Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
MIPLYFFA (MY-PLY-FAH) (arimoclomol) was approved by the FDA for Niemann-Pick disease Type C (NPC); the approval was announced on June 8, 2026.
Zevra Therapeutics Inc., MIPLYFFA (MY-PLY-FAH) (arimoclomol) · Niemann-Pick disease Type C (NPC).
Run-up into the decision (T-120 → T+5)
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%
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
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