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, 26 November 2021 – On 4 November 2021, Roche (SIX: RO, ROG; OTCQX: RHHBY) had announced its agreement with Novartis Holding AG (Novartis) regarding the repurchase of the equity stake held by Novartis in Roche. At the same time, Roche had informed that the repurchase was conditional upon, inter alia, the approval by an Extraordinary General Meeting of Roche Holding Ltd of the capital reduction by cancellation of the shares to be repurchased from Novartis and of the interim financial statements prepared for the purpose of this transaction. At today's Extraordinary General Meeting of Shareholders, the Board of Directors therefore proposed the approval of a share capital reduction by cancellation of 53,309,000 bearer shares to be repurchased from Novartis and the approval of the interim financial statements prepared for the purpose of this transaction. Today's Extraordinary General Meeting of Roche approved all proposals of the Board of Directors. The shareholders approved the audited statutory interim financial statements (standalone financial statements) of the Company as of 31 October 2021 with a majority of 100.00% and the share capital reduction by cancellation of the 53,309,000 bearer shares with a nominal value of CHF 1 each to be repurchased from Novartis with a majority of 99.85%. Therefore, the corporate law requirements for the repurchase have been satisfied. The closing of the repurchase transaction is expected to take place in early December 2021. Christoph Franz, Chairman of Roche's Board of Directors: "Today's resolutions of the Extraordinary General Meeting are in the best economic and strategic interest of Roche. As a result, we will be even better positioned to make a contribution to the health of people around the world." In view of the tense pandemic situation and in accordance with applicable law, the Extraordinary General Meeting was held with only the persons in attendance required by law or the Articles of Incorporation at the premises of Roche Holding Ltd at its registered office without the physical attendance of shareholders. Shareholders were able to exercise their rights via written or electronic instructions to the independent proxy, Testaris AG. The independent proxy represented 85.5% of all 160,000,000 bearer shares. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, the company has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the thirteenth consecutive year, Roche has been recognised as one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com . All trademarks used or mentioned in this release are protected by law. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Roche Extraordinary General Meeting 2021

Analog Devices

Analog Devices, Inc. (ADI) CEO Vincent Roche on Q4 2021 Results - Earnings Call Transcript

Basel, 23 November 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its extensive haematology portfolio will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition from 11-14 December 2021. Roche molecules will be featured in more than 90 abstracts, including 17 oral presentations, showcasing new immunotherapies, unique treatment combinations, the application of novel endpoints, and fixed-duration regimens.

Roche to present new pivotal data at ASH 2021 from broad and comprehensive portfolio, challenging treatment standards for people with blood disorders

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its extensive hematology portfolio will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition from December 11-14, 2021. Genentech molecules will be featured in more than 90 abstracts, including 17 oral presentations, showcasing new immunotherapies, unique treatment combinations, the application of novel endpoints,

Genentech to Present New Pivotal Data at ASH 2021 From Broad and Comprehensive Portfolio, Challenging Treatment Standards for People With Blood Disorders

Roche (RHHBY) wins EC approval for Gavreto for the treatment of adults with RET fusion-positive advanced NSCLC.

Roche (RHHBY) Gets Approval for Gavreto for NSCLC in EU

MINNEAPOLIS--(BUSINESS WIRE)--Flywheel, the leading cloud-scale informatics platform for biomedical research and collaboration, announces a partnership with Roche and Genentech.

Flywheel Partners with Roche and Genentech to Accelerate Development of Personalized Healthcare Solutions

The European Commission (EC) has granted conditional marketing authorization to Roche Holdings AG's (OTC: RHHBY) Gavreto (pralsetinib) for treating adults with a form of non-small cell lung cancer. The approval covers pralsetinib as a monotherapy for treating adults with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

Roche's Gavreto Conditionally Approved In Europe For RET Fusion-Positive Lung Cancer

Basel, 19 November 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has granted conditional marketing authorisation for Gavreto® (pralsetinib) as a monotherapy for the treatment of adults with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. Gavreto is the first and only precision medicine approved in the European Union (EU) for the first-line treatment of people with RET fusion-positive advanced NSCLC.1

European Commission approves Roche's Gavreto (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer

Novartis

Novartis AG (NYSE: NVS) is getting a massive influx of cash from selling its 20-year stake in Roche Holdings AG (OTC: RHHBY), triggering speculation about where the Company will spend the money.  Another significant acquisition could be next.

Novartis Has $21B From Roche Stake Sale - Which Company Is On Its M&A Radar?

