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.
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.
Roche (OTCQX: RHHBY) announced Mark Dawson, M.D., Ph.D., will become Head of Roche Pharma Research and Early Development (pRED) and join the Enlarged Corporate Executive Committee, effective 1 May 2026.
Dawson joins from Peter MacCallum Cancer Centre, brings clinical and epigenetics expertise, multiple international honors, and academic appointments that position him to lead Roche pRED's next-generation therapy efforts.
Roche (OTCQX:RHHBY) announced that the phase III MAJESTY study in adults with primary membranous nephropathy met its primary endpoint, with significantly more patients achieving complete remission at 104 weeks with Gazyva/Gazyvaro versus tacrolimus.
Key secondary endpoints (overall remission at week 104 and complete remission at week 76) were also statistically significant. Safety was consistent with the known profile and no new safety signals were identified. Data will be presented at a medical meeting and shared with US and EU health authorities.
Genentech (NYSE:RHHBY) announced that the Phase III MAJESTY study in primary membranous nephropathy met its primary endpoint, with significantly more patients achieving complete remission at two years (104 weeks) with Gazyva versus tacrolimus. Safety was consistent with Gazyva's known profile and no new safety signals were identified.
Key secondary endpoints showed significant benefits in overall remission at week 104 and complete remission at week 76. Data will be shared with regulators and at a medical meeting.
Roche (OTCQX: RHHBY) reported Phase III FENtrepid results showing investigational oral BTK inhibitor fenebrutinib met the primary non-inferiority endpoint versus OCREVUS in primary progressive MS (PPMS).
Fenebrutinib reduced risk of 12-week confirmed disability progression by 12% (HR 0.88; 95% CI 0.75–1.03), showed a 26% benefit on upper limb function (9HPT), and plans regulatory submissions after the FENhance 1 readout expected mid‑first half 2026.
Roche (OTCQX: RHHBY) reported 2025 Group sales of CHF 61.5 billion, up 7% at constant exchange rates (2% in CHF). Core operating profit rose 13% to CHF 21.8 billion and core EPS increased 11% to CHF 19.46. IFRS net income was CHF 13.8 billion (+58% IFRS).
Key milestones: US and EU approval of subcutaneous Lunsumio, EU approval of Gazyva/Gazyvaro for lupus nephritis, multiple positive late‑stage trial readouts, 10 molecules advanced to phase III, CE marks for new diagnostic tests, and a proposed dividend of CHF 9.80 per share.
Genentech (OTCQX: RHHBY) reported positive Phase II topline results for CT-388, a once-weekly dual GLP-1/GIP receptor agonist for obesity. At the 24 mg dose, CT-388 produced a placebo-adjusted weight loss of 22.5% (efficacy estimand) and 18.3% (treatment‑regimen estimand) at 48 weeks, with a clear dose-response and no weight‑loss plateau. Responder rates at 48 weeks for 24 mg included 95.7% ≥5%, 87% ≥10%, 47.8% ≥20%, and 26.1% ≥30%. Among pre-diabetic participants, 73% normalized glucose vs 7.5% placebo. Safety was consistent with the incretin class; discontinuations for adverse events were 5.9% in CT-388 arms vs 1.3% placebo. Phase III (Enith1/Enith2) is expected to start this quarter.
Roche (OTCQX: RHHBY) reported positive Phase II topline results for CT-388, a once-weekly dual GLP-1/GIP agonist for obesity. At the highest tested dose (24 mg) CT-388 achieved a placebo-adjusted weight loss of 22.5% (efficacy estimand) and 18.3% (treatment-regimen estimand) at 48 weeks, with a clear dose-response and no weight-loss plateau. At 24 mg, 95.7% lost ≥5%, 87% lost ≥10%, 47.8% lost ≥20%, and 26.1% lost ≥30% at week 48. 73% of pre-diabetic participants normalized blood glucose versus 7.5% for placebo. Safety was consistent with the incretin class; discontinuations for AEs were 6%. Phase III programme (Enith1/Enith2) is expected to start this quarter.