• The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SIM0505 for the treatment of women with platinum resistant ovarian cancer (PROC) 
  • Phase 1 data for SIM0505 to be presented at ASCO 2026; dose optimization in ovarian cancer expected to begin in Q2 2026

BELTSVILLE, Md., April 07, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc. (NASDAQ:NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today announced that the U.S. Food And Drug Administration (FDA) has granted Fast Track Designation for SIM0505 for the treatment of platinum-resistant ovarian cancer. SIM0505 is an investigational antibody drug conjugate (ADC) comprised of an antibody that targets Cadherin-6 (CDH6) and a proprietary topoisomerase 1 inhibitor (TOPOi) payload.