Armata Gets FDA Agreement On Pediatric Plan For AP-SA02 In SAB

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source on Google Add Now Armata Pharmaceuticals, Inc. ( ARMP ), a late clinical-stage biotechnology company developing pathogen-specific bacteriophage therapeutics, announced that the U.S. FDA has agreed to its Initial Pediatric Study Plan (iPSP) for AP-SA02. The plan establishes the regulatory framework for evaluating AP-SA02 in pediatric patients with complicated Staphylococcus aureus bacteremia (SAB). Indication Complicated Staphylococcus aureus bacteremia is a serious bloodstream infection caused by methicillin-sensitive S. aureus (MSSA) or methicillin-resistant S. aureus (MRSA) strains. It can lead to severe complications, particularly in vulnerable populations such as premature infants and newborns, who have limited treatment options. Regulatory Milestone Agreement on an iPSP is a required step before submitting a Biologics License Application (BLA). The FDA endorsed Armata's...