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) reported Phase III ALLEGORY results showing Gazyva plus standard therapy met the primary endpoint in systemic lupus erythematosus (SLE).
At 52 weeks, 76.7% of Gazyva patients achieved SRI-4 versus 53.5% with placebo (adjusted difference 23.1%, 95% CI: 12.5–33.6; p<0.001). All five key secondary endpoints were met and safety aligned with the known profile.
Roche (OTCQX: RHHBY) announced NEJM publication of phase III ALLEGORY data showing Gazyva/Gazyvaro (obinutuzumab) plus standard therapy significantly reduced SLE disease activity at 52 weeks. Primary SRI-4 response was 76.7% vs 53.5% (adjusted difference 23.1%, 95% CI 12.5–33.6; p<0.001).
All five key secondary endpoints were met, including BICLA, sustained glucocorticoid reduction to ≤7.5 mg/day, SRI-6, longer time to first BILAG flare (HR 0.58, p=0.002) and higher DORIS remission (35.1% vs 13.8%). Safety was consistent with the known profile.
Roche (OTCQX: RHHBY) reported positive Phase II ZUPREME-1 topline results for petrelintide, an investigational once-weekly amylin analog for chronic weight management. In 493 participants (mean BMI 37 kg/m2), petrelintide produced up to 10.7% mean body weight loss at week 42 versus 1.7% with placebo (p<0.001) and showed placebo-like tolerability.
The maximally effective dose had no vomiting and no discontinuations for GI adverse events; 98% reached maintenance dose. Roche plans further development, ZUPREME-2 topline in H2 2026, and a combination trial in 2026.
Genentech (OTCQX:RHHBY) reported positive Phase II topline results for petrelintide, an once-weekly amylin analog for chronic weight management. The ZUPREME-1 trial (n=493, mean BMI 37 kg/m2) showed up to 10.7% mean weight reduction at week 42 versus 1.7% placebo (p<0.001) and placebo-like tolerability.
No vomiting occurred at the maximally effective dose; treatment discontinuations due to adverse events were 4.8% with petrelintide versus 4.9% with placebo. Full data will be presented at a medical congress; ZUPREME-2 topline is expected in H2 2026.
Roche (SIX: ROG) released a global survey of 4,326 people with diabetes across 22 countries on March 5, 2026, showing large day-to-day impacts from unpredictable glucose and a strong demand for predictive tools.
Key metrics: 80% would value predictive glucose tools; 61% report diabetes as a mental burden; 71% often feel tired. Roche will present related real-world evidence at ATTD on March 11, 2026.
Genentech (OTCQX: RHHBY) reported that Phase III FENhance 1 met its primary endpoint, showing fenebrutinib reduced annualized relapse rate by 51% versus teriflunomide over ≥96 weeks, consistent with FENhance 2 (-59%).
All three pivotal studies (including FENtrepid in PPMS) will be submitted to regulators and presented at AAN 2026. Safety notes: liver transaminase elevations were comparable; one Hy's Law case occurred in each arm; 8 fatal cases occurred in fenebrutinib arms versus 1 in teriflunomide, under further analysis.
Roche (OTCQX: RHHBY) reported that the pivotal Phase III study FENhance 1 met its primary endpoint, with investigational fenebrutinib reducing annualised relapse rate (ARR) by 51% versus teriflunomide over at least 96 weeks. This result aligns with FENhance 2 (59% ARR reduction).
Secondary endpoints showed significant reductions in brain lesions and favorable progression trends. Company plans to present full data at AAN 2026 and submit combined Phase III results, including FENtrepid in PPMS, to regulators. Safety signals include liver transaminase elevations comparable to teriflunomide and eight fatal cases in fenebrutinib arms under further analysis.
Genentech (OTCQX: RHHBY) said the FDA approved a combination of Venclexta (venetoclax) plus acalabrutinib for previously untreated adults with chronic lymphocytic leukemia (CLL), based on Phase III AMPLIFY results.
The all-oral, fixed-duration regimen reduced risk of progression or death by 35% (HR 0.65) versus chemoimmunotherapy; median follow-up was 42.6 months and median PFS was not reached for the combination. Safety was consistent with known profiles; common adverse reactions included neutropenia, headache, diarrhea, musculoskeletal pain, and COVID-19.
Genentech (OTCQX:RHHBY) announced FDA acceptance of the New Drug Application for giredestrant plus everolimus to treat ER-positive, HER2-negative, ESR1-mutated advanced breast cancer. The filing is supported by Phase III evERA results showing PFS benefit and a PDUFA date of December 18, 2026.
evERA reported PFS hazard ratios of 0.56 (ITT) and 0.38 (ESR1-mutated), with median PFS 8.77 and 9.99 months respectively; OS data remain immature but show positive trends.
Roche (OTCQX: RHHBY) announced FDA acceptance of its New Drug Application for giredestrant plus everolimus to treat adult patients with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer. The FDA set a PDUFA date of 18 December 2026.
Phase III evERA data showed PFS risk reductions of 44% (ITT) and 62% (ESR1-mutated), with median PFS 8.77 months (ITT) and 9.99 months (ESR1-mutated) versus ~5.5 months for comparators; OS data remain immature with positive trends.