AP-SA02 - (diSARM)

July 13, 2026: Armata Pharmaceuticals, Inc. (NYSE: ARMP) announced the FDA has agreed to an Agreed Initial Pediatric Study Plan (iPSP) for AP-SA02 as an adjunct treatment for complicated Staphylococcus aureus bacteremia (SAB) in pediatric patients (up to 17 years). The iPSP agreement is a required regulatory milestone under PREA that must be completed before a future Biologics License Application (BLA) submission.

FDA agreed pediatric studies can be deferred until adult safety/efficacy data are generated in Armata’s planned Phase 3 program, citing consistent SAB pathophysiology and treatment response across age groups and alignment with FDA/EMA frameworks. After completion of the adult Phase 3 study (expected to initiate in 2H 2026), Armata’s proposed pediatric plan is a single multicenter, open-label study assessing safety, tolerability, and clinical response outcomes.

AP-SA02 is a fixed multi-phage cocktail targeting MSSA and MRSA SAB; it has FDA QIDP and Fast Track designations. Armata also noted positive Phase 2a diSArm (NCT05184764) results were presented as a late-breaking oral presentation at IDWeek 2025 (October 2025).