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, 12 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours. This marks the first single-dose oral influenza medicine approved in the US for children in this age group. Additionally, the FDA approved Xofluza for the prevention (post-exposure prophylaxis) of influenza in children aged five to less than 12 years of age following contact with someone with influenza.

Roche announces U.S. FDA approval of Xofluza to treat influenza in children aged five years and older

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 a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours. This marks the first single-dose oral influenza medicine

Genentech Announces FDA Approval of Xofluza to Treat Influenza in Children Aged Five and Older

Based on cancer biomarkers, the first-of-its-kind VENTANA MMR RxDx Panel helps identify solid tumour patients, including endometrial cancer patients, for treatment with Merck's immunotherapy KEYTRUDA. The test evaluates a panel of MMR proteins in tumours to provide important treatment information to clinicians.

Roche receives FDA approval for VENTANA MMR RxDx Panel to identify dMMR solid tumour patients and pMMR endometrial cancer patients eligible for KEYTRUDA

Poseida Therapeutics

Source: Shutterstock Poseida Therapeutics (NASDAQ: PSTX ) stock is soaring on Wednesday after the clinical-stage biotechnology company announced a deal with Roche (OTCMKTS: RHHBY ). The agreement with Roche will have it working with Poseida Therapeutics to develop “allogeneic CAR-T therapies directed to hematologic malignancies.

Poseida Therapeutics (PSTX) Stock Rockets 79% on Roche Deal

Basel, 2 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMscin001 study evaluating a subcutaneous formulation of Tecentriq® (atezolizumab) met its co-primary endpoints. The study showed non-inferior levels of Tecentriq in the blood (pharmacokinetics), when injected subcutaneously, compared with intravenous (IV) infusion, in cancer immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed. The safety profile of the subcutaneous formulation was consistent with that of IV Tecentriq.

Roche's subcutaneous formulation of Tecentriq demonstrates positive Phase III results

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMscin001 study evaluating a subcutaneous formulation of Tecentriq® (atezolizumab) met its co-primary endpoints. The study showed non-inferior levels of Tecentriq in the blood (pharmacokinetics), when injected subcutaneously, compared with intravenous (IV) infusion, in cancer immunotherapy-naïve patients with locally advanced or metastatic non-sma

Genentech's Subcutaneous Formulation of Tecentriq Demonstrates Positive Phase III Results

The company has posted growth despite lower demand for several key products.

How This Multibillion-Dollar Company Is Shaking Off the Competition

Basel, 28 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that data from 41 abstracts across its portfolio of Alzheimer's disease pharmaceuticals and diagnostics will be presented at the 2022 Alzheimer's Association International Conference (AAIC), which will be held in San Diego 31 July -4 August. Among the data are new presentations on Roche's investigational subcutaneously administered anti-amyloid monoclonal antibody gantenerumab and the Elecsys® Amyloid Plasma Panel. Additionally, detailed results from the Alzheimer's Prevention Initiative Autosomal Dominant Alzheimer's Disease (API ADAD) Trial evaluating the investigational monoclonal antibody crenezumab will be presented to inform future Alzheimer's prevention research.

Roche to present scientific progress across Alzheimer's disease pharmaceutical and diagnostic portfolio at 2022 AAIC Annual Meeting

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that data from 41 abstracts across its portfolio of Alzheimer's disease pharmaceuticals and diagnostics will be presented at the 2022 Alzheimer's Association International Conference (AAIC), which will be held in San Diego from July 31 - Aug. 4, 2022. Among the data are new presentations on Genentech's investigational subcutaneous anti-amyloid monoclonal antibody ga

Genentech to Present Scientific Progress Across Alzheimer's Disease Pharmaceutical and Diagnostic Portfolio at 2022 AAIC Annual Meeting

Basel, 22 July 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 adopted a positive opinion recommending the approval of Vabysmo®️ (faricimab) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). Based on this recommendation, a final decision regarding the approval of Vabysmo is expected from the European Commission in the near future.

CHMP recommends EU approval of Roche's Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss

Exhibit booth will highlight solutions that offer new ways to address today's most critical lab challenges and deliver better patient care. Roche will debut the Idea Lab series, where industry experts share insights on healthcare topics such as health equity, access, staffing pressures and data optimization.

