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, 13 October 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new long-term data that reinforce the benefit of early initiation and ongoing treatment of OCREVUS® (ocrelizumab) on disability progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS), as well as safety outcomes for an analysis of shorter 2-hour infusion in minority populations. OCREVUS data from all clinical trials consistently show a favourable benefit-risk profile over eight years. Roche and research partners will also present four late-breaking abstracts to share the latest data regarding COVID-19 and vaccine response in patients treated with OCREVUS. These data are being presented virtually at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). “Many neurologists have had first-hand experience with OCREVUS over eight years in clinical trials and witnessed the consistently favourable efficacy and safety outcomes in RMS and PPMS, especially the reductions in progression to disability when given early in the disease,” said Levi Garraway, M.D., Ph.D. Roche's Chief Medical Officer and Head of Global Product Development. “Additionally, the new safety analysis of the shorter two-hour OCREVUS infusion is encouraging particularly for groups that are often underrepresented in clinical trials. We continue our commitment to diversity and health equity in clinical trial participation and access to treatment.” Phase III OPERA I and OPERA II open-label extension (OLE): Sustained reduction in disability progression and low relapse rates in RMS Long-term OCREVUS treatment continues to demonstrate sustained reduction in disability progression and suppression of disease activity in people with RMS. Earlier intervention with OCREVUS resulted in a 35% reduction in the risk of patients with RMS needing a walking aid over seven and a half years compared with patients who switched from interferon beta-1a to OCREVUS after the 96-week double-blind period (5.2% vs 7.0%, respectively; 95% CI: 0.65 [0.44–0.97]; p=0.034). The risk was measured by the length of time until a person reached a score on the Expanded Disability Status Scale of 6 or greater (EDSS≥6) that was sustained for at least 48 weeks in a post-hoc analysis. Data also showed that switching from interferon beta-1a to OCREVUS at the start of the OLE period was associated with a rapid and robust reduction in annualised relapse rate (ARR) that was maintained through the 5.5-year OLE period. ARR was 0.2 pre-switch, 0.1 after 1 year of OCREVUS treatment and 0.03 after 5.5 years of OCREVUS treatment in the OLE. OCREVUS continuers maintained a low ARR of 0.03 after 7.5 years of OCREVUS treatment. Phase III ORATORIO OLE: Sustained reduction in overall and upper limb disability progression in PPMS After eight years, outcomes continue to favour early and ongoing treatment with OCREVUS to slow disability progression in people with PPMS. Earlier intervention with OCREVUS resulted in a 29% reduction in 48-week confirmed disability progression (CDP) in patients with PPMS over eight years compared with patients who switched to OCREVUS from placebo after the double-blind period of at least 120 weeks (95% CI: 0.71 [0.57–0.87]; p=0.001). A 24% (95% CI: 0.76 [0.62–0.92]; p=0.005) reduced risk of recurrent 48-week CDP (re-baselining EDSS after onset of CDP event) was seen in patients who were continuously treated with OCREVUS compared with those who switched from placebo. Many people with PPMS eventually transition into a wheelchair; therefore, maintaining the ability to use their hands and arms is important for these patients. Upper limb disability progression, measured by the nine-hole peg test (9-HPT), was also reduced in patients who were continuously treated with OCREVUS compared with those who switched from placebo (95% CI: 0.66 [0.50–0.86] respectively; p=0.002). OCREVUS long-term safety data consistent over 8 years New safety data as of November 2020 will be presented, representing 5,688 patients with RMS and PPMS and 21,675 patient-years of exposure to OCREVUS, across all OCREVUS clinical trials. These findings further demonstrate the consistently favourable benefit-risk profile of OCREVUS over eight years. Three shorter infusion studies: subgroup analysis in minority populations When treated with a shorter two-hour OCREVUS infusion, the rate and severity of infusion-related reactions in Black, African-American, Hispanic and Latino populations were similar to those reported in the