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.

Ionis Pharma

Ionis (IONS) stock sinks as partner Roche stops dosing in a late-stage study on tominersen in Huntington's disease.

Ionis (IONS) Crashes as Roche-Partnered Huntington's Drug Fails

Shares of Ionis Pharmaceuticals Inc. were down 19.6% in premarket trading on Tuesday, the day after the company said Roche Holding AG decided to discontinue a late-stage clinical trial for a Huntington's disease treatment candidate. Roche licensed the investigational therapy, tominersen, from Ionis in December 2017.

Ionis shares tumble19% after Roche halts Phase 3 study for rare-disease drug

Roche Holdings AG (OTCMKTS: RHHBY) has halted dosing for its Phase 3 study of tominersen, an antisense drug targeting the huntingtin protein and a mutant variant. Roche is calling off the study after an independent data committee “made its recommendation based on the investigational therapy's potential benefit/risk profile for study participants.

Ionis Pharma Stock Is Trading Lower After Roche Drops Huntington's Disease Trial With Tominersen

Basel, 23 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of eight new configurations for cobas pro integrated solutions, in countries accepting the CE mark. As a result, this analyser can deliver up to 4,400 tests per hour, doubling its previous testing capacity.1 This makes it the ideal choice for labs seeking greater flexibility in ramping up their testing capacity, to adapt to evolving clinical chemistry and immunochemistry testing needs. Today, the importance of accurate and timely diagnostic testing can be felt across the globe. Growing testing demands put laboratories under significant pressure to increase their testing volumes and operational efficiency, with fewer resources. At the same time, clinicians and patients rely on accurate and timely results to make informed decisions. To overcome these challenges, labs require reliable diagnostic solutions that ensure simplified testing, allowing for earlier diagnosis and improved patient care. “We are excited to release eight new high throughput configurations for cobas pro integrated solutions which have been designed to address the individual needs of healthcare professionals to maximise throughput and efficiency,” said Thomas Schinecker, CEO Roche Diagnostics. “By building on a system with proven reliability and performance, we continue to simplify laboratory operations so that patients can benefit from shorter time to results and faster treatment decisions.” cobas pro integrated solutions now offers the possibility to add two additional analytical units of cobas c 503 and/or cobas e 801, consolidating up to four analytical units on a single platform and thus serving the needs of high throughput labs.1 Labs can now benefit from eight new configurations, allowing them to better tailor their instrumentation to their individual needs.1 As a result, cobas pro integrated solutions can deliver up to 4,400 tests per hour, doubling its previous testing capacity.1 Running more tests across a broad range of disease areas including cardiology, oncology and infectious diseases, enables labs to further extend their value for physicians and patients. Furthermore, by consolidating a greater number of samples on a single platform and offering the industry's broadest clinical chemistry and immunochemistry assay menu of over 230 diagnostic tests, this analyser helps to simplify sample processing and laboratory workflows.2-4 About cobas pro integrated solutions Launched in 2018, cobas pro integrated solutions is a scalable and modular solution designed to achieve mid-to-high volume clinical chemistry and immunochemistry testing needs. It aims to increase efficiency with fast analytical units, intelligent sample routing, and short assay incubation times, with 93% of Roche immunoassays having reaction times of 18 minutes or less.5 This analyser features automated maintenance and cobas® AutoCal, an automated calibration procedure, to save hands-on time. Additionally, it incorporates cobas® SonicWash, an ultrasonic probe cleaning to ensure sample integrity. cobas pro integrated solutions provides fully standardised results and operation to cobas® pure integrated solutions. Together, they deliver a seamless experience and the highest level of standardisation using the same reagents and assay menu, delivering consistent results and operation, and therefore allow for flexible staff assignment and minimal training needs. It makes these systems also ideal candidates for integrated health networks and lab chains. cobas pro integrated solutions is fully compatible with the cobas® mobile solution, a tablet that integrates multiple Roche applications, allowing laboratory professionals to interact with the analyser from anywhere in the lab. With cobas pro integrated solutions, the required sample volume per test has been reduced on average by 43% compared to previous generation systems.6 Additionally, the plastic generated per test result has been reduced by up to 78% due to smaller reagent pack sizes with a higher number of tests per pack.7

