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.

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from its Phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq® (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC). The study did not meet its co-primary endpoint of progression-free

Genentech Reports Interim Results for Phase III SKYSCRAPER-01 Study in PD-L1-High Metastatic Non-Small Cell Lung Cancer

Basel, 11 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from its phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq® (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC). The study did not meet its co-primary endpoint of progression-free survival. At this first analysis, the other co-primary endpoint of overall survival (OS) was immature, and the study will continue until the next planned analysis. A numerical improvement was observed in both co-primary endpoints. Data suggest that tiragolumab plus Tecentriq was well-tolerated and no new safety signals were identified when adding tiragolumab. Further analyses of these results are ongoing and data will be presented at an upcoming medical meeting.

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports interim results for phase III SKYSCRAPER-01 study in PD-L1-high metastatic non-small cell lung cancer

Basel, 10 May 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has extended its commitment to the World Federation of Hemophilia (WFH) Humanitarian Aid Program until the end of 2028. Roche's prophylactic treatment will be provided to the WFH Humanitarian Aid Program to continue to treat as many as 1,000 people with haemophilia A in locations where there is little to no access to treatment. The partnership, which was originally formed by Roche and the WFH in February 2019, marked the first time that patients in developing countries had received access to a prophylactic treatment. The donated treatment has since benefited more than 940 people across 30 countries.

Roche pledges to extend commitment to the World Federation of Hemophilia Humanitarian Aid Program to 2028

Basel, 29 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new three-year data from the FIREFISH study, including one-year data from the open label extension, reinforcing the long-term efficacy and safety of Evrysdi® (risdiplam) in infants with symptomatic Type 1 spinal muscular atrophy (SMA). The data showed an estimated 91% of infants (n=58) treated with Evrysdi were alive after three years of treatment. The Evrysdi-treated infants continued to improve or maintain motor functions, including the ability to swallow, sit without support, stand with support and walk while holding on, between two and three years of treatment. Without treatment, children with Type 1 SMA are never able to sit without support. The study also showed overall continued reductions in serious adverse events (SAEs) and hospitalisations over time.

New three-year data for Roche's Evrysdi (risdiplam) show long-term improvements in survival and motor milestones in babies with Type 1 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 three-year data from the FIREFISH study, including one-year data from the open label extension, reinforcing the long-term efficacy and safety of Evrysdi® (risdiplam) in infants with symptomatic Type 1 spinal muscular atrophy (SMA). The data showed an estimated 91% of infants (n=58) treated with Evrysdi were alive after three years of treatment. The Evrysdi-treat

New Three-Year Data for Genentech's Evrysdi (risdiplam) Show Long-Term Improvements in Survival and Motor Milestones in Babies With Type 1 Spinal Muscular Atrophy (SMA)

Roche (RHHBY) performance in the first quarter was encouraging, driven by demand for COVID-19 tests and contribution from newer drugs.

Roche's (RHHBY) Q1 Sales Grow on COVID-19 Tests, New Drugs

Roche Holding AG ROG, -2.41% said Monday that a Phase 2 clinical study evaluating giredestrant as a treatment for patients with advanced breast cancer did not meet its primary endpoint of progression-free survival. The company told investors it is still testing giredestrant as a treatment for first-line metastatic breast cancer and early breast cancer.

Roche said experimental breast-cancer therapy didn't meet main endpoint in a Phase 2 study

Swiss drugmaker Roche's first quarter sales rose 10%, driven by drugs including Ocrevus against multiple sclerosis as well as Hemlibra against haemophilia, and on strong U.S. demand for rapid COVID-19 antigen tests.