overall patient population in a subgroup analysis of three studies (SaROD, CHORDS and ENSEMBLE PLUS). These patient populations may experience greater disease severity and faster progression, yet are vastly underrepresented in most clinical trials. A shorter infusion time may help reduce the burden on these patient populations and increase their access to treatment. Late-breaking abstracts: COVID-19 in patients treated with OCREVUS Patient safety is Roche's highest priority and we are closely monitoring the evolving COVID-19 situation. We are committed to working closely with the community to better understand the impact of COVID-19 on people who are treated with OCREVUS, and will continue to share new insights with the MS community as they emerge. Four late-breaking abstracts on COVID-19 in patients treated with OCREVUS, including vaccination response, will be presented by Roche and research partners. With rapidly growing real-world experience and more than 200,000 people treated globally, OCREVUS is the first and only therapy approved for relapsing MS (RMS; including RRMS and active, or relapsing, secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS] in the U.S.) and PPMS. At Roche, we are constantly striving to optimise the care for people with MS and a shorter two-hour OCREVUS infusion time, dosed twice yearly (six-monthly), is now approved for eligible people with RMS or PPMS in the U.S. and European Union (EU). OCREVUS is approved in 97 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland, the United Kingdom and the EU. About multiple sclerosis Multiple sclerosis (MS) is a chronic disease that affects more than 2.8 million people worldwide. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the central nervous system (brain, spinal cord and optic nerves), causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including muscle weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with MS experience their first symptom between 20 and 40 years of age, making the disease the leading cause of non-traumatic disability in younger adults. People with all forms of MS experience disease progression – permanent loss of nerve cells in the central nervous system and gradual worsening of disability – at the beginning of their disease even if their clinical symptoms aren't apparent or don't appear to be getting worse. Delays in diagnosis and treatment can negatively impact people with MS, both in terms of their physical, mental and financial health. An important goal of treating MS is to slow the progression of disability as early as possible. Relapsing-remitting MS (RRMS) is the most common form of the disease and is characterised by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Approximately 85% of people with MS are initially diagnosed with RRMS. The majority of people who are diagnosed with RRMS will eventually transition to secondary progressive MS (SPMS), in which they experience steadily worsening disability over time. Relapsing forms of MS (RMS) include people with RRMS and people with SPMS who continue to experience relapses. Primary progressive MS (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with MS are diagnosed with the primary progressive form of the disease. Until the FDA approval of OCREVUS, there had been no FDA-approved treatments for PPMS. About OCREVUS (ocrelizumab) OCREVUS is the first and only therapy approved for both RMS (including RRMS and active, or relapsing, SPMS and CIS in the U.S.) and PPMS, with six-month dosing. OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved. OCREVUS is administered by intravenous infusion every six months. The initial dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions. About Roche in neuroscience Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases. Roche is investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, Alzheimer's disease, Huntington's disease, Parkinson's disease, Duchenne muscular dystrophy and autism spectrum disorder. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today. 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, Roche 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 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. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Data up to 8-years for Roche's OCREVUS (ocrelizumab) show early and ongoing treatment significantly reduced risk of requiring a walking aid in relapsing multiple sclerosis and disability progression in primary progressive multiple sclerosis

