The FDA has approved Roche's obinutuzumab (Gazyva), an anti-CD20 agent, for treating idiopathic nephrotic syndrome in patients as young as 2 years old. This marks the first new drug approval for this kidney condition in seven decades.
Roche's Genentech is paying Earendil Labs $55 million upfront in a research collaboration to discover and develop multiple bispecific antibody cancer therapies. The oncology-focused deal includes milestone payments that could bring its total value to over $1.5 billion.
Swiss drugmaker Roche has entered a partnership with Atavistik Bio potentially worth nearly $2 billion, including milestone payments, to develop oral treatments for cardiovascular, kidney and metabolic diseases. The deal includes $70 million upfront with an additional $1.9 billion in potential milestone payments.
Roche's experimental RNA drug sefaxersen significantly reduced proteinuria in a late-stage trial for IgA nephropathy, positioning the company to bring a new treatment to market for the autoimmune kidney disease that currently has limited approved therapies.
Roche's experimental obesity shot enicepatide reduced blood sugar and body weight by 15.5% in type-2 diabetes patients in a mid-stage trial, with a meaningful proportion reaching normalized glucose levels within less than a year of treatment.
Roche announced that its T-cell engager Lunsumio successfully met the primary endpoint in a confirmatory phase 3 trial for earlier-line follicular lymphoma treatment. The company is now pursuing a label expansion for the drug based on these positive results.
Roche acquired rights to Hanmi Pharmaceutical's obesity drug for $190 million upfront and up to $2.3 billion total. The drug is designed to activate receptors in skeletal muscle to increase muscle mass while reducing fat, addressing a key concern with current GLP-1 weight loss medications.
Roche announced positive results from a head-to-head Phase 3 trial showing its KRAS G12C inhibitor divarasib demonstrated superior efficacy compared to competing treatments from Amgen and Bristol Myers Squibb in patients with KRAS-driven lung cancer.
Swiss pharmaceutical giant Roche has signed an exclusive licensing and collaboration agreement with Nurix Therapeutics for bexobrutinib, a protein degrader drug targeting B cell malignancies and blood cancers. The deal value is reported as up to $2.3 billion by one source and up to $3 billion by another.
Swiss drugmaker Roche presented latest clinical trial data for its experimental multiple sclerosis drug at a major conference, setting the stage for regulatory approval submissions, though safety questions remain under scrutiny.
The FDA is reviewing a petition to revoke approval of ocrelizumab (Ocrevus), Roche's top-selling drug, for treating primary progressive MS, raising questions about whether the drug may be causing more harm than good in this patient population.
