Daily close, T-120 (9/19/25) through T+5. Run-up high $78.84 on 3/3/26, low $50.11 on 9/29/25 (T-120 to T-1). FDA decision 3/6/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-03-06
OutcomeApproved
Drug / candidatePYLARIFY TruVu (piflufolastat F 18) Injectio
CompanyLantheus Holdings Inc.
120-day run-up (T-120→T-1)+44.1%
FDA record of the action: the FDA approved on March 6, 2026, per NDA 220089 ORIG-1 (Drugs@FDA). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Questions
Was PYLARIFY TruVu (piflufolastat F 18) approved by the FDA?
Yes. The FDA approved the application for PYLARIFY TruVu (piflufolastat F 18) on March 6, 2026, per the FDA's own record. The primary source is linked on this page.
Which company is behind PYLARIFY TruVu (piflufolastat F 18)?
PYLARIFY TruVu (piflufolastat F 18) is a Lantheus Holdings Inc. (LNTH) program. The FDA decision came on March 6, 2026; the FDA's own record of the decision 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 +44.1%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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