Roche launches new high throughput configurations for cobas pro integrated solutions to increase testing efficiency

Basel, 23 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive topline results from the largest trial to date assessing a COVID-19 treatment in infected non-hospitalised patients (n=4,567; REGN-COV 2067). The phase III outcomes trial in high-risk non-hospitalised patients with COVID-19 met its primary endpoint, showing the investigational antibody cocktail of casirivimab and imdevimab reduced the risk of hospitalisation or death by 70% (1,200 mg intravenously [IV]) and 71% (2,400 mg IV) compared to placebo. Casirivimab and imdevimab also met all key secondary endpoints in the phase III REGN-COV 2067 trial, including the ability to reduce symptom duration from 14 to 10 days (median numbers). In addition, a companion phase II trial (REGN-COV 20145) in low risk symptomatic or asymptomatic non-hospitalised patients with COVID-19 showed significant and comparable viral load reductions across doses ranging from 300 to 2,400 mg. “Today's results show the important medical benefit casirivimab and imdevimab may provide to people with COVID-19 by significantly reducing their risk of hospitalisation and death,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “New infections continue to rise globally with over three million reported cases last week, so this investigational antibody cocktail may offer hope as a potential new therapy to high-risk patients - particularly in light of recent evidence showing that casirivimab and imdevimab together retain activity against key emerging variants. Together with our partner Regeneron, we are grateful to the patients and investigators who have participated in ongoing clinical trials and look forward to discussing the growing body of evidence with health authorities and to bringing the treatment to as many people as possible." In addition to these trials in non-hospitalised patients, the investigational antibody cocktail of casirivimab and imdevimab is currently being studied in a phase II/III clinical trial for the treatment of COVID-19 in hospitalised patients, the phase III open label RECOVERY trial of hospitalised patients in the UK, and a phase III trial for the prevention of COVID-19 in household contacts of infected individuals. As of March 2021, approximately more than 25,000 people have participated in casirivimab and imdevimab clinical trials. Detailed results from both trials (REGN-COV 2067 and REGN-COV 20145) will be shared with regulatory authorities and submitted for peer review as soon as possible. Regeneron will share new data with the U.S. Food and Drug Administration (FDA) and Roche and Regeneron will continue to work with the European Medicines Agency (EMA) and other health authorities across the globe. Earlier this year, the EMA's Committee for Medicinal Products for Human Use issued a scientific opinion under Article 5(3) of Regulation 726/2004, supporting the use of casirivimab and imdevimab as a treatment option for patients with confirmed COVID-19. In these exceptional times, Roche stands together with society, governments, healthcare providers and all those working to overcome the pandemic.

New phase III data shows investigational antibody cocktail casirivimab and imdevimab reduced hospitalisation or death by 70% in non-hospitalised patients with COVID-19

Basel, 22 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the decision to discontinue dosing in the Phase III GENERATION HD1 study of tominersen in manifest Huntington's disease (HD). The decision was based on the results of a pre-planned review of the data from the Phase III study conducted by an unblinded Independent Data Monitoring Committee (iDMC). The iDMC made its recommendation based on the investigational therapy's potential benefit/risk profile for study participants. No new or emerging safety signals were identified for tominersen in the review of the data from this study. Roche intends to continue following participants for safety and clinical outcomes, without the dosing of the investigational medicine or placebo. Once full data from the Phase III study are available and analysed, Roche will share learnings and future plans with the HD community. Dosing will be paused in the open-label extension study (GEN-EXTEND) of tominersen while data are carefully analysed to inform next steps on this study. “This is very unfortunate news to deliver on the tominersen Phase III study and we know it will be especially difficult for people with Huntington's disease to hear. The HD community currently has no treatments to stop or slow the progression of this rare neurodegenerative disease that impacts families across generations.” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “GENERATION HD1 is the largest clinical trial in Huntington's disease to date and we do know that the data generated will significantly advance our understanding of huntingtin-lowering as a potential treatment approach. We would like to thank all of the individuals and families participating in the study for their contribution, as well as the broader HD community for their commitment and collaboration.” The Phase I PK/PD study (GEN-PEAK) of tominersen and the observational Roche HD Natural History Study will continue. About tominersen and the clinical trials Tominersen, previously IONIS-HTTRx or RG6042, is an investigational antisense therapy designed to reduce the production of all forms of the huntingtin protein (HTT), including its mutated variant, mHTT. In December 2017, Roche licensed the investigational molecule from Ionis Pharmaceuticals.

