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.

Biogen

BioMarin Pharmaceutical

Eli Lilly

Ultragenyx Pharmaceutical

FDA approval of Biogen's Aduhelm for Alzheimer's should be broadly supportive of biotechnology and pharmaceutical stocks as it signals the agency is willing to be flexible to make important drugs. The rerating of Biogen shares following the FDA decision demonstrates the potential of innovation in the biopharmaceutical industry to generate significant alpha for investors.

Alzheimer's Approval Validates Biopharmaceutical Innovation

The FDA has granted Emergency Use Authorization (EUA) to Roche Holding AG's (OTC: RHHBY) Cobas SARS-CoV-2 Nucleic acid test for use on the Cobas Liat System. This singleplex test is the first real-time RT-PCR test to identify SARS-CoV-2 infection within 20 minutes, both asymptomatic and symptomatic persons.

Roche's New COVID-19 Point Of Care Test Scores FDA Emergency Use Nod

BASEL, Switzerland, June 18, 2021 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the cobas® SARS-CoV-2 Nucleic acid test for use on the cobas® Liat® System. This singleplex test is the first real-time reverse transcriptase polymerase chain reaction (RT-PCR) test that can identify SARS-CoV-2 infection within 20 minutes.

Roche SARS-CoV-2 molecular test granted first FDA Emergency Use Authorization for PCR testing of both symptomatic and asymptomatic individuals at the point of care

Synlogic

Synlogic Inc (NASDAQ: SYBX) has entered into a research collaboration agreement with Roche Holding AG (OTC: RHHBY) for the discovery of Synthetic Biotic medicine for inflammatory bowel disease (IBD). Under the terms of the agreement, Synlogic and Roche will collaborate to develop a Synthetic Biotic treatment addressing an undisclosed novel target in IBD.

Synlogic, Roche Ink Research Pact For Inflammatory Bowel Disease Therapy

Basel, 15 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that data across its growing neuroscience portfolio will be presented at the 7th Congress of the European Academy of Neurology (EAN) Annual Meeting being held virtually 19-22 June, 2021. These new and encore data demonstrate Roche's commitment to advancing the clinical understanding of a broad range of neurological disorders with the goal of meeting the needs of people living with both the rarest and most common conditions.“ Our data at EAN and recent European regulatory milestones for EVRYSDI and ENSPRYNG reflect our continued commitment to discovering and developing breakthrough medicines for challenging neurological conditions.” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We are honoured to work with our partners and the broader community to accelerate progress across our neuroscience portfolio with the goal of transforming the lives of many people living with neurological disorders.” Spinal Muscular Atrophy (SMA) Roche will present updated data from across the extensive EVRYSDI™ (risdiplam) clinical development programme, designed to represent a broad spectrum of people living with SMA, including those who have previously been treated with another SMA medication. Among the five abstracts featured, new data includes 12-month safety, pharmacodynamic and interim exploratory efficacy data from the JEWELFISH study of EVRYSDI in people previously treated with SMA-targeting therapies across a broad range of ages (1–60 years), SMA types (1–3) and SMN2 copy number (1-5). Data from SUNFISH Part 2 supporting the safety profile and efficacy of EVRYSDI in people aged 2-25 years with SMA Types 2 or non-ambulant Type 3 after two years of treatment will also be shared, as well as updated 2-year safety and efficacy data from the pivotal FIREFISH Parts 1 and 2 showing continued improvements in survival and motor milestones in infants aged one to seven months with Type 1 SMA. In addition, preliminary safety and efficacy data from the RAINBOWFISH study of EVRYSDI treatment in pre-symptomatic babies from birth to six weeks will be presented, along with longer-term safety data from a separate pooled analysis of the FIREFISH, SUNFISH, JEWELFISH and RAINBOWFISH trials. EVRYSDI, the first and only at home SMA treatment, is now approved in 42 countries, including the U.S. and EU. More than 3,000 patients have been treated with EVRYSDI in clinical trials, compassionate use and real-world settings.