Roche to showcase latest innovations in diagnostic solutions at American Association of Clinical Chemistry 2022 Clinical Lab Expo

Roche Holding AG (OTCQX:RHHBY) Q2 2022 Results Conference Call July 21, 2022 8:00 AM ET Company Participants Severin Schwan - CEO Bill Anderson - CEO, Roche Pharmaceuticals Thomas Schinecker - CEO, Roche Diagnostics Alan Hippe - CFO Bruno Eschli - Head, IR Conference Call Participants Jo Walton - Credit Suisse Wimal Kapadia - Bernstein Sachin Jain - Bank of America Richard Vosser - JPMorgan Keyur Parekh - Goldman Sachs Andrew Baum - Citi Emily Field - Barclays Stephen Scala - Cowen Mark Purcell - Morgan Stanley Operator Ladies and gentlemen, welcome to Roche's Half Year Results Webinar 2021. My name is Henrique and I am the technical operator for today's call.

Roche Holding AG (RHHBY) CEO Severin Schwan on Q2 2022 Results - Earnings Call Transcript

Roche (RHHBY) performance in the first half was decent on demand for its diagnostics base business and new drugs. Demand for COVID-19 tests is likely to fall in the second half.

Roche (RHHBY) 1H22 Earnings, Sales Grow, View Disappoints

Roche Holding AG said Thursday that profit for the first half of the year increased as sales grew, mainly driven by the diagnostics division.

Roche backs 2022 outlook as profit climbs, boosted by diagnostics sales

Roche said the head of its diagnostics division, Thomas Schinecker, is to become group chief executive next year, replacing Severin Schwan, who will take the role of chairman of the board of directors.

Roche diagnostics head to become group CEO

Roche's second-quarter adjusted operating income rose a better-than-expected 9% on higher sales of diagnostic tests and pharmaceuticals.

Roche core operating income up 9% in Q2

Basel, 21 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Christoph Franz has decided not to seek re-election to the Board of Directors at the AGM in March 2023. The Board of Directors intends to propose Severin Schwan as new Chairman at the AGM and has appointed Thomas Schinecker as new Roche CEO effective 15 March 2023. Christoph Franz was elected to the Roche Board of Directors in 2011 and has served as its Chairman since 2014: ”After serving twelve years on the Board of Directors, nine of which as Chairman, I have decided not to seek re-election to the Board next year. We have achieved many important milestones and with the conclusion of Roche's 125th anniversary, it is now the right time for a change in leadership. I am proud of the significant contributions Roche has made in fighting the pandemic during the last two and a half years. I am also pleased that we could secure long term stability in our shareholder structure with the repurchase of Roche shares from Novartis. With the strong pipelines of innovative products in both our Pharma and Diagnostic businesses, we are set for continued growth in the future.” The Roche Board of Directors will propose Severin Schwan as new Chairman at the AGM on 14 March 2023. Severin Schwan has been a member of the Corporate Executive Committee since 2006 and has served as CEO of the company since 2008. He has been a member of the Roche Board of Directors since 2013. Severin Schwan: ”I have very much appreciated the close and trusting collaboration with Christoph and would like to thank him. I am honoured to stand for the position of Chairman of the Roche Board of Directors and will continue to dedicate all my efforts to the future of this company.” André Hoffmann, Vice-Chairman of the Board of Directors and representative of the Oeri and Hoffmann shareholder group with pooled voting rights: “Thanks to Christoph's long term strategic vision, he has steered our company confidently and successfully through challenging times. Roche's continued success is in no small part due to his personal contributions. I would like to thank him sincerely, also in the name of our families. As in the past, we are able to secure the succession to the Chairman and CEO roles with excellent leaders from within Roche. This is a great quality of our company.” Effective 15 March 2023, the Board of Directors has appointed Thomas Schinecker, currently CEO of the Diagnostics Division, as CEO of Roche succeeding Severin Schwan. Thomas Schinecker holds a PhD in Molecular Biology and has been working for Roche in different leadership positions since 2003. He became CEO of the Diagnostics Division and a member of the Corporate Executive Committee in August 2019. Severin Schwan: ”I am very pleased that the Board has appointed Thomas as the new Roche CEO. He is a highly qualified successor who has been working for Roche in leadership positions around the globe for twenty years. Thomas successfully set up our Diagnostics Division for the future. Under his leadership our Diagnostics organisation also made considerable contributions in fighting the COVID-19 pandemic.” Thomas Schinecker: “I am deeply honoured by the Board's decision and the trust placed in me. I am delighted to carry on working closely with Roche colleagues and the Corporate Executive Committee. Like we've done for the last 125 years, I am excited about the future innovations we will bring to patients around the globe.” 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 endeavor 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. 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

[Ad hoc announcement pursuant to Art. 53 LR] Roche: Change in the Board of Directors and Corporate Executive Committee in Spring 2023

[Ad hoc announcement pursuant to Art. 53 LR] Roche achieves good results in the first six months of 2022

PITTSBURGH--(BUSINESS WIRE)--Avista today announced a partnership with Roche to develop novel AAV gene therapy vectors for the eyes.

