Roche PS

In a registration-relevant head-to-head trial against Lumakras (Amgen) and Krazati (Mirati Therapeutics), Divarasib achieved significant improvements in progression-free survival and overall survival. No new safety signals were observed. Roche plans to submit the data to regulators and present the results at a medical congress. » Mais em finanzen.net

The FDA has accepted the approval application for Roche's drug candidate Giredestrant for review. This brings a potential U.S. approval for Giredestrant one step closer. Further regulatory steps and decisions remain pending. » Mais em finanzen.net

Roche has announced the release of new data from its obesity portfolio. Details on study results or timelines were not mentioned in the text, and investors are awaiting further information on the efficacy and regulatory approval prospects of the treatments. » Mais em finanzen.net

Roche and the UN‑backed organization Medicines Patent Pool have signed a voluntary licensing agreement for the flu medicine Xofluza aimed at low‑ and middle‑income countries. The goal is to improve supply during seasonal outbreaks and potential pandemics; generics manufacturers may develop, produce and distribute the drug in 129 countries. Roche will provide a core data package, reference products for bioequivalence studies and required regulatory approvals, but sublicensees must handle the approval processes themselves. » Mais em finanzen.net

The cancer immunotherapy Tecentriq (Atezolizumab) was approved in the US as an adjuvant therapy for patients with muscle-invasive bladder cancer after bladder removal, when molecular tests detect residual disease. The approval is the eleventh indication for Tecentriq in the US and is based on phase-III trials that reduced relapse rates and the risk of death. In 2025 Tecentriq generated sales of 3.6 billion Swiss francs. » Mais em finanzen.net