Armata receives FDA agreement on pediatric study plan for AP-SA02 in S. aureus bacteremia

Armata Pharmaceuticals, Inc.

FDA agreed on Initial Pediatric Study Plan (iPSP) for AP-SA02 as adjunct treatment for complicated S. aureus bacteremia in patients up to 17 years.
iPSP agreement is a regulatory requirement that must be met before submitting a Biologics License Application (BLA).
Pediatric studies will be deferred until adult Phase 3 safety/efficacy data are available; adult Phase 3 expected to start H2 2026.
CEO Dr. Deborah Birx highlighted the milestone as addressing vulnerable pediatric populations with limited treatment options.
AP-SA02 has QIDP and Fast Track designations; Phase 2a results presented at IDWeek 2025.

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