Welcome to our dedicated page for Roche Hldg news (Ticker: RHHBY), a resource for investors and traders seeking the latest updates and insights on Roche Hldg stock.
Roche Holding Ltd/ADR (RHHBY) is linked to a stream of news that reflects the company’s activities in biotechnology, pharmaceuticals and diagnostics. Recent announcements from Roche and its U.S. affiliate Genentech highlight regulatory approvals, late‑stage clinical trial results, new diagnostic platforms and agreements related to access and manufacturing.
Investors and healthcare observers following RHHBY news will see updates on oncology and haematology programmes, such as the U.S. Food and Drug Administration’s accelerated approval of Lunsumio VELO, a subcutaneous CD20xCD3 bispecific antibody for relapsed or refractory follicular lymphoma after at least two prior lines of systemic therapy. News also covers Phase III data for the investigational oral SERD giredestrant in ER‑positive early‑stage breast cancer, as well as new data on Lunsumio combinations and long‑term outcomes in lymphomas presented at major scientific meetings.
On the diagnostics side, Roche has reported the U.S. launch of next‑generation cobas 6800/8800 systems and software upgrades, CE Mark approval for its cobas Mass Spec solution reagent pack for antibiotics drug monitoring, and CE Mark for the cobas BV/CV assay for bacterial vaginosis and candida vaginitis. These stories illustrate how the company is expanding its in‑vitro diagnostic menu and enhancing laboratory efficiency.
Additional news items include European Commission approval of Gazyva/Gazyvaro for lupus nephritis and Genentech’s agreement with the U.S. government addressing prescription drug costs and direct‑to‑patient programmes. For users of this page, the RHHBY news feed offers a central place to review such regulatory milestones, clinical trial readouts, product launches and policy‑related developments associated with Roche and the Roche Group.
Roche has announced groundbreaking results from the Phase III IMbrave050 study, showing that the combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) significantly reduced the risk of disease recurrence in patients with hepatocellular carcinoma (HCC) following surgery. Specifically, the combination therapy resulted in a 28% reduction in recurrence risk compared to active surveillance, demonstrating its efficacy in high-risk patients. With up to 80% of HCC patients experiencing recurrence post-surgery, these results herald a potential shift in treatment standards. The findings will be presented at the AACR Annual Meeting 2023, with ongoing discussions with health authorities about future steps.
Roche (OTCQX: RHHBY) announced new data for Vabysmo at the 2023 ARVO Annual Meeting, showcasing promising results in treating neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Key findings indicate that Vabysmo promotes rapid fluid drying compared to aflibercept, enhancing visual acuity while allowing extended treatment intervals early in therapy. Real-world studies suggest most patients can extend dosing intervals while maintaining vision. Additionally, Roche will present initial phase I data on an investigational anti-IL-6 treatment, which may improve outcomes for patients with uveitic macular edema (UME). The company remains dedicated to advancing therapies for vision-threatening retinal conditions.
Roche has announced a collaboration with Eli Lilly to advance the development of its Elecsys Amyloid Plasma Panel (EAPP), which aims to facilitate earlier Alzheimer’s disease diagnosis. Currently, about 75% of symptomatic individuals remain undiagnosed for an average of 2.8 years. The collaboration aims to improve diagnosis accuracy and access to treatments. The EAPP has received Breakthrough Device Designation from the FDA and will help identify patients unlikely to have amyloid pathology, expediting further evaluations. The global dementia population is expected to rise from 55 million to nearly 140 million by 2050, underscoring this initiative's importance.
Roche (OTCQX: RHHBY) announced long-term data from the pivotal SUNFISH study for Evrysdi® (risdiplam), showing sustained increases in motor function in individuals aged 2-25 with Type 2 and non-ambulant Type 3 spinal muscular atrophy (SMA) over four years. The overall rate of adverse events decreased during this period. More than 8,500 patients have been treated with Evrysdi, which is approved in over 90 countries. The data, presented at the MDA Clinical Conference, reinforces Evrysdi's long-term efficacy and safety profile, indicating its significant impact on daily living activities for SMA patients.
On March 14, 2023, Roche (OTCQX: RHHBY) held its Annual General Meeting, where all proposals by the Board of Directors were approved, including the election of Severin Schwan as the new Chairman. Thomas Schinecker was appointed as the new CEO. Shareholders approved a dividend increase to CHF 9.50 per share, marking the 36th consecutive rise. The meeting also ratified the actions of the Board and authorized future remuneration for its members. KPMG AG was appointed as the external auditor for 2023. The company continues to focus on enhancing healthcare outcomes through innovative diagnostics and pharmaceuticals.
The U.S. FDA’s Oncologic Drugs Advisory Committee voted 11 to 2 in favor of Roche's Polivy (polatuzumab vedotin-piiq) combined with R-CHP for treating previously untreated diffuse large B-cell lymphoma (DLBCL). This marks the first groundbreaking treatment in two decades, showing significant improvement in progression-free survival against the standard R-CHOP. The FDA is expected to decide on the supplemental application by April 2, 2023. DLBCL, the most prevalent form of non-Hodgkin lymphoma, has seen limited advancements in treatment outcomes. Polivy's combination therapy was also recognized as a preferred option in NCCN Clinical Practice Guidelines.
Genentech, part of the Roche Group, received an 11 to 2 vote from the FDA’s Oncologic Drugs Advisory Committee in favor of Polivy (polatuzumab vedotin-piiq) combined with R-CHP for treating untreated diffuse large B-cell lymphoma (DLBCL). This marks the first treatment in 20 years to show significant improvement in progression-free survival over standard therapy. The FDA will decide on the supplemental Biologics License Application by April 2, 2023. Polivy has already been approved in over 60 countries for DLBCL. With findings indicating a 27% reduction in disease progression compared to R-CHOP, this treatment offers new hope for DLBCL patients.
Roche announces FDA approval for the VENTANA PD-L1 (SP263) Assay, enabling identification of non-small cell lung cancer (NSCLC) patients eligible for Libtayo treatment. This approval expands access to immunotherapy for patients with locally advanced and metastatic NSCLC, a group comprising over 60% of NSCLC diagnoses.
The assay is vital for guiding clinical decisions and optimizing patient outcomes. It is uniquely positioned as the only FDA-approved product for NSCLC across four immunotherapy options, aimed at improving treatment pathways for lung cancer, which remains the leading cause of cancer death worldwide.
Roche has received FDA approval for the VENTANA PD-L1 (SP263) Assay, enhancing access to Libtayo (cemiplimab) for patients with non-small cell lung cancer (NSCLC). This assay identifies those eligible for treatment, expanding options for over 60% of diagnosed NSCLC patients at advanced stages. This advancement is crucial as lung cancer remains the top cause of cancer deaths globally, with over 2.2 million diagnoses annually.
The VENTANA assay is unique, providing indications for four different immunotherapies, and underpins the importance of personalized medicine in improving patient outcomes.
Roche has expanded its collaboration with the U.S. Centers for Disease Control and Prevention (CDC) to enhance laboratory capabilities in regions severely impacted by HIV and tuberculosis. This initiative, known as Lab Networks for Health, aims to improve detection, prevention, and treatment outcomes in selected African, Eastern European, and Central Asian countries. The partnership will focus on workforce development, quality management systems, and multi-pathogen testing. With approximately 2 billion people infected with tuberculosis and over 38 million living with HIV, strengthening laboratory networks is essential for public health.