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new long-term data that reinforce the benefit of early initiation and ongoing treatment of Ocrevus® (ocrelizumab) on disability progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS), as well as safety outcomes for an analysis of a shorter two-hour infusion in minority populations. Ocrevus data from all clinical trials consistently show

New Data up to 8-Years for Genentech's Ocrevus (ocrelizumab) Show Early and Ongoing Treatment Significantly Reduced Risk of Requiring a Walking Aid in Relapsing Multiple Sclerosis and Disability Progression in Primary Progressive Multiple Sclerosis

Roche (RHHBY) gets Breakthrough Therapy Designation for gantenerumab for Alzheime's disease, which puts the spotlight on this challenging but promising space.

Roche's (RHHBY) AD Drug Gets Breakthrough Therapy Status

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer's disease (AD). This designation is based on data showing that gantenerumab significantly reduced brain amyloid plaque, a patholo

Genentech's Anti-Amyloid Beta Antibody Gantenerumab Granted FDA Breakthrough Therapy Designation in Alzheimer's Disease

Roche Holdings AG's (OTC: RHHBY) gantenerumab antibody received breakthrough therapy designation from the FDA for Alzheimer's disease. Gantenerumab is designed to neutralize beta-amyloid plaques seen as a driver behind brain cell death.

Roche's Alzheimer's Candidate Secures FDA Breakthrough Designation

Basel, 8 October 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer's disease (AD). This designation is based on data showing that gantenerumab significantly reduced brain amyloid plaque, a pathological hallmark of AD, in the ongoing SCarlet RoAD and Marguerite RoAD open-label extension trials, as well as other studies. Learnings from these studies have been incorporated into the optimised design of two ongoing parallel, global, placebo-controlled and randomised Phase III trials, GRADUATE 1 and 2. The pivotal trials are evaluating gantenerumab in more than 2,000 participants for more than two years and are expected to be completed in the second half of 2022.

[Ad hoc announcement pursuant to Art. 53 LR] Roche's anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer's disease

Ad hoc announcement pursuant to Art. 53 LR: Genentech's Anti-Amyloid Beta Antibody Gantenerumab Granted FDA Breakthrough Therapy Designation in Alzheimer's Disease

Basel, 5 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new OCREVUS® (ocrelizumab) and ENSPRYNG® (satralizumab) data will be presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from 13 - 15 October 2021. These data include 38 abstracts highlighting new longer-term efficacy and safety for both OCREVUS and ENSPRYNG, as well as our ongoing efforts to evaluate the impact of the COVID-19 pandemic for people living with MS. Additional data will show how a deeper scientific understanding of MS and NMOSD in diverse patient populations could help ensure access to treatment. “The longer-term efficacy and safety data for both OCREVUS and ENSPRYNG reinforce the impact of these treatments - by significantly slowing disease progression in MS and by preventing debilitating relapses in NMOSD, respectively,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We continue to see that early and ongoing treatment markedly improves outcomes, and we'll continue to use scientific and real-world insights to improve our understanding and ways to support people living with these neurological disorders.” Multiple sclerosis (MS) Roche will present 27 MS studies, including long-term data that show earlier treatment with OCREVUS continues to impact disability progression up to 8 years in people with primary progressive multiple sclerosis (PPMS) and up to 7.5 years in people with relapsing multiple sclerosis (RMS) in the Phase III open label extension studies. Additionally, updated long-term safety analysis of all clinical trials in patients with RMS and PPMS will reinforce the consistently favourable benefit-risk profile of OCREVUS. Roche remains committed to addressing health disparities and we believe inclusive research can improve outcomes and derive insights that may address treatment barriers. A subgroup analysis of three studies (SaROD, CHORDS ENSEMBLE PLUS) in Black, African-American, Hispanic and Latino populations treated with a 2-hour OCREVUS infusion will be presented. Neuromyelitis optica spectrum disorder (NMOSD) New longer-term results from the SAkuraStar and SAkuraSky OLE studies for ENSPRYNG will show efficacy observed in the pivotal trials is sustained with high proportions of patients remaining free from relapse over four years of treatment. Similarly, safety data from the SAkuraStar and SAkuraSky OLE studies will show the favourable safety profile of ENSPRYNG is sustained with longer-term treatment. ENSPRYNG has been approved in 58 countries globally, including in the U.S. as the first and only subcutaneous treatment for adults with anti-aquaporin-4 antibody (AQP4-IgG) seropositive NMOSD. ENSPRYNG has also been approved for both adults and adolescents in the European Union, Japan, Canada and Switzerland. Roche is dedicated to increasing scientific understanding of NMOSD and improving care for all people living with the condition. The study design will be presented for SAkuraBONSAI, a prospective, open-label study of ENSPRYNG to generate data to further the understanding of the disease activity and mechanism of action of ENSPRYNG in patients living with AQP4-IgG seropositive NMOSD who are treatment naïve or where prior rituximab (or biosimilar) treatment has failed. Other presentations will examine the development of new tools and techniques to identify patients with NMOSD and assess disability better. Follow Roche on Twitter via @Roche and keep up to date with ECTRIMS 2021 news and updates by using the hashtag #ECTRIMS2021.