Roche provides update on tominersen programme in manifest Huntington's disease

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today the decision to discontinue dosing in the Phase III GENERATION HD1 study of tominersen in manifest Huntington's disease (HD). The decision was based on the results of a pre-planned review of the data from the Phase III study conducted by an unblinded Independent Data Monitoring Committee (iDMC). The iDMC made its recommendation based on the investigational therapy's

Genentech Provides Update on Tominersen Program in Manifest Huntington's Disease

Roche's (RHHBY) Tecentriq meets primary endpoint of disease-free survival at the interim analysis in lung cancer patients.

Roche's (RHHBY) Tecentriq Meets Primary Goal in Lung Cancer Study

Basel, 22 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpower010 study evaluating Tecentriq® (atezolizumab), compared with best supportive care (BSC), met its primary endpoint of disease-free survival (DFS) at the interim analysis. Tecentriq showed a statistically significant improvement in DFS as adjuvant therapy following surgery and chemotherapy in all randomised Stage II-IIIA populations with non-small cell lung cancer (NSCLC). The magnitude of DFS benefit was particularly pronounced in the PD-L1-positive population. Follow-up will continue with planned analyses of DFS in the overall intent-to-treat (ITT) population, which at the time of analysis did not cross the threshold, and overall survival (OS) data, which were immature at the time of interim analysis. Safety for Tecentriq was consistent with its known safety profile and no new safety signals were identified. Results from the IMpower010 study will be presented at an upcoming medical meeting and submitted to health authorities globally, including the U.S. Food and Drug Administration and the European Medicines Agency. “With these landmark results, Tecentriq has become the first cancer immunotherapy to help many people with resectable early lung cancer live longer without their cancer returning," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We're excited by the clinical benefit adjuvant Tecentriq may bring to lung cancer patients, particularly in the PD-L1-positive population. We will submit these data to regulatory authorities as soon as possible.” Tecentriq has previously shown clinically meaningful benefit in various types of lung cancer, with five currently approved indications in markets around the world. It was the first approved cancer immunotherapy for front-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. Furthermore, Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across different lung, genitourinary, skin, breast, gastrointestinal, gynecological, 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 tumor types. About the IMpower010 study IMpower010 is a Phase III, global, multicentre, open-label, randomised study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomised 1,005 people with a ratio of 1:1 to receive either at most 16 cycles of Tecentriq or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomised Stage II-IIIA and ITT Stage IB-IIIA populations. Key secondary endpoints include OS in the overall study population, ITT Stage IB-IIIA NSCLC. About NSCLC Lung cancer is the one of the leading causes of cancer death globally.1 Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day.1 Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.2 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.2 About Tecentriq Tecentriq is a monoclonal antibody designed to bind with a protein called Programmed Death Ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person's immune system combats cancer more effectively. Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of NSCLC, SCLC, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma. In the US, Tecentriq is also approved in combination with Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma. About Roche in cancer immunotherapy Roche's rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time. In addition to Roche's approved PD-L1 checkpoint inhibitor, Tecentriq® (atezolizumab), Roche's broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies. To learn more about Roche's scientific-led approach to cancer immunotherapy, please follow this link: http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm 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 under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. 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. 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 twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals 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. References [1] World Health Organization: GLOBOCAN 2020 – Lung Cancer: Estimated cancer incidence, mortality and prevalence worldwide. [Internet; cited March 2021] Available from: http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. [2] American Cancer Society: What Is Lung Cancer? [Internet; cited March 2021]: Available from: https://www.cancer.org/cancer/lung-cancer/about/what-is.html. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Pivotal Phase III study shows Roche's Tecentriq helped people with early lung cancer live 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 that the Phase III IMpower010 study evaluating Tecentriq® (atezolizumab), compared with best supportive care (BSC), met its primary endpoint of disease-free survival (DFS) at the interim analysis. Tecentriq showed a statistically significant improvement in DFS as adjuvant therapy following surgery and chemotherapy in all randomized Stage II-IIIA populations with non