Roche data at EAN 2021 showcase significant impact of therapies across diverse neuroscience portfolio

Basel, 11 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the latest data from three pivotal phase III studies of Venclexta®/Venclyxto® (venetoclax) – CLL14, MURANO and VIALE-A – to be presented at the European Hematology Association Virtual Congress, June 9-17 (EHA2021). Long-term follow-up data from the CLL14 and MURANO studies support the primary analysis of Venclexta/Venclyxto in chronic lymphocytic leukaemia (CLL) and the possibility of tailoring treatment approaches based on genetic risk factors. Furthermore, the latest research shows the potential of minimal residual disease (MRD) as a key measure of disease response in CLL and acute myeloid leukaemia (AML).

Roche announces data at EHA2021 reinforcing efficacy of Venclexta/Venclyxto combinations in chronic lymphocytic leukaemia and acute myeloid leukaemia

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the latest data from three pivotal Phase III studies of Venclexta® (venetoclax) – CLL14, MURANO and VIALE-A – to be presented at the European Hematology Association Virtual Congress, June 9-17 (EHA2021). Long-term follow-up data from the CLL14 and MURANO studies support the primary analysis of Venclexta in chronic lymphocytic leukemia (CLL) and the possibility of ta

Genentech Announces Data at EHA2021 Reinforcing Efficacy of Venclexta Combinations in Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia

Basel, 11 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new interim data from two studies of Evrysdi® (risdiplam); JEWELFISH and RAINBOWFISH. Data from JEWELFISH, an ongoing open-label study primarily evaluating the safety of Evrysdi in people aged 1 to 60 years who have been previously treated with another SMA-targeting therapy, including nusinersen and onasemnogene abeparvovec, showed the safety profile of Evrysdi and increase in SMN protein levels are consistent with those observed in other Evrysdi studies.

New Roche data for Evrysdi show improved motor function in pre-symptomatic babies after one year and confirm safety profile in previously treated people with 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 interim data from two studies of Evrysdi® (risdiplam); JEWELFISH and RAINBOWFISH. Data from JEWELFISH, an ongoing open-label study primarily evaluating the safety of Evrysdi in people aged 1 to 60 years who have been previously treated with another SMA-targeting therapy, including nusinersen and onasemnogene abeparvovec, showed the safety profile of Evrysdi and

New Genentech Data for Evrysdi (risdiplam) Show Improved Motor Function in Pre-Symptomatic Babies After One Year and Confirm Safety Profile in Previously Treated People With Spinal Muscular Atrophy (SMA)