Avista Therapeutics Partners with Roche to Develop Next-Generation AAV Gene Therapy Vectors for Ocular Diseases

Basel, 19 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Elecsys® Amyloid Plasma Panel, an innovative new solution to enable Alzheimer's disease to be detected earlier. The Elecsys Amyloid Plasma Panel test detects and measures Alzheimer's disease biomarkers in blood plasma to indicate the need for further confirmatory testing for Alzheimer's disease. Roche is the first in-vitro diagnostics manufacturer to receive this designation for a blood-based biomarker test for Alzheimer's. Alzheimer's disease is the most common form of dementia. Dementia affects more than 55 million people worldwide with more than 10 million new cases each year.1 Barriers to early and accurate diagnosis of Alzheimer's disease exist across the globe – up to 3 out of 4 people living with symptoms of Alzheimer's disease have not been diagnosed2, and those who have received a diagnosis, on average waited 2.8 years. "The key to transforming the life of people with Alzheimer's disease is to diagnose as early as possible and intervene with the right care plans,” said Thomas Schinecker, CEO of Roche Diagnostics. "Our new diagnostics test has the potential to streamline a patient's journey, improving speed and access toward a confirmatory diagnosis, giving people with Alzheimer's disease and their caregivers more time to plan and prepare for the future.” Currently, the diagnosis of Alzheimer's disease is largely based on clinical symptoms, including cognitive assessment, with a significant number of patients diagnosed when their disease has already advanced. The Elecsys Amyloid Plasma Panel will be the first qualitative test that combines the result of the phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human plasma. Elevations in pTau occur in early stages of Alzheimer's, while the presence of APOE E4 constitutes the most common genetic risk factor for Alzheimer's disease. Patients testing negative with the Elecsys Amyloid Plasma Panel are unlikely to be amyloid positive and should be investigated for other causes of cognitive decline. The Elecsys Amyloid Plasma Panel has thus the potential to ensure better identification of patients that require further confirmatory testing. This could be done via PET scan or cerebrospinal fluid (CSF) testing, supporting a more timely and accessible diagnosis. In conjunction with other diagnostic tools and the work Roche is doing in developing potential new treatments, this could be an important building-block toward improved care and outcomes for people with Alzheimer's disease. Roche has also received a Breakthrough Device Designation for the Elecsys® ß-Amyloid (1-42) CSF and Elecsys® Phospho-Tau (181P) CSF in vitro diagnostic immunoassays measuring ß-Amyloid (1-42) and Phospho-Tau concentrations in cerebrospinal fluid (CSF) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) or other causes of dementia. About the Elecsys® Amyloid Plasma Panel The Elecsys Amyloid Plasma Panel measures phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human blood plasma. Elevations in pTau occur in early stages of Alzheimer's, while the presence of APOE E4 constitutes the most common genetic risk factor for Alzheimer's disease. The result is intended for consideration in conjunction with other clinical information to advise for further confirmatory testing with amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) testing. Patients testing negative with the Elecsys Amyloid Plasma Panel are unlikely to be amyloid positive and should be investigated for other causes of cognitive decline. About Alzheimer's disease Alzheimer's is a progressive, fatal disease of the brain that gradually destroys memory, thinking skills and problem solving and impairs daily functioning such as the ability to manage one's own activities. Biological changes are believed to start decades before clinical symptoms of Alzheimer's become evident. Early signs and symptoms include memory loss, changes in mood or personality, decreased judgement, confusion, and challenges with problem-solving, finding the right word or familiar tasks. Alzheimer's disease is the most common form of dementia. Dementia affects more than 55 million people worldwide with more than 10 million new cases each year. Up to 3 in 4 people with dementia worldwide have not been diagnosed. Roche has an extensive Alzheimer's portfolio, including technology designed to more effectively detect and diagnose Alzheimer's disease and monitor disease progression and multiple treatment approaches and molecules that may address key pathways of Alzheimer's disease. Data from two Phase III studies with Roche's investigational treatment, gantenerumab, in early Alzheimer's disease are anticipated in November 2022. About the Breakthrough Device Designation The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. This program is designed to expedite the development and review of these medical devices. 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 recognizing our endeavor 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. For more information, please visit www.r oche.com . All trademarks used or mentioned in this release are protected by law. References [1] “Dementia.” World Health Organization, World Health Organization, 2 Sept. 2021, https://www.who.int/news-room/fact-sheets/detail/dementia#:~:text=Rates%20of%20dementia,and%20139%20million%20in%202050. [2] Alzheimer's Disease International. “Adi - over 41 Million Cases of Dementia Go Undiagnosed across the Globe – World Alzheimer Report Reveals.” Alzheimer's Disease International (ADI), 21 Sept. 2021, https://www.alzint.org/news-events/news/over-41-million-cases-of-dementia-go-undiagnosed-across-the-globe-world-alzheimer-report-reveals/. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relatio ns@roche.com

