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 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.
Roche reported a 9% increase in Group sales for 2021, reaching CHF 62.8 billion, driven by strong demand for newly launched medicines and diagnostics. The Pharmaceuticals Division saw a 3% sales growth, while the Diagnostics Division grew by 29%, largely due to COVID-19 tests. Key approvals included Susvimo and Vabysmo in the U.S. For 2022, Roche expects stable or low-single-digit sales growth, anticipating a decline in COVID-19 medicine sales by CHF 2 billion. Core EPS rose 6%, and the board proposed an increase in dividends to CHF 9.30.
Roche announced that William Pao, Head of Pharma Research and Early Development (pRED) since 2018, will leave the company effective 18 March 2022. He will be succeeded by Hans Clevers, a current board member, who will also join the Corporate Executive Committee. CEO Severin Schwan expressed confidence in Clevers' leadership, highlighting Pao's contributions to diversifying Roche's R&D portfolio. Hans Clevers, a notable figure in molecular genetics, brings extensive scientific expertise to his new role, suggesting a continued commitment to advancing personalized healthcare.
Roche announced the FDA's approval of Vabysmo (faricimab-svoa) for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), marking it as the first injectable eye medicine approved for both conditions. With the capability of administering injections every two to four months after initial treatment, Vabysmo targets Ang-2 and VEGF-A pathways linked to vision loss. Positive phase III study results indicated non-inferior vision gains compared to existing treatments, affirming its potential to reduce treatment burden for patients.