Roche Q1 sales up 10%, confirms 2022 outlook

Group sales increase 11%1 at constant exchange rates (CER) and 10% in Swiss francs

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good sales growth in the first quarter of 2022

Basel, 22 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) as an adjuvant treatment, following complete resection and platinum-based chemotherapy, for adults with non-small cell lung cancer (NSCLC) with a high risk of recurrence whose tumours express PD-L1≥50% and who do not have EGFR mutant or ALK-positive NSCLC. A final decision regarding the approval of Tecentriq in this setting is expected from the European Commission in the near future. “The goal of treating early-stage cancers is to provide the best chance for a cure,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “Today's announcement brings hope that, after a decade of limited treatment advances, many people in Europe with early non-small cell lung cancer will soon have a new treatment option to reduce the risk of their disease returning.” “For approximately half of all people diagnosed with early-stage lung cancer, their disease will return at some point after surgery, and in some cases they will then be living with incurable metastatic cancer,” said Anne-Marie Baird, President of Lung Cancer Europe (LuCE). “Given what we are now seeing in the early-stage space, it is vital that biomarker testing is not only confined to Stage IV disease. Testing for biomarkers at diagnosis will help to identify people who may benefit from new adjuvant treatments to help reduce disease recurrence.” The recommendation from the CHMP is based on results from the DFS interim analysis of the Phase III IMpower010 study. The results showed treatment with Tecentriq, following complete resection and platinum-based chemotherapy, reduced the risk of disease recurrence or death (DFS) by 57% (unstratified hazard ratio [HR]=0.43, 95% CI:0.26-0.71) in people with Stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumours express PD-L1≥50% and who do not have EGFR mutant or ALK-positive NSCLC, compared with best supportive care (BSC).8 A DFS benefit was consistently seen across most subgroups including histology or stage of disease with adjuvant Tecentriq, compared with BSC. Overall survival (OS) data for patients with PD-L1 high resectable Stage II-IIIA NSCLC, and who do not have EGFR mutant or ALK-positive disease are immature and were not formally tested at the DFS interim analysis, however, a trend towards OS improvement with Tecentriq was seen, with a HR of 0.36 (95% CI: 0.17-0.75). Follow-up will continue with planned analyses of more mature OS data later this year. Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified.8 If approved, Tecentriq will be the first cancer immunotherapy available in Europe as an adjuvant treatment, following complete resection and platinum-based chemotherapy, for adults with a high risk of recurrence whose tumours express PD-L1≥50% and who do not have EGFR mutant or ALK-positive NSCLC. To date, Tecentriq has been approved in 14 countries, including the US and China, as an adjuvant treatment, following complete resection and chemotherapy, for adults with Stage II-IIIA (UICC/AJCC 7th edition) NSCLC whose tumours express PD-L1≥1%. In three countries, including Canada and the UK, Tecentriq has been approved as adjuvant treatment following complete resection and chemotherapy for adult patients with Stage II to IIIA (UICC/AJCC 7th edition) NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells. Tecentriq has shown clinically meaningful benefit in various types of lung cancer, with six currently approved indications in countries around the world. It was the first approved cancer immunotherapy for the first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks. Roche has an extensive development programme for Tecentriq including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumour types.

CHMP recommends EU approval of Roche's Tecentriq as adjuvant treatment for a subset of people with early-stage non-small cell lung cancer