Roche's Elecsys Amyloid Plasma Panel granted FDA Breakthrough Device Designation to enable a timely diagnosis of Alzheimer's disease

Swiss pharma giant Roche's stock (OTCMKTS: RHHBY) has seen an 8% rise in a month, outperforming the broader S&P500 index, which remained flat.

What's Next For Roche Stock?

Basel, 18 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the Elecsys® HCV Duo immunoassay in countries that accept the CE Mark. Elecsys HCV Duo is the first available immunoassay that allows the simultaneous and independent determination of the hepatitis C virus (HCV) antigen and antibody status from a single human plasma or serum sample. This means that the test can be used to detect the early stage of infection, as well as when the patient is recovering from the virus, or showing signs of a chronic infection that may lead to other diseases, such as liver cancer.

Roche launches innovative dual antigen and antibody diagnostic test supporting the fight to eliminate the hepatitis C virus

Roche's (RHHBY) new two-year data reinforce the long-term efficacy, safety and durability of Vabysmo in wet age-related mtacular degeneration.

Roche (RHHBY) Announces 2-Year Data on Vabysmo for nAMD

Basel, 14 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit (IJB-CTSU) and Frontier Science Foundation (FS) today announced updated data from the phase III APHINITY study in HER2-positive early breast cancer. Results at 8.4 years median follow-up (101 months) showed the continued benefit of the combination of Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), versus Herceptin, chemotherapy and placebo, when given as post-surgery (adjuvant) intravenous (IV) treatment for people with lymph node (LN)-positive, HER2-positive early breast cancer, who are at high risk of recurrence. For patients with lymph node (LN)-positive disease, results showed a 28% reduction in the risk of recurrence or death, corresponding to an absolute benefit at eight years of 4.9% (invasive disease-free survival [iDFS], hazard ratio [HR]=0.72, 95% confidence interval [CI] 0.60-0.87). The safety profile was consistent with previous studies. Full findings were presented today at the European Society for Medical Oncology (ESMO) Virtual Plenary (VP6-2022).[3] “The eight-year APHINITY results show the great progress made in treating this aggressive form of early breast cancer,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “HER2-positive breast cancers are more likely than other subtypes to recur following surgery, so targeted treatment is critical to provide the best chance for a cure.” Prof. Sibylle Loibl, Chair of the German Breast Group (GBG) and the Chief Executive Officer of the GBG Forschungs GmbH, and APHINITY Study Chair, also commented: “These updated APHINITY data showed further reduction in the risk of cancer returning or death with a pertuzumab-based regimen in patients with LN-positive, HER2-positive early breast cancer, regardless of hormone receptor status. The trend towards a survival benefit was influenced by the LN-positive cohort and additional follow-up is very important to determine possible survival benefit and long-term safety of this regimen.” The third interim overall survival (OS) analysis of the APHINITY study was conducted after a median follow-up of 8.4 years (101 months), and also included updated results on iDFS and safety. The results showed remarkable outcomes consistent with prior analyses.[3,4,5] After eight years, results showed: [3]

Eight-year data from APHINITY study show Roche's Perjeta-based regimen continues to reduce the risk of disease returning for people with HER2-positive early breast cancer

Basel, 14 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new two-year data from the TENAYA and LUCERNE studies that reinforce the long-term efficacy, safety and durability of Vabysmo® (faricimab) in neovascular or “wet” age-related macular degeneration (nAMD), a leading cause of vision loss. 1 ,2 Neovascular AMD affects nearly 20 million people globally and can require treatment with eye injections every one to two months. 2 ,3,4 The two-year data were presented at the 2022 American Society of Retina Specialists Annual Scientific Meeting on 14 July. 1 “These longer-term results reinforce confidence in Vabysmo and support its continued use in people with neovascular AMD,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “With the potential to require fewer injections over time, Vabysmo continues to represent an important step forward for people with vision-threatening retinal conditions, and these data exemplify our commitment to redefining standards of care and reducing treatment burden.” In the TENAYA and LUCERNE studies, at two years:1

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