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 (OTCQX: RHHBY) launched the cobas MPX-E assay on 30 March 2026, a 4-in-1 qualitative NAT donor screening test for HIV-1/2, HCV, HBV, and HEV now available in countries accepting the CE mark.
Designed for fully automated cobas x800 systems, the assay enables high-throughput screening with up to 8 hours walk-away time, dual-target HIV-1 detection, and allows HEV screening without extra instrumentation. Roche cites an ~800m CHF global NAT blood-screening market with ~+2% CAGR (2024–2029).
Roche (OTCQX: RHHBY) launched the cobas eplex respiratory pathogen panel 3 (RP3), a diagnostic test now available in countries accepting the CE mark. The RP3 detects up to 250 viruses and bacteria, including SARS-CoV-2, influenza, Bordetella pertussis and RSV, from a single patient sample.
The test requires <1 minute hands-on time, runs on the cobas eplex system, and aims to speed diagnosis, guide targeted treatment, and help hospitals manage surge capacity and isolation beds.
Roche (OTCQX: RHHBY) launched the cobas eplex respiratory pathogen panel 3 (RP3), a multiplex diagnostic now available in countries accepting the CE mark that detects up to 25 viruses and bacteria from a single sample.
The test targets pathogens including SARS-CoV-2, influenza, Bordetella pertussis, and RSV, requires less than one minute hands-on time, and is designed for 24/7 use on the cobas eplex system to aid rapid clinical decisions and hospital surge management.
Roche (OTCQX: RHHBY) inaugurated a new research home for the Institute of Human Biology on 23 March 2026, part of a CHF 1.4 billion site investment in Basel & Kaiseraugst.
Building 92 houses up to 250 researchers, focuses on human organoids, organ-on-chip and AI-driven in silico models, and reinforces Roche's multi-year Swiss R&D investments totaling around CHF 41 billion (2016–2025).
Roche (OTCQX: RHHBY) announced on March 18, 2026 that the FDA has classified its Ionify steroid assays as CLIA "moderate complexity," expanding routine clinical access to mass spectrometry testing. The assays (Estradiol, DHEA, DHEA-S, Progesterone, 17-Hydroxyprogesterone, Androstenedione) run on the cobas i 601 analyzer.
The designation follows Roche's earlier Ionify 25-Hydroxy Vitamin D Total approval and aims to standardize and automate mass spec workflows, reducing lab variability and enabling wider clinical adoption while Roche continues regulatory review of additional assays.
Roche (OTCQX: RHHBY) launched a large-scale hybrid-cloud NVIDIA AI factory on 16 March 2026, adding 2,176 Blackwell GPUs to reach a total exceeding 3,500 GPUs across on-premise and cloud infrastructure.
The platform embeds AI across R&D, manufacturing, diagnostics and digital health, supporting Lab-in-the-Loop, digital twins, accelerated genomic and pathology analysis, and conversational healthcare AI to speed drug and diagnostic development.
Roche (RHHBY) received CE mark on March 16, 2026 for the Elecsys ApoE4 blood-based IVD immunoassay, the first CE-marked test to identify ApoE4 carriers from a simple blood sample. The test screens carriers vs non-carriers, reducing the need for broad DNA testing and supporting DMT decisions.
The assay integrates with existing Roche instruments in CE-mark countries, offering a scalable plasma-based solution to triage patients with cognitive decline.
Roche (OTCQX: RHHBY) shareholders approved all Board proposals at the 10 March 2026 Annual General Meeting. Key outcomes: re-election of Severin Schwan as Chairman, 39th consecutive dividend increase to CHF 9.80 per share, approval to exchange Genussscheine for Participation Certificates (ticker ROP), and reduction of nominal share value to CHF 0.001.
Shareholders representing 77.22% of shares attended; key votes passed with high majorities, and KPMG AG was appointed statutory auditor for 2026.
Genentech (OTCQX: RHHBY) announced Phase III persevERA results in ER-positive, HER2-negative advanced breast cancer on March 9, 2026. The study did not meet its primary endpoint of a statistically significant progression-free survival benefit for giredestrant plus palbociclib versus letrozole plus palbociclib, though a numerical improvement was observed.
Adverse events were manageable and consistent with known safety profiles. Genentech cites positive evERA and lidERA readouts, FDA acceptance of an NDA based on evERA, and plans to submit lidERA data to the FDA in the coming weeks.
Roche (OTCQX: RHHBY) reported that the phase III persevERA study of giredestrant plus palbociclib in 1L ER+/HER2- advanced breast cancer did not meet its primary endpoint of a statistically significant improvement in progression-free survival, though a numerical improvement was observed.
Safety was manageable and consistent with known profiles. The FDA accepted a giredestrant NDA based on evERA data; lidERA phase III data will be submitted to the FDA in the coming weeks. Full persevERA results will be presented at a medical meeting; pionERA is expected to read out in 2027.