Trethera Announces FDA Orphan Drug Designation Granted to TRE-515 in the Treatment of Acute Disseminated Encephalomyelitis
Trethera announced FDA Orphan Drug Designation for TRE‑515 in acute disseminated encephalomyelitis (ADEM). This early-stage recognition offers incentives including trial design support, FDA grant eligibility, fee exemptions, and seven years of U.S. exclusivity.