunsumio, a CD20xCD3 T-cell engaging bispecific antibody, represents a new class of fixed-duration cancer immunotherapy, which is off-the-shelf and readily available, so that patients do not have to wait to start treatment. Lunsumio will be available in the United States in the coming weeks.

FDA Approves Genentech's Lunsumio, a First-in-Class Bispecific Antibody, to Treat People With Relapsed or Refractory Follicular Lymphoma

Roche (RHHBY) obtains FDA approval for Actemra (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adult patients. The drug was earlier granted an EUA.

Roche (RHHBY) Actemra Gets FDA Nod for Adults With COVID-19

Roche Holding AG ROG, -0.50% said late Wednesday that the Food and Drug Administration formally approved its monoclonal antibody for adults who have been hospitalized with severe COVID-19. Actemra received an emergency authorization in mid-2021 as a treatment for those 12 years old and older, and more than 1 million people have received treatment with the therapy, which is delivered to patients as one intravenous infusion that takes an hour.

Roche gets full FDA approval for COVID-19 treatment

Basel, 21 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Actemra® (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalised adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 and is recommended for use as a single 60-minute IV infusion.

FDA approves Roche's Actemra for the treatment of COVID-19 in hospitalised adults

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Actemra® (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 and is recommended for use as a single 60-minute IV infusion.

FDA Approves Genentech's Actemra for the Treatment of COVID-19 in Hospitalized Adults

Roche (RHHBY) receives a positive CHMP recommendation for label expansion of the hemophilia A drug Hemlibra in the European Union (EU).

Roche's (RHHBY) Hemophilia A Drug Gets Positive CHMP Opinion

Basel, 16 December 2022 - Roche (SIX: RO, ROG; OTCQZ: RHHBY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended expansion of the Hemlibra® (emicizumab) European Union (EU) marketing authorisation. If approved, Hemlibra would also be indicated for the routine prophylaxis of bleeding episodes in people with haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, who have moderate disease (FVIII ≥1% and ≤ 5%) with a severe bleeding phenotype. It is estimated that people with moderate haemophilia A make up 14% of the haemophilia A population.3

CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A

The potential for a tripledemic exists, as influenza, COVID-19 and RSV cases rise. Two out of three Americans are confused by the differences between PCR and rapid antigen tests in detecting viruses and when to use them.

New Survey Shows Many Americans Are Confused by Testing Options for COVID-19 and Flu

Basel, 14 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has entered into a U.S. focused collaboration with Pfizer to drive awareness and educate on the importance of timely COVID-19 testing, available treatment options, symptoms and the high-risk factors that can increase the chance of progressing to severe illness.

Roche announces U.S. collaboration with Pfizer to help patients who test positive for COVID-19 navigate risks, symptoms, testing and treatment options

Basel, 12 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that updated clinical data for its CD20xCD3 T-cell engaging bispecific antibodies, including five oral presentations, were presented at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition, 10-13 December 2022. Updated results for investigational bispecific glofitamab in people with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) suggest glofitamab has the potential to be the first, off-the-shelf CD20xCD3 T-cell engaging bispecific antibody that can be given for a fixed period of time to people with heavily pre-treated aggressive lymphoma.1 These data will be presented at the meeting, and simultaneously published online in the New England Journal of Medicine (NEJM).2 Additionally, updated data for Lunsumio® (mosunetuzumab) continued to demonstrate clinically meaningful outcomes in people with heavily pre-treated follicular lymphoma (FL).3 Lunsumio is a fixed-duration treatment that can be administered in the outpatient setting, which could allow people the possibility of experiencing a lasting remission with a treatment-free period.3

Roche presents new data demonstrating the potential benefit of glofitamab and Lunsumio as fixed-duration, off-the-shelf treatment options for lymphoma

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that updated clinical data for its CD20xCD3 T-cell engaging bispecific antibodies, including five oral presentations, were presented at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition, December 10-13, 2022. Updated results for the investigational bispecific glofitamab in people with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) suggest glofitamab has the potential to be the first off-the-shelf CD20xCD3 T-cell engaging bispecific antibody that can be given for a fixed period of time to people with heavily pretreated aggressive lymphoma. These data will be presented at the meeting and simultaneously published online in the New England Journal of Medicine (NEJM). Additionally, updated data for mosunetuzumab continued to demonstrate clinically meaningful outcomes in people with heavily pretreated follicular lymphoma (FL). Mosunetuzumab is a fixed-duration treatment that can be administered in the outpatient setting, which could allow people the possibility of experiencing a lasting remission with a treatment-free period.

Genentech Presents New Data Demonstrating the Potential of Glofitamab and Mosunetuzumab as Fixed-Duration, Off-The-Shelf Treatment Options for Lymphoma

Roche Holding AG presented new data from a Phase 3 study showing that its Polivy antibody-drug can significantly reduce the risk of disease deterioration or death for people with untreated diffuse large B-cell lymphoma.

