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)
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was LNTH-2501 (Gallium-68 edotreotide) approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for LNTH-2501 (Gallium-68 edotreotide) in its current form, was announced on June 26, 2026. A CRL is not final; the primary source is linked on this page.
Which company is behind LNTH-2501 (Gallium-68 edotreotide)?
LNTH-2501 (Gallium-68 edotreotide) is a Lantheus Holdings Inc. (LNTH) program. The company announced the FDA decision on June 26, 2026; the company's own announcement is linked on this page.
How did LNTH stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), LNTH moved +62.0%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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