Roche (SIX: ROG; OTCQX: RHHBY) announced Thursday September 17, 2026 that the Phase 3 CELESTIMO trial evaluating Lunsumio (mosunetuzumab, an anti-CD20 x anti-CD3 T-cell-engaging bispecific antibody) plus lenalidomide versus MabThera/Rituxan (rituximab) plus lenalidomide (R2 regimen) in adults with relapsed or refractory follicular lymphoma (R/R FL) who received at least one prior line of treatment met its primary endpoint, showing a statistically significant improvement in progression-free survival (PFS). Overall survival data were immature at the interim analysis. The safety profile of the Lunsumio + lenalidomide combination was consistent with the known profiles of the individual agents, with no new safety signals. Data will be submitted to global health authorities and presented at an upcoming medical meeting. Lunsumio was FDA-approved in December 2022 for third-line-plus R/R FL as a monotherapy; a positive earlier-line CELESTIMO readout positions the drug to challenge the R2 standard-of-care regimen in second-line R/R FL, an approximately $1 billion sales opportunity in the U.S. alone.
Dualitas Therapeutics announced Thursday September 17, 2026 a research collaboration and license agreement with Roche worth up to $1 billion (including $36.5 million upfront plus research, development, and commercial milestone payments and tiered royalties) to discover and develop novel bispecific antibody therapeutics for immunology and inflammation (I&I) indications. Dualitas will apply its DualScreen Bispecific Discovery Engine — a proximity-biology-anchored functional-screening platform — to evaluate more than 300,000 novel bispecific combinations, one of the largest bispecific-screening endeavors publicly announced to date. Roche will assume responsibility for all subsequent preclinical development, regulatory, manufacturing, and commercial activities across the collaboration. The Dualitas platform positions bispecifics as vehicles for synergistic activities unattainable with conventional antibodies. The deal follows Roche's growing focus on I&I as one of its stated therapeutic pillars alongside oncology, neuroscience, and cardiometabolic disease. It also extends Roche's recent deal-making momentum, which included the September 8 Alteogen ALT-B4 subcutaneous-conversion licensing agreement worth up to $3.22 billion.
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).