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Roche Holdings Ltd. S/ADR (RHHBY) is a leading biotechnology company with a global presence in the field of in-vitro diagnostics. Roche focuses on scientific excellence to develop medicines and diagnostics for improving and saving lives. The company's pivotal role in personalized healthcare is reflected in its commitment to transforming healthcare delivery. Roche's innovative approach encompasses the discovery and development of cutting-edge treatments, including the first CD20xCD3 bispecific antibody, Columvi® (glofitamab), for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The company's recently FDA-cleared whole-slide imaging system, VENTANA DP 200, signifies Roche's dedication to revolutionizing pathology workflows through digitalization and artificial intelligence-based tools, ensuring pathologists can provide accurate and timely diagnoses. Roche's extensive portfolio and pipeline of haematology medicines demonstrate its unwavering commitment to advancing treatment options for patients worldwide.
Roche has collaborated with Bristol Myers Squibb to enhance personalised healthcare through digital pathology. The partnership focuses on the development of two AI-driven assays aimed at improving clinical trial processes for solid tumor treatment. One algorithm will assist in interpreting the VENTANA PD-L1 Assay, while the second will integrate CD8 biomarker analysis into Roche's NAVIFY Digital Pathology software. This initiative aims to boost cancer diagnosis accuracy and patient treatment options.
Roche (OTCQX: RHHBY) has announced a significant donation of medical supplies to Ukraine, delivering an additional 4,600 packs of specialized medicines alongside 150,000 packs of antibiotics. These new provisions include treatments for influenza, rheumatoid arthritis, spinal muscular atrophy, and various cancers, plus reagents for 120,000 blood tests and diabetes management support. Roche emphasizes its commitment to addressing healthcare needs in Ukraine while condemning the invasion and striving to maintain global supply chains for its products.
Roche, through its subsidiary TIB Molbiol, announced the availability of research tests identifying SARS-CoV-2 variants, including Omicron subvariants BA.1, BA.1.1, BA.2, BA.2.2, BA.3, and Delta. The WHO has noted an increase in the prevalence of the BA.2 subvariant, particularly in Denmark. Roche's tests are designed to monitor the spread of variants and inform public health responses, aiding the ongoing development of vaccines and therapeutics. These research tests complement Roche's existing SARS-CoV-2 diagnostic solutions, underscoring Roche's commitment to addressing the COVID-19 pandemic.
Roche announced new three-year efficacy data for Evrysdi (risdiplam) in spinal muscular atrophy (SMA), confirming sustained motor function improvements in patients aged 2-25 years from the SUNFISH study.
Additionally, interim results from RAINBOWFISH showed that most babies treated with Evrysdi for at least a year were able to stand and walk within typical developmental timelines. Over 5,000 patients have received Evrysdi in various settings, demonstrating its broad application and safety profile, with adverse events decreasing over time.
Roche's Annual General Meeting (AGM) held on March 15, 2022, approved all Board of Directors' proposals, including the re-election of Christoph Franz as Chairman with 98.91% support. Notably, the dividend was raised for the 35th consecutive time to CHF 9.30 per share. Shareholders also confirmed the remuneration packages for the Corporate Executive Committee and the Board. New Board member Jemilah Mahmood was elected, and the independent proxy Testaris AG represented 77.25% of total shares. Roche continues to make significant advancements in diagnostics and therapeutics amid the ongoing pandemic.
Roche has announced new data on Evrysdi® (risdiplam) for spinal muscular atrophy (SMA) and gene therapy for Duchenne muscular dystrophy (DMD) ahead of the MDA Conference from March 13-16, 2022. Interim results from the RAINBOWFISH study indicate that most infants treated with Evrysdi for at least 12 months achieved milestones such as sitting, standing, and walking. Roche, alongside Sarepta, is also reporting promising early-stage gene therapy results for DMD, supporting progression into the pivotal Phase III EMBARK study.
On March 2, 2022, Roche announced a donation of 150,000 packages of Rocephin, an essential antibiotic, to Ukraine amidst the ongoing conflict. Roche condemns the invasion and emphasizes its commitment to support the Ukrainian people through medical products. The medicines will be delivered promptly, with the company coordinating efforts with external partners despite logistical challenges. Roche aims to ensure consistent supply of critical medicines, diagnostics, and ongoing clinical trial access for displaced Ukrainian patients.
Roche announced the expansion of its COVID-19 PCR portfolio with the cobasⓇ 5800 System, recently launched in CE-mark-accepting countries. This new system includes the cobas SARS-CoV-2 Qualitative and cobas SARS-CoV-2 & Influenza A/B tests, enhancing Roche's molecular diagnostics capabilities. The compact design of the cobas 5800 System increases access to testing in resource-limited settings, optimizing performance for various laboratory sizes. Roche also aims for further menu expansions on this system throughout 2022.
Roche announced that its drug Actemra®/RoActemra® received prequalification from the World Health Organization (WHO), confirming its standards for treating severe COVID-19. Over one million patients have been treated globally, as per guidelines. This marks Roche's twelfth medicine or test to achieve such prequalification. The company aims to enhance access to Actemra/RoActemra for low- and middle-income countries, collaborating with WHO to provide the drug at cost and ensuring legal certainty for manufacturers. Roche has also enabled over 1.2 billion COVID-19 tests since the pandemic began.
Roche announced new two-year data from phase III studies of Vabysmo and Susvimo, showing significant advancements in treatment for diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). In the YOSEMITE and RHINE studies, at least 60% of eligible patients could extend Vabysmo treatments to every four months, up from 50% at year one. Nearly 80% could extend to three months or longer. The Archway study revealed that 95% of Susvimo patients maintained a six-month treatment schedule. Both therapies demonstrate improved vision outcomes and favorable safety profiles.
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