Roche's phase 3 data show Lymphoma treatment can reduce disease risks

Roche has appointed Thomas Schinecker as the new group chief executive, the company said on Monday, replacing Severin Schwan who the pharmaceuticals giant has nominated to be its next chairman.

Roche names new CEO with Schwan set to become chairman

Basel, 12 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new and updated data for its first-in-class anti-CD79b antibody-drug conjugate Polivy® (polatuzumab vedotin) were presented at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition, 10-13 December. Data from the POLARIX study support the potential benefit of Polivy in combination with MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to improve outcomes for people with previously untreated diffuse large B-cell lymphoma (DLBCL).1

Roche presents new and updated data for Polivy in previously untreated diffuse large B-cell lymphoma at ASH 2022

[Ad hoc announcement pursuant to Art. 53 LR] Roche: Changes in the Board of Directors and the Corporate Executive Committee

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new and updated data for its first-in-class anti-CD79b antibody-drug conjugate Polivy® (polatuzumab vedotin-piiq) were presented at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition, December 10-13. Data from the POLARIX study support the potential benefit of Polivy in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to improve outcomes for people with previously untreated diffuse large B-cell lymphoma (DLBCL).

Genentech Presents New and Updated Data for Polivy in Previously Untreated Diffuse Large B-Cell Lymphoma at ASH 2022

Basel, 11 December 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced interim results from the phase III HAVEN 7 study. The study shows Hemlibra® (emicizumab) achieved meaningful bleed control with a favourable safety profile in infants (up to 12 months) with severe haemophilia A, without factor VIII inhibitors: 77.8% of participants did not have any bleeds that required treatment and 42.6% did not have any treated or untreated bleeds at all.1 These results help support the use of Hemlibra in this population, in which it is already approved in many countries around the world. The new data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans from 10-13 December 2022.

Interim data from phase III study presented at ASH 2022 show Hemlibra achieved meaningful bleed control in infants from birth

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced interim results from the Phase III HAVEN 7 study. The study shows Hemlibra® (emicizumab-kxwh) achieved meaningful bleed control with a favorable safety profile in infants (up to 12 months) with severe hemophilia A without factor VIII inhibitors: 77.8% of participants did not have any bleeds that required treatment and 42.6% did not have any treated or untreated bleeds at all. These results help support the use of Hemlibra in this population, in which it is already approved in many countries around the world. The new data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans from December 10-13, 2022.

Interim Data From Phase III Study Presented at ASH 2022 Show Hemlibra (emicizumab-kxwh) Achieved Meaningful Bleed Control in Infants From Birth

Basel, 11 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive new data from the phase III COMMODORE 3 study in China, demonstrating that crovalimab, a novel anti-C5 recycling monoclonal antibody, is efficacious and well-tolerated in people with paroxysmal nocturnal haemoglobinuria (PNH). The study met its co-primary efficacy endpoints of transfusion avoidance (TA) and haemolysis control, demonstrating that participants with PNH, who have not been treated previously with complement inhibitors and who received subcutaneous crovalimab injections every four weeks, achieved disease control.1 The data were presented at the American Society of Hematology (ASH) congress, taking place from 10-13 December 2022.

Roche's subcutaneous crovalimab given every four weeks achieves disease control in people with PNH, a life-threatening blood condition

Looking at the longer term, Roche stock is up 27% from levels seen in late 2018, compared to around 65% returns for the S&P500 index.

What's Driving Roche Stock?

The Ferrero Group, the Italian confectionery group, said it has agreed to buy Wells Enterprises, the world's largest family owned and managed ice cream company, for an undisclosed sum. Iowa-based Wells, whose brands include the Blue Bunny ice cream and the low-calorie Halo Top range, was founded in 1913 and produces more than 200 million gallons of ice cream per year.

Ferrero Roche owner agrees to buy Blue Bunny ice cream maker Wells Enterprises

Basel, 8 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its Elecsys® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys® Phospho-Tau (181P) CSF (pTau181) assays have received U.S. Food and Drug Administration (FDA) 510(k) clearance. The Elecsys AD CSF Abeta42 and pTau181 assays (used as a pTau181/Abeta42 ratio) measure two biomarkers that are hallmarks of Alzheimer's pathology, beta-amyloid and tau proteins, in adults ages 55 and older being evaluated for the disease.

Roche Alzheimer's disease Cerebrospinal Fluid (CSF) assays receive FDA clearance, supporting more accurate and timely diagnosis

INDIANAPOLIS , Dec. 5, 2022 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the appointment of Brad Moore as president and CEO of Roche Diagnostics North America, effective January 1, 2023. Moore currently serves as senior vice president, Core Lab and Point of Care, within Roche Diagnostics North America.

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