pdufa.bio
HomeDecisions › ZVRA 2026-06-08

ZVRA FDA decision — Jun 8, 2026

✓ APPROVED

Zevra Therapeutics Inc. — MIPLYFFA (MY-PLY-FAH) (arimoclomol) · Niemann-Pick disease Type C (NPC).

Run-up into the decision (T-120 → T+5)

PDUFA 6/8/26$11.66$8.112/22/25
Daily close, T-120 (12/22/25) through T+5. Run-up high $11.66 on 5/15/26, low $8.1 on 12/26/25 (T-120 to T-1). FDA decision 6/8/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-06-08
OutcomeApproved
Drug / candidateMIPLYFFA (MY-PLY-FAH) (arimoclomol)
CompanyZevra Therapeutics Inc.
120-day run-up (T-120→T-1)+27.4%