Roche announced on Thursday, September 17, 2026 that the Phase 3 CELESTIMO trial met its primary endpoint: Lunsumio (mosunetuzumab) plus lenalidomide produced a statistically significant improvement in progression-free survival versus rituximab plus lenalidomide in people with relapsed or refractory follicular lymphoma who had received at least one prior line of treatment. Overall survival data were immature at the interim analysis, and safety was consistent with the known profiles of both drugs, with no new signals. CELESTIMO is the confirmatory study required to convert the accelerated approval and conditional authorization of Lunsumio monotherapy for third-line or later follicular lymphoma into full approval. Roche will submit the data to health authorities and present them at an upcoming medical meeting.
Dualitas Therapeutics announced on Thursday, September 17, 2026 a research collaboration and license agreement with Roche to discover bispecific antibodies for immunology and inflammation diseases. Dualitas receives $36.5 million upfront and can earn research, development, and commercial milestones plus tiered royalties, for a total potential value of up to $1 billion. It will use its DualScreen Bispecific Discovery Engine to functionally screen more than 300,000 novel bispecific combinations, and Roche will handle all later preclinical development, regulatory, manufacturing, and commercial work.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced Thursday September 10, 2026 that the FDA granted Priority Review to a supplemental Biologics License Application (sBLA) for Enspryng (satralizumab, a humanized anti-interleukin-6 receptor monoclonal antibody using recycling-antibody technology for extended IL-6 receptor blockade) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). MOGAD is a rare inflammatory central nervous system disorder attacking optic nerves, brain, and spinal cord with estimated prevalence of 0.51 to 3.42 per 100,000 people. It has no FDA-approved disease-modifying treatments. The Phase 3 METEOROID trial met its primary endpoint of time to first relapse during double-blind treatment with a 68% reduction in relapse risk versus placebo (p=0.0025) and secondary endpoints including 87% of Enspryng-treated patients relapse-free at 48 weeks (versus 67% on placebo), 66% lower annualized relapse rate, 79% fewer active MRI lesions, and 73% reduced rescue-therapy use. The FDA action date is January 10, 2027. Enspryng is currently approved in approximately 90 countries for neuromyelitis optica spectrum disorder (NMOSD).