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 FDA approval for FoundationOne CDx as a companion diagnostic for Rozlytrek, enhancing treatment for ROS1 fusion-positive non-small cell lung cancer and NTRK fusion-positive solid tumors. FoundationOne CDx is the first FDA-approved test of its kind, leveraging comprehensive genomic profiling to personalize cancer therapy. The initiative represents a key milestone in developing tumor-agnostic cancer treatments, supported by Roche's leadership in diagnostic tools and drug development.
On June 9, 2022, Roche received approval from the European Commission for Tecentriq (atezolizumab) as an adjuvant treatment for adults with high-risk non-small cell lung cancer (NSCLC) following surgery and chemotherapy. This approval marks Tecentriq as the first cancer immunotherapy approved in Europe for early-stage NSCLC. In the Phase III IMpower010 trial, Tecentriq demonstrated a 57% reduction in the risk of disease recurrence or death, making it a significant advancement in lung cancer treatment. Roche plans further studies to analyze overall survival data.
The European Commission has granted conditional marketing authorization for Lunsumio® (mosunetuzumab), a bispecific antibody for treating adult patients with relapsed or refractory follicular lymphoma (FL). Based on the phase I/II GO29781 study, Lunsumio showed a 60% complete response rate and an 80% objective response rate, with the majority of responses lasting at least 18 months. This treatment is a chemotherapy-free, off-the-shelf option, potentially transforming FL management. Over 28,000 new FL cases are diagnosed annually in Europe.
Roche has received FDA approval for a label extension of Evrysdi (risdiplam) to treat spinal muscular atrophy (SMA) in babies under two months. This decision is based on positive interim results from the RAINBOWFISH study, showing that most pre-symptomatic infants treated for a year achieved significant motor milestones, such as sitting, standing, and walking. Additionally, updated prescribing information reflects promising data from the FIREFISH study, indicating that symptomatic infants treated for two years can also meet key motor milestones.
Roche (OTCQX: RHHBY) announced pivotal data from the NP30179 expansion study of glofitamab at ASCO and EHA 2022, showing a 39.4% complete response rate in patients with heavily pre-treated diffuse large B-cell lymphoma (DLBCL) after a median follow-up of 12.6 months. Glofitamab offers a fixed-duration treatment approach, with 77.6% of responses being durable at 12 months. The drug is part of Roche's bispecific antibody development program, aimed at enhancing treatment for blood cancers. Submissions for regulatory approval to the EMA and FDA are planned this year.
Genentech announced new pivotal data on its investigational CD20xCD3 bispecific antibody, glofitamab, to be presented at ASCO and EHA 2022. Following a median 12.6-months follow-up, 39.4% of heavily pre-treated patients with diffuse large B-cell lymphoma (DLBCL) achieved a durable complete response, with 51.6% showing overall response. Glofitamab, given as a fixed-duration treatment, may improve outcomes for patients facing limited options. Regulatory submissions are being planned to EMA and FDA for approval.
Roche has received European Commission approval for Polivy (polatuzumab vedotin) in combination with R-CHP for treating previously untreated diffuse large B-cell lymphoma (DLBCL). This first new treatment in over 20 years demonstrates a significant improvement in progression-free survival over the standard R-CHOP regimen, with a 27% reduction in disease progression risk. The approval was grounded in the pivotal POLARIX study results, showing comparable safety profiles. Roche aims to alleviate DLBCL burdens on patients and healthcare systems.
Roche and its subsidiary TIB Molbiol have launched three LightMix® Modular Virus kits designed for the detection of the monkeypox virus amid rising cases in non-endemic countries. The kits will aid in assessing the spread of the virus and support public health measures. The first kit detects orthopoxviruses, while the second targets only monkeypox viruses. A third kit simultaneously identifies both, enhancing research capabilities. These test kits will be available for research use globally.
Roche (OTCQX: RHHBY) announced significant findings to be presented at the 2022 ASCO Annual Meeting, focusing on innovative cancer treatments. Key highlights include data on glofitamab, a bispecific antibody designed for aggressive lymphoma, and its phase II trial results. Further presentations will cover genomic testing in cancer treatment, as well as updates on various oncology therapies, showcasing Roche's commitment to advancing personalized cancer care and improving patient outcomes.
Roche (OTCQX: RHHBY) has partnered with The Global Fund to enhance diagnostic capabilities in low- and middle-income countries (LMICs), targeting infectious diseases like tuberculosis (TB) and HIV. The collaboration aims to improve access to diagnostics, helping millions of undiagnosed individuals. Currently, about 2 billion people are estimated to have TB, with a significant portion of TB fatalities occurring in LMICs. The COVID-19 pandemic has further disrupted healthcare programs, intensifying the need for immediate action in diagnostics to save lives.