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.
Genentech (OTCQX: RHHBY) launched the All Eyes on DME public-awareness campaign on April 24, 2026, partnering with advocacy group diaTribe and comedian Damon Wayans to raise awareness of diabetic macular edema (DME).
The campaign highlights that 750,000 people in the U.S. live with DME, people of color face 2–3x higher risk, and about 60% of Americans with diabetes miss annual eye exams.
Roche (OTCQX: RHHBY) reported Group sales of CHF 14.7bn in Q1 2026: +6% at constant exchange rates, -5% in CHF and +9% in USD. Pharmaceuticals grew +7% CER (CHF 11.5bn) and Diagnostics +3% CER (CHF 3.3bn). Key clinical wins include positive phase III results for fenebrutinib (MS) and Gazyva (membranous nephropathy), CE mark for Elecsys NfL, launch of an NVIDIA AI factory, a definitive agreement to acquire SAGA Diagnostics, and a dividend increase to CHF 9.80. Outlook: mid single‑digit Group sales growth (CER) and high single‑digit core EPS growth (CER) for 2026.
Roche (OTCQX: RHHBY) reported that investigational fenebrutinib met primary endpoints in Phase III FENhance 1 and 2 in relapsing multiple sclerosis (RMS), cutting annualised relapse rates by 51.1% and 58.5% versus teriflunomide over 96 weeks.
Fenebrutinib also markedly reduced new T1-Gd+ and T2 brain lesions and showed positive trends on disability; total Phase III data will be submitted to regulators.
Genentech (OTCQX: RHHBY) reported positive Phase III FENhance 1 and 2 results for investigational fenebrutinib in relapsing multiple sclerosis (RMS). Fenebrutinib reduced annualized relapse rate by 51.1% and 58.5% versus teriflunomide over 96 weeks and cut new brain lesions markedly.
Secondary endpoints showed large MRI reductions and trends toward less confirmed disability progression; total RMS and PPMS data will be submitted to regulators.
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) reported Phase III METEOROID results showing Enspryng (satralizumab) reduced risk of MOGAD relapse by 68% versus placebo (p=0.0025) and achieved 87% relapse-free at 48 weeks versus 67% for placebo. Key secondary endpoints (ARR, MRI lesions, rescue therapy) were also significantly improved. Data will be submitted to regulators globally; no new safety signals reported.
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.
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) 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.