What is Orphan Drug Designation (ODD)?
FDA status for drugs targeting rare diseases (under 200,000 US patients) — market exclusivity plus incentives.
ODD grants seven years of market exclusivity on approval, tax credits for clinical trials, and regulatory fee waivers. It is per indication: one drug can hold many orphan designations.
Because prevalence thresholds are generous, ODD announcements are mild catalysts — the market cares far more about the data behind them.
See it live: the catalyst calendar · status-change feed