Pivotal Phase III Study Shows Genentech's Tecentriq Helped People With Early Lung Cancer Live Longer Without Their Disease Returning

I'm long Roche but expect limited stock price appreciation potential for 2021.

Investing In Roche Requires Patience For Pipeline To Unfold

Basel, 17 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of cobas pure integrated solutions in countries accepting the CE mark.3 This new compact analyser combines three technologies1 on a single platform helping to simplify daily operations in labs with limited space and resources.

Roche launches cobas pure integrated solutions analyser to help simplify operations in small to medium sized labs

Basel, 16 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its shareholders approved all proposals of the Board of Directors at its ordinary Annual General Meeting (AGM). Owing to the pandemic restrictions, the AGM was held with only those persons required by the Articles of Incorporation in attendance and with no shareholders physically present. Roche shareholders were able to exercise their rights via written or electronically submitted instructions to the independent proxy, Testaris AG. The independent proxy represented 84.58% of the total of 160,000,000 shares. The Management Report, the Annual Financial Statements and the Consolidated Financial Statements for 2020 were approved.

Roche Annual General Meeting 2021

Basel, 16 March 2021- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the cobas® SARS-CoV-2 Variant Set 1 Test to detect and differentiate mutations found in variants that originated in the UK (B.1.1.7), South Africa (B.1.351), and Brazil (P.1). This research use only laboratory test can be used to help scientists track mutation prevalence and to assess any potential impact on diagnostics, vaccines and therapeutics, providing crucial insight for healthcare systems in making appropriate measures to combat COVID-19. Variants of B.1.1.7, B.1.351 and P.1 lineage gained prominence in late 2020, with each carrying a number of genomic mutations. Among them, mutations E484K, N501Y and del 69-70 are located in the spike protein, the region that enables the virus to attach to and enter the human cell. Studies have suggested that these mutations may be linked to increased disease transmissibility, and possibly decreased therapeutic and vaccine efficacy.1-4 “Viruses naturally evolve over time. While most mutations do not have a clinical impact, some variants need to be tracked carefully as they seem to spread more easily and quickly,” said Thomas Schinecker, CEO Roche Diagnostics. “Continued surveillance is essential for public health. Our latest solution provides laboratories a fast and efficient way to investigate these variants found in infected individuals and the potential impact on existing therapies, vaccines and tests.” The cobas SARS-CoV-2 Variant Set 1 Test runs on the widely available, high-volume cobas® 6800/8800 Systems. Pre-optimised assay design, ready-to-use test cassettes and predefined software parameters enable laboratories to reduce testing complexity and increase walkaway time. It is important to note that Roche has confirmed its existing diagnostic tests to detect SARS-CoV-2 are not affected by known mutations and remain accurate and effective in detecting active infections. The company is conducting assessments on a regular basis and will continue to monitor as new variants arise. About SARS-CoV-2 Variants B.1.1.7, B.1.351 and P.1 First reported in the UK in December 2020, B.1.1.7 variant has quickly become the dominant circulating variant and has since been found in countries worldwide.1 B.1.1.7 carries a large number of mutations, eight of which are accumulated in the spike region. Preliminary studies have suggested that two such spike mutations, N501Y and del 69-70, are associated with increased transmissibility of the disease.2,3 Another variant, B.1.351, which arose independently from B.1.1.7, was reported in South Africa in December 2020. In addition to having mutation N501Y, B.1.351 carries another spike mutation E484K, which appears to evade the body's immune response, possibly diminishing vaccine efficacy.4 Variant P.1, a close relative to B.1.351, has several defining mutations including N501Y and E484K in the spike region. P.1 has been circulating in the Amazon region as of late 2020 and is thought to evade immunity generated after infection by other variants.5 About cobas SARS-CoV-2 Variant Set 1 Test cobas SARS-CoV-2 Variant Set 1 Nucleic Acid test for use with the cobas 6800/8800 Systems is an automated, multiplex, real-time reverse transcription polymerase chain reaction (RT-PCR) assay for the rapid in vitro qualitative detection and discrimination of select SARS-CoV-2 mutations E484K, N501Y and del 69-70. The test contains the respective primers and probes provided in the ready-made 384-test cassette. Automated data management is performed by the cobas 6800/8800 software, which assigns test results for all tests. Results can be reviewed directly on the system screen, and printed as a report. Roche is committed to providing additional variant tests as needed based on regular assessments of the infectious disease landscape. About cobas 6800/8800 Systems When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. With proven performance, absolute automation and unmatched flexibility delivering unparalleled throughput 24/7— cobas 6800/8800 Systems are designed to ensure a lab's long-term sustainability and success now, more than ever. Learn more now: www.cobas68008800.com. About Roche's response to the COVID-19 pandemic As a leading healthcare company we are doing all we can to support countries in minimising the impact of COVID-19. We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection in patients, as well as providing digital support to healthcare systems, and we continue to identify, develop and support potential therapies which can play a role in treating the disease. We understand the impact of COVID-19 goes beyond those who contract it, which is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. As we learn from the pandemic, we are partnering with governments and others to make healthcare stronger and more sustainable in the future. Our diagnostics solutions:

