Armata announces FDA End-of-Phase 2 response and plan to advance phage cocktail AP-SA02 to a Phase 3 superiority study in complicated S. aureus bacteremia

Armata Pharmaceuticals announced on January 13, 2026 an FDA End-of-Phase 2 written response confirming that safety and efficacy data from its Phase 2a diSArm study support advancing AP-SA02, an intravenous S. aureus bacteriophage cocktail, to a Phase 3 study in complicated S. aureus bacteremia. The Phase 3 superiority study is expected to start in the second half of 2026, with clinical response at the end of best available antibiotic therapy and 28 days later as the primary endpoint; Armata has submitted a request for Qualified Infectious Disease Product designation.