Roche to present new data on OCREVUS in multiple sclerosis and ENSPRYNG in neuromyelitis optica spectrum disorder at ECTRIMS 2021

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new Ocrevus® (ocrelizumab) and EnspryngTM (satralizumab-mwge) data will be presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from October 13 – 15, 2021. These data include 38 abstracts highlighting new longer-term efficacy and safety for both Ocrevus and Enspryng, as well as our ongoing efforts t

Genentech to Present New Data on Ocrevus (ocrelizumab) in Multiple Sclerosis and Enspryng (satralizumab-mwge) in Neuromyelitis Optica Spectrum Disorder at ECTRIMS 2021

Regeneron Pharmaceuticals

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Roche Holdings AG (OTC: RHHBY) announced positive data from Phase 2/3 2066 study of Ronapreve (casirivimab and imdevimab) or REGN-COV in hospitalized COVID-19 patients.  Related:   WHO Backs Regeneron COVID-19 Antibody Cocktail As It Calls For Equal Access.

Regeneron-Roche Post Encouraging New Data For COVID-19 Antibody Cocktail

Roche Holding AG said Thursday that its Phase 2/3 trial of Covid-19 treatment Ronapreve met its primary endpoint.

Roche says Phase 2/3 trial of COVID treatment Ronapreve met its primary endpoint

Basel, 30 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive data from the phase II/III 2066 study, investigating Ronapreve™ (casirivimab and imdevimab) in patients hospitalised with COVID-19. The trial met its primary endpoint, showing that Ronapreve significantly reduced viral load within seven days of treatment in patients who had not mounted a natural antibody response of their own (seronegative) and who required low-flow or no supplemental oxygen (p=0.0172). Full results of the study will be presented at ID Week 2021 today.

Phase II/III trial shows Ronapreve™ (casirivimab and imdevimab) significantly reduces viral load within seven days of treatment in patients hospitalised with COVID-19

Roche Holding AG (OTC: RHHBY) has highlighted new data for its oral spinal muscular atrophy (SMA) treatment Evrysdi, showing its benefits when given to pre-symptomatic babies with the rare disease. The data were presented at the World Muscle Society (WMS) Virtual Congress.

Roche Builds Case For Evrysdi Benefits In Younger Spinal Muscular Atrophy Patients