Roche launches SARS-CoV-2 variant test to help monitor emerging coronavirus mutations

Basel, 16 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new exploratory 2-year longer-term data from Part 2 of SUNFISH, a global placebo-controlled study evaluating Evrysdi™ (risdiplam) in people aged 2-25 years with Type 2 or non-ambulant Type 3 spinal muscular atrophy (SMA). The study suggests that gains in motor function observed with Evrysdi treatment at month 12 continued to improve or were maintained at month 24 across primary and secondary endpoint measures. Based on the natural history of the disease, people with Types 2 and 3 SMA who remain untreated decline in motor function over time. These data will be presented at the 2021 Muscular Dystrophy Association (MDA) Virtual Clinical & Scientific Conference taking place from March 15-18. “These results build on the one-year findings from the SUNFISH trial and importantly show the durability of improvement or stabilization of motor function through two years of treatment,” said SUNFISH principal investigator Eugenio Mercuri, M.D., Ph.D., Department of Pediatric Neurology, Catholic University, Rome, Italy. “In addition, with no new safety signals identified, these second year results may support the favorable benefit-risk profile of Evrysdi over a longer period of time.” Patients in SUNFISH Part 2 ranged in age from 2-25 and were treated with Evrysdi (n=120) or placebo and Evrysdi (n=60; patients in the placebo arm received placebo for 12 months followed by Evrysdi treatment for 12 months). The study evaluated a number of exploratory 24-month endpoints, which provide important insights into motor function and its impact on daily life. Findings demonstrated that Evrysdi:

New two-year data show Roche's Evrysdi (risdiplam) continues to demonstrate improvement or maintenance of motor function in people aged 2-25 with Type 2 or Type 3 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 exploratory 2-year longer-term data from Part 2 of SUNFISH, a global placebo-controlled study evaluating Evrysdi™ (risdiplam) in people aged 2-25 years with Type 2 or non-ambulant Type 3 spinal muscular atrophy (SMA). The study suggests that gains in motor function observed with Evrysdi treatment at month 12 continued to improve or were maintained at month 24 ac

New 2-Year Data Show Genentech's Evrysdi (risdiplam) Continues to Demonstrate Improvement or Maintenance of Motor Function in People Aged 2-25 With Type 2 or Type 3 Spinal Muscular Atrophy (SMA)

GenMark Diagnostics

A healthcare titan is acquiring the diagnostic-test maker for a hefty premium.

Why GenMark Stock Soared Today

Shares of U.S.-based GenMark were shooting higher on Monday, after Swiss pharmaceutical group Roche said it will buy the California-based company.

