While Roche’s persevERA trial didn’t meet its primary endpoint, the pharmaceutical company remains committed to advancing giredestrant as a new standard-of-care endocrine therapy. The FDA has accepted the company’s New Drug Application based on positive evERA data, signaling promise for this ER-positive breast cancer treatment.
Roche’s Phase III ALLEGORY trial reveals that Gazyva plus standard therapy helped 76.7% of SLE patients achieve significant clinical improvement. New data published in NEJM highlights Gazyva’s potential to redefine the standard of care in lupus by preventing organ damage and reducing steroid dependency.
Roche’s investigational amylin analog, petrelintide, achieved a statistically significant 10.7% mean body weight reduction in a Phase II trial, offering a well-tolerated alternative to current obesity treatments.
In a landmark announcement, Roche revealed that Gazyva (obinutuzumab) met its primary endpoint in the phase III MAJESTY trial for primary membranous nephropathy treatment. The trial data demonstrates superior clinical outcomes compared to tacrolimus, positioning Gazyva as a transformative therapy for patients with this chronic autoimmune kidney condition. With nearly 88,000 affected patients in the EU and over 96,000 in the US, primary membranous nephropathy represents a significant unmet medical need. Gazyva phase III results show the potential to become the first FDA and EMA-approved therapy specifically for this indication. The positive MAJESTY trial outcomes highlight Gazyva’s mechanism deep tissue B cell depletion via anti-CD20 targeting as an effective approach to halting disease progression and preserving kidney function in primary membranous nephropathy patients.
Roche has announced robust 2025 results, reporting a 7% increase in Group sales (CER) and a massive 58% jump in IFRS net income. With 12 positive late-stage clinical readouts—including the promising obesity candidate CT-388—and a bullish 2026 forecast, the Swiss healthcare giant proves its resilience despite significant currency headwinds.
Roche has unveiled breakthrough Phase II data for its obesity candidate, CT-388, showing a 22.5% reduction in body weight over 48 weeks. With nearly 73% of pre-diabetic patients returning to normal glucose levels, Roche is fast-tracking the drug into Phase III Enith trials to challenge the metabolic health market.
The FDA has granted accelerated approval to Roche’s Lunsumio VELO™, a revolutionary subcutaneous formulation for adult patients with relapsed or refractory follicular lymphoma. By reducing administration time from several hours to just one minute, this CD20xCD3 bispecific antibody offers a more flexible, outpatient-friendly treatment option. Supported by a 75% objective response rate in heavily pre-treated patients, Lunsumio VELO marks a major shift toward patient-centered oncology care in 2025.
European Commission has granted conditional approval for the subcutaneous version of Roche’s bispecific antibody, Lunsumio (mosunetuzumab). This new formulation for relapsed or refractory follicular lymphoma offers high rates of deep and durable responses while reducing treatment administration time from several hours to approximately one minute. This enhanced flexibility promises a better treatment experience for patients and streamlined care delivery in clinics.
Roche announced today that its investigational oral medication, fenebrutinib, has met primary endpoints in two separate, pivotal Phase III studies for both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The drug significantly reduced relapse rates in RMS and slowed disability progression in PPMS, positioning it as a potential first-in-class, high-efficacy oral treatment for the two most common forms of the disease.
Roche’s Phase III ALLEGORY study for Gazyva® (obinutuzumab) in systemic lupus erythematosus (SLE) met its primary and all key secondary endpoints. These “unprecedented” results demonstrate Gazyva’s potential to effectively control disease activity and may delay or prevent further organ damage in people with SLE.