Basel, 08 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has received CE mark for its SARS-CoV-2 Antigen Self Test Nasal for at-home testing. The test will be available in countries accepting the CE mark through pharmacies and other locations, in packs of five tests. An early version of the test has already been available as a home-test in a number of European markets under local special approval pathways since February 2021. With the CE Mark, the SARS-CoV-2 Antigen Self Test Nasal for rapid self testing of COVID-19 test has received official approval following the traditional registration pathway and can now also be used in markets that have not established regulatory exemption pathways. By following simple instructions, individuals can perform the test at home using a nasal swab without special training or the supervision of a healthcare worker. The test provides results in as little as 15 minutes and can help people to conveniently check if they are likely to be infectious from the comfort of their home. In the case of children under 18 years of age, the test must be performed by an adult or under close adult supervision. As societies begin to reopen and in line with local health regulations, the convenient test allows individuals planning to attend an event or gathering to use the test as a tool to confirm that they are not likely to be carriers of a substantial amount of the virus thus helping them make informed decisions and reduce the risk of transmission to others. Complementary to the SARS-CoV-2 Antigen Self Test Nasal, Roche is offering NAVIFY® Pass. This digital solution allows individuals and healthcare professionals to remotely store, display, and share their COVID-19 test results and vaccine status through a personalised QR code. Having easy digital access to test results and vaccination status could potentially be used by both individuals and companies to facilitate access to locations with COVID-19 entry protocols, such as restaurants or entertainment venues, as well as to validate safety to travel. “As the world prepares to reopen, high-quality, home-based testing will play an important role in the battle against the pandemic,” said Thomas Schinecker, CEO, Roche Diagnostics. “Regular self-testing at home can reduce pressure on healthcare systems. It can quickly identify people with the highest potential to be infectious so they can take immediate action to seek medical advice, manage their infection and protect others.” This test is part of a partnership with SD Biosensor Inc., with whom Roche has also launched a SARS-CoV-2 Rapid Antibody Test in July 2020 and two SARS-CoV-2 Rapid Antigen Tests for professional use in September 2020 and February 2021. These tests will continue to play an important role in fighting this pandemic and remain available for healthcare professional testing. In addition to diagnostic testing, preventive measures remain key to protecting yourself and others against SARS-CoV-2. It is recommended to continue wearing masks, socially distance and practice good hygiene, especially if you have symptoms or known contact with others who have tested positive for the virus. Roche continues to expand its comprehensive COVID-19 portfolio to support healthcare systems in diagnosing SARS-CoV-2 infection. About the SARS-CoV-2 Antigen Self Test Nasal for at-home patient self-testing The SARS-CoV-2 Rapid Antigen Self Test Nasal is a rapid chromatographic immunoassay (lateral flow assay) for the detection of the nucleocapsid protein of SARS-CoV-2 in human nasal samples. Each test contains a unique QR code to enable individuals to share their test results and vaccine status using NAVIFY Pass, Roche's digital solution. For more information on NAVIFY Pass, visit www.navifypass.com The clinical performance of the test was measured by head to head comparison with Roche's highly sensitive reverse transcriptase polymerase chain reaction (RT-PCR) test using nasopharyngeal swab samples as a comparator, the gold standard sampling and detection method for SARS-CoV-2 detection.1,2 Combined study results showed that the relative sensitivity of the SARS-CoV-2 Antigen Self Test Nasal was 91.1%.** The overall relative specificity was 99.6 %,3 which represents the ability of the test to correctly identify patients without the virus. In one comparative independent self testing study where patients followed written and illustrated instructions to sample, test and read-out the results themselves, the majority of study participants considered the procedures easy to perform.4 About antigen testing An antigen test detects proteins which are structural or functional components of a pathogen and are very specific to that pathogen.5 In this case, the test would provide a qualitative “yes/no” answer on the presence of the antigen in the patient sample and can be offered as a rapid strip test that is performed at the point of care. If the target antigen (nucleocapsid protein) is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a visually detectable signal on the test strip, typically with results ready in 15 minutes. A rapid antigen test can reliably detect individuals with a high viral load allowing healthcare professionals to quickly identify those patients at the greatest risk of spreading the infection.6 About Roche's response to the COVID-19 pandemic The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need. This new test is an additional step in Roche's fight against the COVID-19 pandemic, which has already included:

Roche obtains CE mark for the SARS-CoV-2 Antigen Self Test Nasal allowing for rapid self testing of COVID-19 at home

Surface Oncology Inc

Surface Oncology (NASDAQ: SURF) has entered into a clinical trial collaboration with Roche Holdings AG (OTC: RHHBY) to evaluate former's SRF388, anti-IL-27 antibody, in combination with Roche's atezolizumab and bevacizumab in patients with treatment-naïve hepatocellular carcinoma (HCC). Atezolizumab plus bevacizumab has been shown to improve overall survival significantly and is the new standard of care for unresectable or metastatic HCC.

Surface Oncology, Roche Team Up to Develop SRF388 Combo Therapy for Liver Cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new data on its investigational CD20xCD3 T-cell engaging bispecific antibodies, mosunetuzumab and glofitamab, and its first-in-class anti-CD79b antibody-drug conjugate, Polivy® (polatuzumab vedotin), in non-Hodgkin's lymphoma (NHL) will be presented at the 2021 ASCO Annual Meeting from June 4-8, 2021. “People with difficult-to-treat blood cancers such as non-Ho

Genentech Presents Latest Advances With Immunotherapies in Non-Hodgkin's Lymphoma

The development of a versatile drug for oncological treatment could differentiate Roche's product from competitors. Its acquisitions are set to drive revenue growth in the molecular diagnostics business and entry into the fast-growing cystic fibrosis market.

