Roche

SHERIDAN, WYOMING -- June 15, 2026 -- The U.S. Food and Drug Administration has accepted Roche's supplemental Biologics License Application for Tecentriq and Tecentriq Hybreza in combination with chemotherapy as an adjuvant treatment for stage III dMMR/MSI-H colon cancer following surgery. The FDA has granted Priority Review and is expected to issue a decision by October 9, 2026. The filing is supported by Phase III ATOMIC study data showing a 50% reduction in the risk of disease recurrence or death compared to chemotherapy alone, results published in The New England Journal of Medicine.

SHERIDAN, WYOMING - May 13, 2026 - Roche has received CE Mark for Elecsys® pTau217, a blood-based diagnostic test designed to detect amyloid pathology associated with Alzheimer's disease, developed in collaboration with Eli Lilly and Company. The test measures phosphorylated Tau 217 protein from a routine blood draw and is intended to rule in or rule out amyloid pathology across both primary and secondary care settings using a single-assay design with unified cutoffs. The regulatory clearance positions Elecsys® pTau217 for deployment across Roche's installed base of laboratory instruments in CE mark-accepting countries, with potential FDA clearance in the United States under consideration for later this year.

SHERIDAN, WYOMING - March 13, 2026 - Roche has reported positive Phase II results for petrelintide, an amylin analog being developed for people living with overweight and obesity. According to the company, petrelintide delivered up to 10.7% mean body weight reduction at week 42 compared with 1.7% for placebo, with a p-value of less than 0.001. Roche also said the maximally effective dose showed placebo-like tolerability, with no vomiting cases and no treatment discontinuations due to gastrointestinal adverse events. For the obesity treatment market, the update is relevant because efficacy and tolerability remain central to prescribing, adherence and competitive positioning.