GenMark Shares Surge After Roche Announces $1.8 Billion Deal for Molecular Test Maker

Roche (RHHBY) signs an agreement to acquire GenMark Diagnostics to test a broad range of pathogens using one patient sample. The deal is valued at around $1.8 billion on a fully diluted basis.

Roche (RHHBY) Inks Deal to Acquire GenMark Diagnostics for $1.8B

Roche Holding AG (SWX: RO) said on Monday that it will buy GenMark Diagnostics (NASDAQ: GNMK) for £1.29 billion. The all-cash deal translates to £17.25 per share.

Roche to buy U.S. based GenMark Diagnostics for £1.29 billion

Swiss drug giant Roche Holding AG (OTC: RHHBY) announced a big-ticket acquisition that would boost its presence in the diagnostics market, setting the tempo for a merger Monday. What Happened: Roche said it has entered into a definitive agreement to acquire GenMark Diagnostics (NASDAQ: GNMK) for $24.05 per share in cash, or about $1.8 billion, on a fully diluted basis.

Roche Boosts Diagnostics Portfolio With $1.8B Bet On COVID-19 Test Manufacturer GenMark

Roche will buy GenMark Diagnostics, a U.S.-based maker of molecular diagnostic tests in a $1.8 billion deal, the Swiss pharmaceuticals manufacturer said on Monday.