Roche: Leading Pharmaceutical Company In The Next Decade

Roche is a major, well-known pharmaceutical company based in Basel, Switzerland. The business is under pressure from biosimilars, but I see several reasons to still like the company.

Roche Is Facing Challenges, But Could Still Be Perfect For Certain Investors

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Wide-Moat Stocks On Sale - The June 2021 Heat Map

AbbVie

The European Commission has approved AbbVie Inc's (NYSE: ABBV) Venclyxto (venetoclax) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML). Venclyxto is approved in combination with a hypomethylating agent, azacitidine or decitabine, in AML patients ineligible for intensive chemotherapy.

AbbVie-Roche Win European Approval for Venclyxto in Newly Diagnosed Acute Myeloid Leukemia

Basel, 25 May 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Venclyxto® (venetoclax) in combination with hypomethylating agents, azacitidine and decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.

European Commission approves Venclyxto-based combinations for adults with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy

Exelixis

Exelixis Inc (NASDAQ: EXEL) has announced results from cohort 6 of the COSMIC-021 Phase 1b trial evaluating Cabometyx (cabozantinib) in combination with Roche's Tecentriq (atezolizumab) in patients with locally advanced or metastatic solid tumors. Cohort 6 included patients with metastatic castration-resistant prostate cancer, who were previously treated with enzalutamide or abiraterone acetate.

Exelixis' Cabometyx, Roche's Tecentriq Combo Achieves 27% ORR in High-Risk Prostate Cancer Patients

Basel, 20 May 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced interim results from the Phase III IMpower010 study, showing for the first time that treatment with Tecentriq® (atezolizumab) following surgery and chemotherapy reduced the risk of disease recurrence or death (disease-free survival; DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88) in people with Stage II-IIIA non-small cell lung cancer (NSCLC), whose tumours express PD-L1≥1%, compared with best supportive care (BSC). In this population, median DFS was not yet reached for Tecentriq compared with 35.3 months for BSC.

Pivotal Phase III data at ASCO show Roche's Tecentriq helps certain people with early lung cancer live significantly longer without their disease returning

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 IMpower010 study, showing for the first time that treatment with Tecentriq® (atezolizumab) following surgery and chemotherapy reduced the risk of disease recurrence or death (disease-free survival; DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50-0.88) in people with Stage II-IIIA non-small cell lung cancer (NSCLC), whose tumors e

Pivotal Phase III Data at ASCO Show Genentech's Tecentriq Helps Certain People With Early Lung Cancer Live Significantly Longer Without Their Disease Returning

Analog Devices

Analog Devices, Inc. (ADI) CEO Vince Roche on Q2 2021 Results - Earnings Call Transcript

Roche Holdings AG's (OTC: RHHBY) Cobas SARS-CoV-2 Test has received U.S. authorization for testing individuals without symptoms or reasons to suspect a COVID-19 infection. “The high-throughput, highly sensitive Cobas SARS-CoV-2 Test under FDA Emergency Use Authorization can now be used to test individual or pooled samples from people without symptoms or other reasons to suspect COVID-19,” Roche said in a statement.

Roche's Cobas COVID Test Scores EUA For Asymptomatic People

PLEASANTON, Calif., May 18, 2021 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its cobas® SARS-CoV-2 Test for use on the widely available, high-throughput cobas® 6800/8800 Systems has received Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA) for testing individuals without symptoms or reasons to suspect COVID-19.

Roche receives FDA authorisation for testing of asymptomatic people with the cobas SARS-CoV-2 Test to help control the spread of COVID-19