Basel, 22 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval under conditional marketing authorisation for mosunetuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), who have received at least two prior systemic therapies. Based on this positive CHMP opinion, a final decision regarding the conditional approval of mosunetuzumab is expected from the European Commission in the near future. Follicular lymphoma is the second most common form of lymphoma globally, accounting for 20% of all non-Hodgkin lymphomas (NHL) diagnosed worldwide.[1] “The majority of people with follicular lymphoma experience frequent relapses, and with each successive therapy the duration of remission and survival shortens,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “Today's decision acknowledges the potential of mosunetuzumab as an efficacious, readily available, fixed-duration option, and brings the possibility of new hope to people living with this disease.” More than 28,000 people in Europe are diagnosed with FL each year.[1,2] The majority of people with FL relapse within five years after initial treatment, and for those who have received two or more prior therapies, conventional treatment options are currently limited and are associated with low rates of complete and durable remissions.[3,4] If approved, mosunetuzumab will be a first-in-class CD20xCD3 T-cell engaging bispecific antibody in NHL. The CHMP recommendation is based on positive results from the phase I/II GO29781 study where mosunetuzumab showed high complete response (CR) rates, with the majority of complete responders maintaining responses for at least 18 months, and favourable tolerability in people with heavily pretreated FL. After a median follow-up of 18.3 months, the CR rate was 60% (n=54/90), the objective response rate was 80% (n=72/90), and median progression-free survival was 17.9 months (95% CI: 10.1-not estimable). The median duration of response among those who responded was 22.8 months (95% CI: 9.7-not estimable). The most common adverse event was cytokine release syndrome (44.4%) which was generally low grade (grade 1: 25.6%; grade 2: 16.7%), and resolved by end of treatment. Treatment was administered without mandatory hospitalisation. Results were presented for the first time in December 2021 at the 63rd American Society of Hematology Annual Meeting & Exposition. [5] In June 2020, mosunetuzumab was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for the treatment of adult patients with FL who have received at least two prior systemic therapies. A robust development programme for mosunetuzumab is ongoing including two phase III studies: CELESTIMO investigating mosunetuzumab plus lenalidomide in second line plus (2L+) FL, and SUNMO, investigating mosunetuzumab plus Polivy® (polatuzumab vedotin) in 2L+ diffuse large B-cell lymphoma (DLBCL). This recommendation is Roche's second CHMP positive opinion in NHL in 2022, following the positive opinion for Polivy in combination with MabThera® (rituximab) plus cyclophosphamide, doxorubicin and prednisone in previously untreated DLBCL.[6] With our broad portfolio and pipeline, we are committed to providing treatment solutions for different stages of blood disorders, that are tailored to the disease, patient, physician, and healthcare system, as monotherapies or in combination with established and/or novel agents. About mosunetuzumab Mosunetuzumab is an investigational 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 mosunetuzumab 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 the GO29781 study The GO29781 study [NCT02500407] is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of mosunetuzumab 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 indolent (slow-growing) form of non-Hodgkin lymphoma (NHL), accounting for about one in five cases of NHL.[1] It is considered incurable and relapse is common. It is estimated that more than 100,000 people are diagnosed with FL each year worldwide, including over 28,000 people in Europe.[1,2] About Roche in haematology Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 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® (rituximab), Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclyxto® (venetoclax) in collaboration with AbbVie, and Hemlibra® (emicizumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, 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.

CHMP recommends EU conditional approval of Roche's potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma

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Biotech stocks are hard for novice investors to successfully profit from, but it's worth your time to learn the techniques now. The post Recession Fears are Creating a Golden Opportunity for Biotech Stocks appeared first on InvestorPlace.

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Roche (RHHBY) sBLA is seeking approval for the intravenous formulation of arthritis drug Actemra accepted and granted Priority Review in the United States.

Roche (RHHBY) Actemra Application Receives Priority Review

New diagnostics solutions will be presented that help clinicians improve patient care and support healthcare systems. Participants can join virtually or onsite to learn about timely healthcare topics related to value-based healthcare, digital health and diagnostic technologies.

Roche to showcase the future of diagnostic solutions at EuroMedLab, 10 to 14 April 2022 Munich at ICM International Congress Center

Basel, 04 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra®/RoActemra® (tocilizumab) intravenous for the treatment of COVID-19 in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. A decision on U.S. FDA approval is expected in the second half of this year.

U.S. FDA grants priority review to Roche's Actemra/RoActemra 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 accepted the company's supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra® (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical v

U.S. FDA Grants Priority Review to Genentech's Actemra for the Treatment of COVID-19 in Hospitalized Adults

Basel, 04 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new OCREVUS® (ocrelizumab) data that show its benefit on disease progression and cognitive outcomes in primary progressive multiple sclerosis (PPMS) and secondary progressive MS (SPMS). Separate analyses on treatment disparities among newly diagnosed patients with MS by race and ethnicity will be a platform presentation at the 74th American Academy of Neurology (AAN) Annual Meeting 02–07 April 2022 in Seattle. CONSONANCE data will be presented virtually at AAN 24-26 April 2022.