Roche agrees to buy GenMark Diagnostics in $1.8 billion deal

Basel, 15 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and GenMark Diagnostics (NASDAQ: GNMK) today announced that they have entered into a definitive merger agreement for Roche to fully acquire GenMark at a price of US$ 24.05 per share in an all-cash transaction. This corresponds to a total transaction value of approximately US$ 1.8 billion on a fully diluted basis. This price represents a premium of approximately 43% to GenMark's unaffected closing share price on February 10, 2021, the last trading day before a media report was published speculating about a potential sale process. The merger agreement has been unanimously approved by the boards of directors of GenMark and Roche. Once the acquisition is completed, GenMark's principal operations will continue at its current location in Carlsbad, California, USA. Under the terms of the merger agreement, Roche will promptly commence a tender offer to acquire all outstanding shares of GenMark's common stock, and GenMark will file a recommendation statement containing the unanimous recommendation of the GenMark board that GenMark stockholders tender their shares to Roche. GenMark's syndromic panel testing portfolio will complement Roche's current molecular diagnostics portfolio and the Roche global network will enable expanded reach for GenMark's products. GenMark's ePlex system drives lab efficiency through streamlined order-to-reporting workflow and enables better patient outcomes by rapidly diagnosing a patient's symptoms. Infectious diseases are a leading cause of death globally, and earlier detection of the cause of an infection has been shown to improve patient outcomes and improve key hospital initiatives such as antibiotic stewardship and length of stay. “Acquiring GenMark Diagnostics will broaden our molecular diagnostics portfolio to include solutions that can provide lifesaving information quickly to patients and their healthcare providers in the fight against infectious diseases,” said Thomas Schinecker, CEO Roche Diagnostics. “Their proven expertise in syndromic panel testing provides faster targeted therapeutic intervention, resulting in improved patient outcomes and reduced hospital stays, and will contribute to Roche's commitment to helping control infectious diseases and antibiotic resistance. The rapid identification of bloodstream infections and the detection of antimicrobial resistance genes are more essential than ever for hospitals and their patients.” “As a part of Roche, we can accelerate our mission to enable rapid diagnosis of infectious disease to improve patient outcomes. Together with Roche's diagnostics healthcare solutions, we will be able to provide a full suite of molecular diagnostic solutions to customers around the world,” said Scott Mendel, CEO of GenMark Diagnostics.  “We are thrilled to become a part of Roche and are confident that this is the right path forward for GenMark and our customers.” GenMark's Respiratory Pathogen Panels identify the most common viral and bacterial organisms associated with upper respiratory infection, including SARS-CoV-2, complementing Roche's extensive portfolio of COVID-19 diagnostics solutions. Terms of the Agreement Under the terms of the merger agreement, Roche will promptly commence a tender offer to acquire all of the outstanding shares of GenMark's common stock for US$ 24.05 per share in cash. Following the completion of the tender offer, Roche will acquire all remaining shares at the same price of US$ 24.05 per share in cash through a second step merger. The transaction is expected to close in the 2nd quarter of 2021 and is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of GenMark's common stock and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Citi is acting as financial advisor to Roche and Sidley Austin LLP is acting as legal counsel to Roche. J.P. Morgan Securities LLC is acting as exclusive financial advisor to GenMark and DLA Piper LLP is acting as legal counsel to GenMark. About GenMark Diagnostics GenMark Diagnostics is a leading provider of multiplex molecular diagnostic solutions designed to enhance patient care, improve key quality metrics and reduce the total cost-of-care. Utilizing GenMark's proprietary eSensor® detection technology, GenMark's eSensor XT-8® and ePlex® systems are designed to support a broad range of molecular diagnostic sample-to-answer tests with compact, easy-to-use workstations and self-contained, disposable test cartridges. GenMark's ePlex: The True Sample-to-Answer Solution™ is designed to optimize laboratory efficiency and address a broad range of infectious disease testing needs, including respiratory, bloodstream and gastrointestinal infections. 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 under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. 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. 