FDA grants Breakthrough Therapy designation to Armata’s AP-SA02 for complicated S. aureus bacteremia

Armata Pharmaceuticals announced on September 14, 2026 that the US FDA has granted Breakthrough Therapy designation to AP-SA02, its intravenous multi-phage product candidate for adjunct treatment of complicated Staphylococcus aureus bacteremia caused by MSSA or MRSA. Armata says the designation is supported by its Phase 1b/2a diSArm study, in which 100% of AP-SA02-treated patients maintained clinical response without relapse 28 days after antibiotic therapy versus 75% on placebo, and plans a Phase 3 superiority study anticipated to start in the second half of 2026.