pdufa.bio
HomeDecisions › LNTH 2026-06-26

LNTH FDA decision — Jun 26, 2026

✕ COMPLETE RESPONSE LETTER

Lantheus Holdings Inc. — LNTH-2501 (Gallium-68 edotreotide) · Neuroendocrine tumors (NETs) in adult and pediatri.

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

PDUFA 6/26/26$109.01$64.251/9/26
Daily close, T-120 (1/9/26) through T+5. Run-up high $109.01 on 6/25/26, low $64.25 on 1/23/26 (T-120 to T-1). FDA decision 6/26/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-06-26
OutcomeCRL
Drug / candidateLNTH-2501 (Gallium-68 edotreotide)
CompanyLantheus Holdings Inc.
120-day run-up (T-120→T-1)+62.0%