Redmond – September 22, 2026 -- SystImmune Inc. has secured U.S. Food and Drug Administration clearance for its Investigational New Drug application for SI-B037, a bispecific antibody, marking the first time the company has built a regulatory submission entirely on New Approach Methodologies (NAMs) rather than traditional animal toxicology studies.

Seoul – September 12, 2026 -- SystImmune, Inc. announced that new global Phase 1 data support 2.5 mg/kg D1D8 Q3W as the recommended Phase 3 dose for iza-bren (izalontamab brengitecan), a bispecific EGFRxHER3 antibody drug conjugate, in previously treated EGFR-mutated metastatic non-small cell lung cancer (NSCLC).