pdufa.bio
HomeDecisionsLGND 2026-06-08

LGND FDA decision: Jun 8, 2026

Updated ·next FDA decision on the calendar
✓ APPROVED

Ligand Pharmaceuticals Incorporated, MIPLYFFA (MY-PLY-FAH) (arimoclomol) · Niemann-Pick disease Type C (NPC).

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

PDUFA 6/8/26$241.79$181.6512/22/25
Daily close, T-120 (12/22/25) through T+5. Run-up high $241.79 on 4/28/26, low $181.65 on 2/17/26 (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)
CompanyLigand Pharmaceuticals Incorporated
120-day run-up (T-120→T-1)+25.0%

Questions

Was MIPLYFFA (MY-PLY-FAH) (arimoclomol) approved by the FDA?

Yes. The FDA approved the application for MIPLYFFA (MY-PLY-FAH) (arimoclomol) on June 8, 2026. The primary source is linked on this page.

Which company is behind MIPLYFFA (MY-PLY-FAH) (arimoclomol)?

MIPLYFFA (MY-PLY-FAH) (arimoclomol) is a Ligand Pharmaceuticals Incorporated (LGND) program. The FDA decision came on June 8, 2026; the company's own announcement is linked on this page.

How did LGND stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), LGND moved +25.0%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.