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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.
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Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC) Tecentriq® (atezolizumab). Tecentriq SC would be the first injectable PD-(L)1 cancer immunotherapy in the EU, potentially cutting treatment time by approximately 80%. The recommendation is based on pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation. The SC formulation is recommended for all indications in which Tecentriq IV has been previously approved, including certain types of lung, liver, bladder, and breast cancer. The subcutaneous administration offers a faster and more convenient alternative to IV infusion, potentially freeing up time for patients, healthcare teams, and caregivers. Tecentriq SC recently received its first marketing authorization in Great Britain and was developed to provide patients with an alternative to the IV administration of Tecentriq and the potential for treatment outside of the hospital setting. The CHMP's positive opinion brings Roche a step closer to offering the first subcutaneous PD-L1 cancer immunotherapy treatment to patients in the EU.
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Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that its Elecsys® Neurofilament Light Chain (NfL) test for Multiple Sclerosis (MS) received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The test aids in detection of disease activity in adults with MS, offering a minimally invasive testing option with the potential to provide patient insights for other neurological conditions. This supports better disease management decisions and addresses significant gaps in access to testing.
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Roche announces topline results from the Phase 3 EMBARK study of Elevidys in boys with Duchenne muscular dystrophy aged 4-7 years. Elevidys-treated patients showed improvement in motor function compared to placebo, with statistically significant treatment benefits observed in secondary functional endpoints. No new safety signals were observed. Further evaluation of data is ongoing.
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The FDA has approved Vabysmo for the treatment of macular edema following retinal vein occlusion. Vabysmo is the first and only bispecific antibody approved for the eye. The approval is based on positive results from Phase III studies showing early and sustained vision improvements. Vabysmo also demonstrated rapid and robust drying of retinal fluid. Safety results were consistent with previous trials.
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Roche's Vabysmo receives FDA approval for the treatment of macular edema following retinal vein occlusion (RVO). Vabysmo is now approved for three indications, including neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). The approval is based on positive results from phase III studies showing early and sustained vision improvements that were non-inferior to aflibercept, as well as rapid and robust drying of retinal fluid. The U.S. label update includes information on rare post-marketing reports of retinal vasculitis and/or retinal vascular occlusion, with a reporting rate in line with other intravitreal treatments.
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Roche collaborates with Ibex and Amazon Web Services to offer AI algorithms for breast and prostate cancer diagnosis through the navify Digital Pathology software platform. This collaboration aims to improve patient care and advance personalized healthcare.
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Roche has entered into an agreement to acquire Telavant Holdings, gaining the rights to develop and commercialize RVT-3101, a novel TL1A directed antibody for the treatment of inflammatory bowel disease and potentially other diseases. Roche will pay a purchase price of $7.1 billion upfront and a near-term milestone payment of $150 million. The acquisition includes an option to collaborate with Pfizer on a next-generation bispecific antibody.
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Roche Group reports 1% growth in sales at constant exchange rates in the first nine months of 2023, driven by strong performance in Pharmaceuticals Division. Positive development milestones include EU approval of Evrysdi for babies with spinal muscular atrophy and positive phase III data for Alecensa and Ocrevus.
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Roche announces that the Elecsys IL-6 immunoassay has received certification for use in diagnosing neonatal sepsis.
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Roche announces positive results from Phase III ALINA study in early-stage ALK-positive non-small cell lung cancer
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FAQ
What is the current stock price of ROCHE HOLDING S/ADR (RHHBY)?
The current stock price of ROCHE HOLDING S/ADR (RHHBY) is $34.96 as of December 24, 2024.
What is the market cap of ROCHE HOLDING S/ADR (RHHBY)?
The market cap of ROCHE HOLDING S/ADR (RHHBY) is approximately 235.1B.
What is Roche Holdings Ltd. S/ADR (RHHBY) known for?
Roche is a global leader in biotechnology, specializing in in-vitro diagnostics and the development of cutting-edge medicines.
What is the significance of Columvi® (glofitamab) in Roche's portfolio?
Columvi® (glofitamab) is the first CD20xCD3 bispecific antibody that has shown promising results in treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
How does Roche contribute to personalized healthcare?
Roche aims to transform healthcare delivery by focusing on scientific excellence, data insights, and partnerships with stakeholders to provide tailored treatment options for patients.
What recent innovation has Roche introduced in digital pathology?
Roche's VENTANA DP 200 whole-slide imaging system, with FDA clearance, allows pathologists to review and interpret digital pathology images efficiently, facilitating remote diagnosis and collaboration.
What is Roche's approach to advancing haematology treatments?
Roche has a robust portfolio and pipeline of haematology medicines, including T-cell engaging bispecific antibodies like Columvi®, to address the diverse needs of patients with blood cancers.
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