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BAYRY PDUFA Date: HYRNUO (sevabertinib)

FDA decision (PDUFA) target 2026-11-30 · Bayer AG ADR · HER2-mutated non-small cell lung cancer (NSCLC)

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

$13.28$9.88
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-11-30
Drug / candidateHYRNUO (sevabertinib)
IndicationHER2-mutated non-small cell lung cancer (NSCLC)
CompanyBayer AG ADR
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT05099172 · nan

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FAQ

When is the BAYRY PDUFA date?
The FDA PDUFA target date for BAYRY (Bayer AG ADR) is 2026-11-30 for HYRNUO (sevabertinib). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is BAYRY's drug HYRNUO (sevabertinib)?
HYRNUO (sevabertinib) is Bayer AG ADR's candidate under FDA review for HER2-mutated 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.