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 twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals 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. IMPORTANT ADDITIONAL INFORMATION AND WHERE TO FIND IT THE TENDER OFFER FOR THE OUTSTANDING COMMON STOCK OF GENMARK DIAGNOSTICS HAS NOT BEEN COMMENCED. THIS ANNOUNCEMENT IS FOR INFORMATIONAL PURPOSES ONLY AND DOES NOT CONSTITUTE AN OFFER TO PURCHASE OR A SOLICITATION OF AN OFFER TO SELL GENMARK DIAGNOSTICS' COMMON STOCK. THE SOLICITATION AND OFFER TO BUY GENMARK DIAGNOSTICS' COMMON STOCK WILL ONLY BE MADE PURSUANT TO AN OFFER TO PURCHASE AND RELATED MATERIALS. AT THE TIME THE OFFER IS COMMENCED, ROCHE HOLDINGS, INC. (“ROCHE”) AND ITS ACQUISITION SUBSIDIARY, WILL FILE A TENDER OFFER STATEMENT ON SCHEDULE TO WITH THE SECURITIES AND EXCHANGE COMMISSION (THE “SEC”) AND THEREAFTER, GENMARK DIAGNOSTICS WILL FILE A SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 WITH RESPECT TO THE OFFER. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THESE MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) CAREFULLY WHEN THEY BECOME AVAILABLE SINCE THEY WILL CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND CONDITIONS OF THE OFFER. THE TENDER OFFER STATEMENT, SOLICITATION/RECOMMENDATION STATEMENT AND RELATED MATERIALS WILL BE FILED WITH THE SEC, AND INVESTORS AND SECURITY HOLDERS MAY OBTAIN A FREE COPY OF THESE MATERIALS (WHEN AVAILABLE) AND OTHER DOCUMENTS FILED BY ROCHE AND GENMARK DIAGNOSTICS WITH THE SEC AT THE WEBSITE MAINTAINED BY THE SEC AT WWW.SEC.GOV. INVESTORS AND SECURITY HOLDERS MAY ALSO OBTAIN FREE COPIES OF THE SOLICITATION/RECOMMENDATION STATEMENT AND OTHER DOCUMENTS FILED WITH THE SEC BY GENMARK DIAGNOSTICS AT WWW.GENMARKDX.COM. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS THIS ANNOUNCEMENT CONTAINS FORWARD-LOOKING STATEMENTS ABOUT GENMARK DIAGNOSTICS AS THAT TERM IS DEFINED IN SECTION 27A OF THE SECURITIES ACT OF 1933 AND SECTION 21E OF THE SECURITIES EXCHANGE ACT OF 1934. SOME OF THE STATEMENTS CONTAINED IN THIS ANNOUNCEMENT ARE FORWARD-LOOKING STATEMENTS, INCLUDING STATEMENTS REGARDING, AMONG OTHER THINGS, THE  EXPECTED CONSUMMATION OF THE TRANSACTION, THE CONDUCT OF GENMARK DIAGNOSTICS' PRINCIPAL OPERATIONS FOLLOWING SUCH CONSUMMATION, AND THE IMPACT OF GENMARK DIAGNOSTICS' SYNDROMIC PANEL TESTING PORTFOLIO ON ROCHE'S MOLECULAR DIAGNOSTICS PORTFOLIO, ALL OF WHICH INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES, INCLUDING, THE SATISFACTION OF CLOSING CONDITIONS FOR THE TRANSACTION, SUCH AS REGULATORY APPROVAL, THE TENDER OF A MAJORITY OF THE OUTSTANDING SHARES OF COMMON STOCK OF GENMARK DIAGNOSTICS, THE POSSIBILITY THAT THE TRANSACTION WILL NOT BE COMPLETED, AND OTHER RISKS AND UNCERTAINTIES DISCUSSED IN GENMARK DIAGNOSTICS' PUBLIC FILINGS WITH THE SEC, INCLUDING THE “RISK FACTORS” SECTION OF GENMARK DIAGNOSTICS' ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2020 AND SUBSEQUENT QUARTERLY REPORTS ON FORM 10-Q, AS WELL AS THE TENDER OFFER DOCUMENTS TO BE FILED BY ROCHE AND ITS ACQUISITION SUBSIDIARY AND THE SOLICITATION/RECOMMENDATION STATEMENT TO BE FILED BY GENMARK DIAGNOSTICS. THESE STATEMENTS ARE BASED ON CURRENT EXPECTATIONS, ASSUMPTIONS, ESTIMATES AND PROJECTIONS, AND INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES AND OTHER FACTORS THAT MAY CAUSE RESULTS, LEVELS OF ACTIVITY, PERFORMANCE OR ACHIEVEMENTS TO BE MATERIALLY DIFFERENT FROM ANY FUTURE STATEMENTS. THESE STATEMENTS ARE GENERALLY IDENTIFIED BY WORDS OR PHRASES SUCH AS “BELIEVE”, “ANTICIPATE”, “EXPECT”, “INTEND”, “PLAN”, “WILL”, “MAY”, “SHOULD”, “ESTIMATE”, “PREDICT”, “POTENTIAL”, “CONTINUE” OR THE NEGATIVE OF SUCH TERMS OR OTHER SIMILAR EXPRESSIONS. IF UNDERLYING ASSUMPTIONS PROVE INACCURATE OR UNKNOWN RISKS OR UNCERTAINTIES MATERIALIZE, ACTUAL RESULTS AND THE TIMING OF EVENTS MAY DIFFER MATERIALLY FROM THE RESULTS AND/OR TIMING DISCUSSED IN THE FORWARD- LOOKING STATEMENTS, AND YOU SHOULD NOT PLACE UNDUE RELIANCE ON THESE STATEMENTS. ROCHE AND GENMARK DIAGNOSTICS DISCLAIM ANY INTENT OR OBLIGATION TO UPDATE ANY FORWARD-LOOKING STATEMENTS AS A RESULT OF DEVELOPMENTS OCCURRING AFTER THE PERIOD COVERED BY THIS RELEASE OR OTHERWISE. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Roche signs definitive merger agreement with GenMark Diagnostics, Inc., to access novel technology to test for broad range of pathogens with one patient sample

Gilead Sciences

Roche's (RHHBY) Actemra in combination with Gilead's (GILD) Veklury did not meet the primary endpoint of improved time to hospital discharge for patients with severe COVID-19 pneumonia.

Roche (RHHBY) & Gilead's Drug Combo Study for COVID-19 Fails

Roche Holdings AG (OTCQX: RHHBY) has announced data from Phase 3 REMDACTA trial evaluating Actemra/RoActemra (tocilizumab) plus Gilead Sciences Inc's (NASDAQ: GILD) Veklury (remdesivir). The study did not meet the primary endpoint of improved time to hospital discharge up to day 28 in patients for Actemra + Veklury versus placebo plus Veklury.

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