New data for Roche's OCREVUS (ocrelizumab) show benefit in disability progression and cognitive decline in both secondary progressive and primary progressive multiple sclerosis

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new Ocrevus® (ocrelizumab) data that show its benefit on disease progression and cognitive outcomes in primary progressive multiple sclerosis (PPMS) and secondary progressive MS (SPMS). Separate analyses on treatment disparities among newly diagnosed patients with MS by race and ethnicity will be a platform presentation at the 74th American Academy of Neurology (AAN

New Data for Genentech's Ocrevus (ocrelizumab) Show Benefit in Disability Progression and Cognitive Decline in Both Secondary Progressive and Primary Progressive Multiple Sclerosis

Roche (RHHBY) phase III SKYSCRAPER-02 study assessing tiragolumab plus Tecentriq and chemotherapy as a first-line treatment for extensive-stage small cell lung cancer did not meet co-primary endpoint of progression-free survival.

Roche (RHHBY) Late-Stage Study for ES-SCLC Fails to Meet Goal

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III SKYSCRAPER-02 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq® (atezolizumab) and chemotherapy (carboplatin and etoposide) as an initial (first-line) treatment for people with extensive-stage small cell lung cancer (ES-SCLC), did not meet its co-primary endpoint of progression-free survival. The co-primary

Genentech Provides Update on Phase III SKYSCRAPER-02 Study in Extensive-Stage Small Cell Lung Cancer

Ad hoc announcement pursuant to Art. 53 LR

Ad hoc announcement pursuant to Art. 53 LR Roche provides update on phase III SKYSCRAPER-02 study in extensive-stage small cell lung cancer

Roche is "losing money in Russia", Chief Executive Severin Schwan said in an interview published on Tuesday, but remains committed to providing medication to patients there.

Roche loses money in Russia, chief executive says

Basel, 25 March 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Polivy® (polatuzumab vedotin) in combination with MabThera® (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL). Polivy plus R-CHP is the first treatment regimen to significantly improve outcomes in this disease in more than 20 years. A final decision regarding the approval of this Polivy combination is expected from the European Commission in the near future. DLBCL is the most common form of non-Hodgkin lymphoma and it is estimated 40,000 people in Europe are diagnosed with the disease each year.[3,4] Approximately four out of ten patients will relapse after first line treatment and the majority of patients who require subsequent lines of therapy have poor outcomes.[1,2] “A significant proportion of people newly diagnosed with diffuse large B-cell lymphoma, an aggressive form of blood cancer, do not respond adequately to existing therapies,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “Therefore, more treatment options are needed that could increase a person's chance of cure, and we look forward to bringing this new Polivy combination to people with DLBCL as soon as possible.” The CHMP opinion was based on efficacy and safety data from the phase III POLARIX study (GO39942), comparing Polivy in combination with chemotherapy regimen R-CHP versus the standard of care MabThera plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in treatment of first-line DLBCL. The study showed significantly higher progression-free survival (PFS) versus R-CHOP after a median follow-up of 28.2 months (hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57–0.95; P

CHMP recommends EU approval of Roche's Polivy combination for people with previously untreated diffuse large B-cell lymphoma

Basel, 25 March 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data for its approved and investigational medicines across neurological disorders will be presented at the 74th American Academy of Neurology (AAN) Annual Meeting being held 02-07 April in Seattle and virtually 24-26 April 2022. These data include twenty-four abstracts highlighting Roche's expansive neuroscience portfolio across five therapeutic areas, including OCREVUS® (ocrelizumab) in relapsing, secondary and primary progressive multiple sclerosis (RMS, SPMS and PPMS), EVRYDSI™ (risdiplam) in spinal muscular atrophy (SMA), ENSPRYNG™ (satralizumab) in neuromyelitis optica spectrum disorder (NMOSD), along with data from investigational programs in Alzheimer's disease (AD) and Duchenne muscular dystrophy (DMD).

Roche to present data across broad and impactful neuroscience portfolio at 2022 AAN Annual Meeting

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new data for its approved and investigational medicines across neurological disorders will be presented at the 74th American Academy of Neurology (AAN) Annual Meeting being held April 2-7 in Seattle and virtually April 24-26, 2022. These data include twenty two abstracts highlighting Genentech's expansive neuroscience portfolio across multiple therapeutic areas, inc

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