Spark Therapeutics, a unit of Roche Holdings AG (OTC: RHHBY), has announced data from its Phase 1/2 trial of SPK-8011 in hemophilia A.  At a median efficacy follow-up of 33.4 months, the study found that 16 of 18 study participants had sustained factor VIII (FVIII), which permitted prophylaxis cessation and reduction in bleeding episodes.

Spark Therapeutics' Hemophilia Gene Therapy Shows Reduction In Bleeding Episodes

Basel, 18 November 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the cobas ® 5800 System, a new molecular laboratory instrument, in countries accepting the CE mark. Testing is one of the first lines of defense to protect a patient's general well-being and is vitally important in quickly guiding their treatment. The cobas 5800 System helps address challenges that laboratories are facing from an increase in patient testing, reimbursement complexities and the need for a more diverse testing menu while providing meaningful and timely results.   “Diagnostics continue to revolutionise how providers care for patients, and it is essential, now more than ever, that the healthcare community has access to reliable and accurate testing solutions,” said Thomas Schinecker, CEO Roche Diagnostics. ”We are pleased that we can now offer a compact, fully-automated molecular system such as the cobas 5800 System. This new system helps to address the high demands on labs through greater efficiency, optimised workflows and cost savings, enabling them to deliver quality patient care.”  The cobas 5800 system, the newest member of the Roche Molecular Work Area, is built upon the innovation of the cobas ® 6800 and cobas ® 8800 systems, making molecular testing accessible to more patients around the world. Roche anticipates receiving U.S. Food and Drug Administration approval during Q3 2022. About the cobas 5800 System The cobas 5800 System is a real-time PCR molecular testing solution that provides excellent performance and value-added utility from a compact footprint. The cobas 5800 System delivers automation, consolidation, integration and standardisation – making it a scalable, cost-efficient solution for smaller labs seeking big lab performance, or for bigger labs seeking small lab agility. The system is built to offer a fully automated workflow that encompasses sample supply, transfer and preparation, amplification and detection, result calculation and delivery to the laboratory information system (LIS). The single module enables a walkaway time of up to eight hours*, resulting in less hands-on time, which can lead to improved productivity, reduced possibility for errors and more predictable turnaround times. The cobas 5800 System will offer the same menu as the cobas 6800 and 8800 Systems, including the cobas ® SARS-CoV-2 test. The system offers an expanded on board capacity allowing labs to test multiple assays simultaneously and delivers up to 144 results in an eight-hour shift. This streamlined molecular testing system will allow most labs to consolidate greater than 90 percent** of their routine molecular tests onto a single platform. For more information please visit diagnostics.roche.com. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, the company has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the thirteenth consecutive year, Roche has been recognised as one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com . All trademarks used or mentioned in this release are protected by law. *Walkaway time is dependent on the number of tests performed and number of runs initiated (under continuous testing conditions >96 tests per shift, walkaway time may be between 4 - 8 hours).**May vary based on assay availability in your country.

Roche launches cobas 5800, a new molecular diagnostics system to expand access to testing and improve patient care

Atea (AVIR) stock falls on termination of collaboration with Roche for the development of oral drug for the treatment of COVID-19.

Atea (AVIR) Plunges on Termination of Collaboration With Roche

Roche Holdings AG (OTC: RHHBY) has ended a partnership with Atea Pharmaceuticals Inc (NASDAQ: AVIR) to jointly develop a COVID-19 antiviral pill, a month after the drug failed in a small study. Roche and Atea teamed up last year to develop the oral treatment, AT-527, with Atea receiving an upfront payment of $350 million.

Atea Shares Plunge As Roche Culls Partnership To Develop COVID-19 Pill

Regeneron Pharmaceuticals

Regeneron (REGN) and partner Roche win the European Commission's approval for antibody cocktail to treat and prevent COVID-19.

Regeneron (REGN), Roche Get EC Nod for COVID-19 Cocktail

Roche's ADR reported its Q3 results last month with the top-line expanding 8% y-o-y, led by a 29% growth in new pharmaceuticals products, 18% growth in diagnostics, and 5% growth in other pharmaceuticals. The diagnostics business revenue was higher due to the spread of the Covid-19 Delta variant.

