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RPRX PDUFA Date: Zidesamtinib (NVL-520)

FDA decision (PDUFA) target 2026-09-18 · Royalty Pharma plc · ROS1 Non-small cell lung cancer (NSCLC)

RPRX run-up into the PDUFA (last ~120 days)

$55.87$45.11
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-09-18
Drug / candidateZidesamtinib (NVL-520)
IndicationROS1 Non-small cell lung cancer (NSCLC)
CompanyRoyalty Pharma plc
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT05118789 · recruiting

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FAQ

When is the RPRX PDUFA date?
The FDA PDUFA target date for RPRX (Royalty Pharma plc) is 2026-09-18 for Zidesamtinib (NVL-520). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is RPRX's drug Zidesamtinib (NVL-520)?
Zidesamtinib (NVL-520) is Royalty Pharma plc's candidate under FDA review for ROS1 Non-small cell lung cancer (NSCLC).
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.