Basel, 24 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced data from across its growing neuromuscular portfolio at the World Muscle Society (WMS) Virtual Congress 20 – 24 September 2021. The presentations included additional results from the RAINBOWFISH study, evaluating the efficacy and safety of Evrysdi® (risdiplam) in babies with pre-symptomatic spinal muscular atrophy (SMA) from birth to six weeks of age and data supporting the continued clinical investigation of gene therapy, SRP-9001, in Duchenne muscular dystrophy (DMD). “These new data for Evrysdi may help extend the potential benefits of this medicine to the youngest SMA patients. Also, the data from SRP-9001 have helped to optimise the design of the upcoming Phase III trial for DMD,” said Levi Garraway, M.D., Ph.D, Roche's Chief Medical Officer and Head of Global Product Development. “Our goal is to continue to lead the way in developing transformative medicines for neuromuscular diseases. We are grateful for the partnerships that are helping us to develop new therapies for people impacted by these devastating rare diseases.” At WMS 2021, data from the ongoing open label RAINBOWFISH study were presented. Four out of five of those treated with Evrysdi for at least 12 months achieved standing and walking independently within the World Health Organization windows for healthy children. In addition, all five babies maintained the ability to swallow and were able to feed exclusively orally after 12 months of treatment. Previously reported results showed that babies treated with Evrysdi for at least 12 months achieved Hammersmith Infant Neurological Examination (HINE-2) motor milestones, with 100% (n=5) able to maintain head control, sitting upright, rolling and crawling. These data further add to the growing body of evidence supporting Evrysdi's efficacy in a broad patient population. More than 4,000 patients have been treated with Evrysdi in clinical trials, compassionate use, and real-world settings. In DMD, three-year data from the open-label trial, Study SRP-9001-101, evaluating the safety of a single dose of the investigational gene therapy SRP-9001 in four ambulatory children aged 4 and 7 years old with DMD, were presented. The study showed that SRP-9001 was well-tolerated with key functional assessment, measured by the North Star Ambulatory Assessment (NSAA), demonstrating an overall improvement in motor ability compared to baseline. The improvements in motor abilities were maintained over three years, signifying a durable response. The results support the continuation of clinical investigation to further assess the benefit/risk of SRP-9001 in patients with DMD. Roche, and partner Sarepta, also shared data from ENDEAVOR (Study SRP-9001-103), the first clinical trial using commercially representative SRP-9001 material for the treatment of DMD. Interim results from the first 11 participants in Cohort 1 (ambulatory boys aged 4-7 years) from the open label, ongoing Phase 1b study, provides evidence that SRP-9001 showed robust expression of micro-dystrophin and no new safety signals were identified. In addition, results from Part 1 of Study SRP-9001-102, an ongoing, randomised, double-blind, placebo-controlled clinical trial evaluating the safety, efficacy, and tolerability of a single dose of SRP-9001 in 41 boys with DMD, showed that the study met its primary biological endpoint of change in micro-dystrophin protein expression from baseline. Participants treated with SRP-9001, generally showed an increase in NSAA total score compared to placebo at 48 weeks, although this increase did not achieve statistical significance compared to that of patients who received placebo. The safety profile was consistent with prior studies, with no new safety signals identified. The results of these studies provide important information for SRP-9001's ongoing clinical development programme, with outcomes from Study 101 and 102 informing the design of the Phase 3 trial for SRP-9001, due to commence globally by the end of the year. About Evrysdi ® ( risdiplam ) Evrysdi is a survival of motor neuron 2 (SMN2) splicing modifier designed to treat SMA by increasing production of the survival of motor neuron (SMN) protein. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube. The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved Evrysdi for the treatment of SMA in adults and children 2 months of age and older. Evrysdi was granted PRIME designation by the EMA in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. At this time, Evrysdi has been approved in over 50 countries including the US and Europe and submitted in more than 30 countries. About SMA SMA is a severe, progressive neuromuscular disease that can be fatal. It affects approximately one in 10,000 babies and is the leading genetic cause of infant mortality. SMA is caused by a mutation of the survival motor neuron 1 (SMN1) gene, which leads to a deficiency of SMN protein. This protein is found throughout the body and is essential to the function of nerves that control muscles and movement. Without it, nerve cells cannot function correctly, leading to muscle weakness over time. Depending on the type of SMA, an individual's physical strength and their ability to walk, eat or breathe can be significantly diminished or lost. About SRP-9001 SRP-9001 (rAAVrh74.MHCK7.micro-dystrophin) is an investigational gene therapy designed to deliver the micro-dystrophin-encoding gene directly to the skeletal and cardiac muscle for the targeted production of the micro-dystrophin protein to enable a durable clinical response. Sarepta Therapeutics is responsible for global development and manufacturing for SRP-9001 and plans to commercialize SRP-9001 in the United States upon receiving FDA approval. In December 2019, Roche partnered with Sarepta to combine Roche's global reach, commercial presence, and regulatory expertise to accelerate access to SRP-9001 for patients outside the United States. About DMD DMD is a rare X-linked, progressive neuromuscular disease caused by mutations in the DMD gene that disrupts the production of functional dystrophin protein, leading to a loss of muscle function and premature death. DMD is one of the most common fatal genetic disorders, affecting approximately one in every 3,500 to 5,000 male births worldwide. Symptoms usually appear in infants and toddlers, with affected children presenting developmental delays such as difficulty walking, climbing stairs or standing from a sitting position. As DMD progresses, muscle weakness involves the arms, trunk, and other areas, meaning patients often require full-time use of a wheelchair in their early teens. Longevity is limited due to cardiac and/or respiratory failure. About Roche in Neuroscience Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Roche presents new data at World Muscle Society (WMS) 2021 highlighting new advances for people living with rare neuromuscular disorders

Basel, 22 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of three molecular PCR diagnostic test panels to simultaneously detect and differentiate common respiratory pathogens:

Roche launches three respiratory test panels on cobas 6800/8800 Systems in CE markets to help identify multiple pathogens with overlapping symptoms in patients

Roche (RHHBY) gets a positive CHMP opinion for Gavreto for the treatment of adult patients with RET fusion-positive advanced NSCLC.