Here's Why Roche Stock May Continue To Trend Higher

Basel, 15 November 2021 - 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). This is based on an in-depth analysis of economic, social and environmental performance. The DJSI family of indices serves as a benchmark for investors who integrate sustainability considerations into their portfolios. Roche has maintained its leadership through its sustainability strategy, which is fully embedded in the company's business and culture. “We are proud of being recognised once again for our consistent and lasting engagement on sustainability,” says Roche CEO Severin Schwan. “This achievement strongly resonates in the context of our 125-year anniversary, and highlights our heritage and our continued commitment to society.” S ustainability at Roche For 125 years, sustainability has been an integral part of Roche's business. Roche follows a holistic approach when managing sustainability: In addition to improving access to products, the company's strategy also focuses on achieving continuous progress in areas such as social responsibility, environmental protection, supply chain sustainability, people attraction and retention. Roche makes its biggest contribution to society by improving healthcare provision. It does so by developing the best diagnostic tests and medicines capable of meeting some of the world's most pressing medical needs. Roche is aware that this cannot be done alone. The company knows that the key to creating sustainable value and growth lies in partnering with stakeholders and engaging in open, constructive dialogue. By doing so, Roche generates value for society and achieves sustainable economic growth for the company. Examples of our activities in sustainability areas can be found here: www.roche.com/sustainability About the Dow Jones Sustainability Indices (DJSI) This global ranking is published annually by the S&P Dow Jones Indices and SAM and measures the performance of the world's sustainability leaders. SAM invites publicly traded companies to participate. Companies are selected for the indices according to a systematic Corporate Sustainability Assessment (CSA) performed by SAM. Only firms that lead their industries based on this assessment are included in the indices. This is determined by a comprehensive assessment of long-term economic, environmental and social criteria that take account of general as well as industry-specific sustainability trends. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, the company has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the thirteenth consecutive year, Roche has been recognised as one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com . All trademarks used or mentioned in this release are protected by law. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Roche ranked as one of the top three most sustainable healthcare companies in the Dow Jones Sustainability Indices for the thirteenth year running

The European Commission (EC) has approved Regeneron Pharmaceuticals Inc's (NASDAQ: REGN) COVID-19 antibody cocktail, known as REGEN-COV in the U.S. and Ronapreve in the European Union (EU) and other countries. The authorization comes for people aged 12 years and older to treat non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19 and to prevent COVID-19.

Europe Approves Regeneron - Roche's COVID-19 Antibody Cocktail

Regeneron (REGN) and partner Roche obtain a positive opinion from CHMP for their antibody cocktail for the treatment of non-hospitalized patients with confirmed COVID-19 and to prevent the disease.

Regeneron (REGN)-Roche COVID-19 Cocktail Gets Positive CHMP Opinion

Basel, 12 November 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has granted a marketing authorisation for Ronapreve™ (casirivimab and imdevimab), for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe, and for preventing COVID-19 in people aged 12 years and older weighing at least 40 kilograms (pre- or post-exposure prophylaxis). This decision follows one day after the positive opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), reflecting the EMA and the European Commission's priority to shorten review timelines for safe, effective and high-quality therapeutics during the COVID-19 public health emergency.

Ronapreve approved by European Commission to treat non-hospitalised COVID-19 patients and for prophylaxis of the disease

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Regeneron Pharmaceuticals Inc's (NASDAQ: REGN) REGEN-COV. The casirivimab and imdevimab antibody cocktail (Ronapreve) was backed by the CHMP for treating adults and children over 12 with COVID-19 who do not require oxygen support and are at high risk of severe disease.

EU Regulator Backs Regeneron-Roche's COVID-19 Drug

Basel, 11 November 2021 - 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 the antibody combination, Ronapreve™ (casirivimab and imdevimab), for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe, and for preventing COVID-19 in people aged 12 years and older weighing at least 40 kilograms (pre- or post-exposure prophylaxis). A final decision regarding the approval of Ronapreve is expected from the European Commission in the near future.

CHMP recommends EU approval of Ronapreve to treat non-hospitalised COVID-19 patients and for prophylaxis of the disease

Roche Holding AG, still months away from seeking regulatory approval of its experimental Alzheimer's drug, is already taking aim at rival Biogen Inc's Aduhelm, saying that its medication would be priced competitively.

Roche executive says Alzheimer's drug price will be competitive

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) has announced additional results from a Phase 3 trial, which assessed a single dose of REGEN-COV (1,200 mg administered via 4 subcutaneous injections) to prevent COVID-19 in uninfected individuals.  The new analyses show REGEN-COV reduced the risk of contracting COVID-19 by 81.6% during the pre-specified follow-up period (months 2-8), maintaining the 81.4% risk reduction during the first month after administration.

Regeneron-Roche's COVID-19 Treatment Shows Long Term Benefit After Single Dose

Roche's $20.7 billion move to buy back nearly a third of its voting stock from fellow Swiss drugmaker Novartis will give it more strategic flexibility, Chairman Christoph Franz said in an interview published on Saturday.

Roche chairman sees greater flexibility after Novartis deal - paper

Roche said on Friday that its controlling family will be exempt from having to make an offer to other shareholders after the drugmaker's $20.7 billion deal to buy back Novartis's nearly one third voting stake.

News for Roche Holding AG Stock (RHHBY)