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.
Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Gazyva/Gazyvaro (obinutuzumab) for the treatment of adult patients with active lupus nephritis. Based on positive results from Phase II and III clinical trials, this new therapy offers a significant advancement for those suffering from this severe kidney complication of lupus, showing superiority over standard therapy alone.
Leading pharmaceutical companies including Roche, Eli Lilly, AbbVie, and Gilead/Kite are set to present significant new data from their oncology pipelines at the ESMO Congress 2025 in Berlin (Oct 17-21). Presentations will highlight advancements in targeted therapies, ADCs, and cell therapy for multiple cancer types, focusing on key drugs like Tecentriq, Verzenio, and Trodelvy.
In a major breakthrough for oncology, the U.S. FDA has approved a new combination therapy from Roche for a highly aggressive form of lung cancer. The treatment, which combines Tecentriq® (atezolizumab) and lurbinectedin (Zepzelca®), is the first of its kind for the maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC). Clinical trial results show the regimen significantly reduces the risk of disease progression and death, offering new hope and a pivotal shift in how this challenging disease is managed post-chemotherapy.
Roche is set to present a wealth of new data at the 41st ECTRIMS Congress, highlighting the expanding benefits of its flagship multiple sclerosis therapy, OCREVUS® (ocrelizumab). New findings demonstrate a significant reduction in disability progression for adults with advanced primary progressive MS (PPMS) and reinforce its safety for pregnant women and their infants. The presentation will also include the first comparative data for OCREVUS in pediatric MS. Alongside these updates, Roche will showcase promising two-year results for its investigational oral BTK inhibitor, fenebrutinib, which showed near-complete suppression of disease activity in patients with relapsing MS ahead of pivotal Phase III readouts.