Roche (RHHBY) Lung Cancer Drug Gets Positive CHMP Opinion

Basel, 20 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented new data from the Phase III IMpower010 study at the European Society for Medical Oncology (ESMO) Congress 2021 Presidential Symposium, reinforcing the significant disease-free survival (DFS) benefit offered by Tecentriq® (atezolizumab) for people with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%. Data from the IMpower010 trial were published simultaneously in The Lancet. In IMpower010, treatment with Tecentriq, following surgery and chemotherapy, reduced the risk of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88) in people with Stage II-IIIA NSCLC whose tumours express PD-L1≥1%, compared with best supportive care (BSC). Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified.

New Phase III data support the benefit of Roche's Tecentriq in early-stage lung cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today presented new data from the Phase III IMpower010 study at the European Society for Medical Oncology (ESMO) Congress 2021 Presidential Symposium, reinforcing the significant disease-free survival (DFS) benefit offered by Tecentriq® (atezolizumab) for people with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L1≥1%. Data from the IMpower010 trial were

New Phase III Data Support the Benefit of Genentech's Tecentriq in Early-stage Lung Cancer

Basel, 17 September 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 Gavreto® (pralsetinib) as a monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

Roche receives positive CHMP opinion for Gavreto® (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer

The ardor for shares of AC Immune SA ( ACIU , Financial) has cooled considerably since the company's Aug. 31 announcement of somewhat promising study results for its Alzheimer's drug. The Swiss biotech's stock shot up to a 52-week high of $12.61, but has since been halved as investors questioned how meaningful the trial results were.

Alzheimer's Drug for Roche Partner AC Immune Shows Promise

Basel, 15 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the introduction of the Roche Digital Pathology Open Environment that allows software developers to easily integrate their image analysis tools for tumour tissue with Roche's uPath enterprise software, an application for pathologist workflow. This open environment allows for the secure exchange and flow of data so that pathologists can access advanced algorithms from third parties alongside Roche's menu of artificial intelligence-based image analysis tools. This enables software developers globally to distribute their digital products through Roche's uPath software, offering a broader set of diagnostic tools for pathologists and ultimately the potential for better and faster answers for patients.

Roche opens access to pathology imaging tools to improve patient care

The stock price of Roche Holding's ADR reached its all-time high of $51 in August, before a recent sell-off in the stock, which led to a 3% drop in its price in five trading days to levels of $47 currently.

Will Roche Stock Rebound After A 7% Fall In A Week?

Novocure

Novocure Ltd (NASDAQ: NVCR) has entered into a clinical trial collaboration agreement with Roche Holdings AG (OTC: RHHBY) to develop Tumor Treating Fields (TTFields) together with Roche's atezolizumab in metastatic pancreatic ductal adenocarcinoma (mPDAC). The phase 2 study was designed to test the safety and efficacy of TTFields together with atezolizumab, gemcitabine, and nab-paclitaxel as a first-line treatment for mPDAC.

Novocure To Test Its Tumor Treating Fields With Roche's Tecentriq In Pancreatic Cancer

Roche Holdings AG (OTC: RHHBY) has agreed to acquire  TIB Molbiol Group for an undisclosed amount. The deal is expected to close in Q4 of 2021.

Roche Beefs Up PCR-Test Portfolio With TIB Molbiol Acquisition

Basel, 09 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has signed a definitive share purchase agreement to acquire 100% of the outstanding shares of the TIB Molbiol Group. Closing of the transaction is subject to customary conditions and is expected in the fourth quarter of 2021.

Roche signs definitive share purchase agreement with long-term partner TIB Molbiol to expand PCR-test portfolio in the fight against new infectious diseases

News for Roche Holding AG Stock (RHHBY)