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. (RHHBY) reports healthcare developments across medicines, diagnostics and digital health, including updates from Genentech as a member of the Roche Group. Recurring news covers operating and financial results, regional sales trends, product performance and regulatory disclosures tied to the company’s pharmaceutical and diagnostic portfolios.
Company updates frequently feature ophthalmology products and pipeline assets such as Vabysmo, Susvimo and vamikibart across retinal conditions including diabetic macular edema and neovascular age-related macular degeneration. Roche also reports clinical data in neurology and autoimmune disease, including fenebrutinib in multiple sclerosis and ENSPRYNG in myelin oligodendrocyte glycoprotein antibody-associated disease, along with diagnostics approvals and patient-education initiatives.
Roche (OTCQX: RHHBY) reported Phase III METEOROID results showing ENSPRYNG (satralizumab) reduced risk of new MOGAD relapse by 68% versus placebo (p=0.0025), meeting the primary endpoint. At 48 weeks, 87% on ENSPRYNG were relapse-free vs 67% on placebo; onset observed by 8 weeks.
Key secondary results: ARR down 66% (p=0.0030); MRI active lesions down 79% (p=0.0026); rescue therapy use down 73% (p=0.0024). Safety aligned with established ENSPRYNG profile; no new safety signals. Data will be submitted to regulators globally.
Genentech (OTCQX: RHHBY) said the FDA accepted its supplemental BLA for Gazyva for systemic lupus erythematosus (SLE), based on positive Phase III ALLEGORY data.
The study met the primary endpoint SRI-4 (76.7% vs 53.5%, adjusted difference 23.1%, 95% CI: 12.5-33.6, p<0.001) and showed higher remission (DORIS 33.8% vs 13.8%, adjusted difference 19.9%) and LLDAS (57.6% vs 25.0%). Safety was consistent with the known profile. The FDA decision is expected by December 2026.
Roche (OTCQX: RHHBY) said the FDA accepted its supplemental BLA for Gazyva/Gazyvaro (obinutuzumab) for systemic lupus erythematosus (SLE) based on positive phase III ALLEGORY results. The FDA decision is expected by December 2026.
ALLEGORY showed SRI-4 response 76.7% vs 53.5% (adjusted diff 23.1%, 95% CI 12.5-33.6, p<0.001). Secondary endpoints including remission and LLDAS also improved; safety was consistent with known profile and no new signals were identified.
Genentech (OTCQX: RHHBY) announced the FDA has accepted its supplemental BLA for Gazyva (obinutuzumab) to treat systemic lupus erythematosus (SLE) based on positive Phase III ALLEGORY results.
ALLEGORY showed 76.7% SRI-4 response with Gazyva versus 53.5% for placebo (adjusted difference 23.1%, 95% CI 12.5-33.6, p<0.001). FDA decision expected by December 2026; safety consistent with known profile.
Roche (OTCQX: RHHBY) announced on 13 April 2026 that its Elecsys Neurofilament Light Chain (NfL) blood test received CE mark for detecting neuroinflammation in adults with relapsing‑remitting multiple sclerosis (RRMS).
The minimally invasive test measures NfL to monitor neuroaxonal damage, runs on Roche cobas instruments, and aims to increase access to routine MS monitoring versus MRI-only approaches.
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 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) 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) 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.