OTSKY FDA decision — Jul 24, 2026
✓ APPROVED
SIMTRIYO (centanafadine) approved — first NDSRI approved for ADHD in adults and pediatric patients 6+ years (≥20kg) (Jul 24 2026)
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Key facts
FDA decision date2026-07-24
OutcomeApproved
Drug / candidateCentanafadine (SIMTRIYO)
IndicationADHD in adults and pediatric patients aged 6 years and older (≥20kg)
CompanyOtsuka Pharmaceutical
Market-cap tierLarge
Cohort decision-day move (history)±1% median
Cohort move is the historical median absolute decision-day move for this market-cap tier — history, not a prediction.
Primary source: Otsuka press release (Otsuka US newsroom, Jul 24 2026)
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