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

Armata Pharmaceuticals (ARMP) said the U.S. FDA agreed to its Initial Pediatric Study Plan (iPSP) for AP-SA02, outlining the agreed pediatric development/regulatory pathway. The milestone reduces regulatory uncertainty for pediatric advancement of its pathogen-specific bacteriophage therapeutics and is supportive for clinical and regulatory progress.

Analysis

Armata Pharmaceuticals (ARMP) said the U.S. FDA agreed to its Initial Pediatric Study Plan (iPSP) for AP-SA02, outlining the agreed pediatric development/regulatory pathway. The milestone reduces regulatory uncertainty for pediatric advancement of its pathogen-specific bacteriophage therapeutics and is supportive for clinical and regulatory progress.