Basel, 11 May 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from clinical trials of 19 approved and investigational medicines across 20 cancer types will be presented at the 2021 ASCO Annual Meeting, which will be held 4-8 June, 2021. A total of 132 abstracts that include a Roche medicine will be presented at this year's meeting. These data advance oncology by showing the importance of making patient-centric treatment decisions and providing tailored medical care based on specific cancer types. “We will be presenting data from across our diverse oncology portfolio that has the potential to help more people living with many types of cancers,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We are particularly excited about our compelling immunotherapy data in lung cancer, which may provide new hope for patients with earlier stage disease.” Focusing on earlier treatment and targeted lung cancer care Positive results from the phase III IMpower010 study will be presented that show Tecentriq® (atezolizumab) improved disease-free survival (DFS) in people with resectable early-stage non-small cell lung cancer (NSCLC) compared to best supportive care - a first in cancer immunotherapy. This advance is significant, as half of all people with early stage lung cancer today still experience a recurrence following surgery; therefore, treating lung cancer early, before it has spread, can provide the best opportunity for a cure. Additionally, updated data for Gavreto® (pralsetinib) in patients with advanced RET fusion-positive NSCLC, including in patients who are treatment naïve, will be reported. These data highlight the need for early RET fusion-positive testing to identify candidates who may benefit from treatment with Gavreto. Exploring personalised cancer care for more patients Roche will present several studies that take tumour-agnostic approaches to clinical development, and in breast cancer, that may benefit people with rare and common tumours alike. These studies bring together       next-generation sequencing, targeted therapies and patient-centric clinical trial design that show how personalised treatment plans are helping to evolve the way people are treated. The phase II ALPHA-T study, made possible through a collaboration with Foundation Medicine and Science37, is pioneering a decentralised approach to clinical trial design which enables patients to participate from their own homes while remaining under the care of their oncologist. The phase II TAPISTRY study, a platform umbrella trial, will pair patients with immunotherapy, targeted therapy or treatment combinations based on distinct tumor biology characteristics. The similarly designed phase II MyTACTIC study is enrolling a diverse population of patients to direct them to appropriately targeted treatments based on the results of comprehensive genomic profiling. With our research we are contributing to the body of evidence in hormone receptor (HR)-positive breast cancer, the most prevalent type of all breast cancers. For giredestrant, a third generation oral selective oestrogen receptor degrader (SERD), we will present data further supporting the tolerable safety profile and single agent clinical activity, as well as pharmacodynamics data from studies in HR-positive early and metastatic breast cancer. Defining new solutions for patients with difficult-to-treat blood cancer New and updated data in non-Hodgkin lymphoma (NHL) will be shared, including data from the T-cell engaging CD20xCD3 bispecific antibody development programme. Glofitamab and mosunetuzumab are both T-cell engaging CD20xCD3 bispecific antibodies that are being studied as single agents or in combination with other Roche therapies. Together, they may offer a new immunotherapy based approach to tackle a range of blood cancers. In addition, data exploring novel combinations with mosunetuzumab and Polivy® (polatuzumab vedotin), an antibody drug conjugate, will also be featured. These data demonstrate how Roche continues to seek new solutions for people living with a range of malignant blood disorders, where treatment options are still limited and both relapse and treatment resistance are common. Furthermore, Roche's data showcase a commitment to health equity through medicine delivery approaches that reduce treatment time and cost, trial designs that help remove barriers to clinical trial participation, pioneering cancer immunotherapy to improve outcomes for earlier disease stages, and a focus on inclusivity through developing tumour-specific therapies and therapy combinations based on specific characteristics of each person's disease. Roche will be launching an Oncology Newsroom for journalists to access exclusive materials sharing insights into Roche's latest data, vision and strategy to pursue and advance scientific progress in order to improve the lives of people living with cancer. The newsroom will be available on Tuesday 1 June, and is open to journalists from outside the United States. To access the newsroom, please register via this link: https://oncologyresearchmedia.roche.com. Keep up to date with ASCO news and updates by using the hashtag #ASCO21 and follow Roche on Twitter via @Roche and LinkedIn . Overview of key presentations featuring Roche medicines

Roche to present data from one of the most comprehensive oncology portfolios at the 2021 ASCO Annual Meeting showcasing advancements for people living with cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new data from clinical trials of 19 approved and investigational medicines across 20 cancer types will be presented at the 2021 ASCO Annual Meeting, which will be held June 4-8, 2021. A total of 132 abstracts that include a Genentech medicine will be presented at this year's meeting. These data advance oncology by showing the importance of making patient-centri

Genentech to Present Data From One of the Most Comprehensive Oncology Portfolios at the 2021 ASCO Annual Meeting Showcasing Advancements for People Living With Cancer

News for Roche Holding AG Stock (RHHBY)