Innovative Medicine

Median overall survival improvement projected to exceed one year with much-anticipated overall survival analysis showing statistically superior result versus osimertinib Preventative dermatologic regimen meets primary endpoint and enhances patient experience

Sjögren’s disease (SjD) is a prevalent, debilitating autoantibody disease with no FDA-approved advanced treatments The Company is actively enrolling patients in the Phase 3 DAFFODIL study This marks the fourth nipocalimab FDA Fast Track designation

Topline results also show investigational targeted oral peptide icotrokinra achieved clinical remission rates up to 30.2% at Week 12 and a favorable safety profile in Phase 2b ANTHEM-UC study Clinical response and remission rates continued to improve through Week 28, building on strong data recently reported for the plaque psoriasis Phase 3 program Icotrokinra demonstrates potential to offer therapeutic benefit and tolerability with a once daily oral treatment

Standout combination of complete skin clearance and favorable safety profile in a once daily pill could shift treatment paradigm Nearly half of patients with moderate-to-severe plaque psoriasis (PsO) treated with investigational icotrokinra achieved completely clear skin (IGA 0) at Week 24 in Phase 3 ICONIC-LEAD Topline results from Phase 3 ICONIC-ADVANCE 1&2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe plaque PsO These results pave the way to initiate the first-ever head-to-head study seeking to demonstrate the superiority of a pill versus injectable biologic in moderate-to-severe plaque PsO

If approved, daratumumab will be the only anti-CD38 available for all patient types across newly diagnosed multiple myeloma, cementing daratumumab as a foundational therapy in the frontline setting. Recommendation supported by results from CEPHEUS, the fifth Phase 3 study of daratumumab to demonstrate improved progression free survival in the frontline setting.1,2,3,4

Phase 3 ASTRO study achieves primary and all secondary endpoints at Week 12 in ulcerative colitis patients The only SC induction data for an IL-23 inhibitor show statistically significant and clinically meaningful improvements across clinical and endoscopic measures versus placebo, consistent with IV induction

Published results reinforce the high-affinity binding and immunoselective properties of nipocalimab, which has been shown to reduce IgG levels by >75%, including autoantibodies, potentially without affecting other immune functions

Independent, scheduled review finds investigational vaccine regimen lacks efficacy in preventing invasive E. coli disease (IED) No safety signals identified