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Home › PDUFA Calendar › BAYRY

BAYRY PDUFA Date: HYRNUO (sevabertinib)

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ Approved · the FDA decided this application on September 9, 2026. Decision page with the source and measured reaction.
FDA decision Approved September 9, 2026 · Bayer AG ADR · HER2-mutated non-small cell lung cancer (NSCLC)
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The story

HYRNUO (sevabertinib) was approved by the FDA on September 9, 2026 to treat HER2-mutated non-small cell lung cancer (NSCLC).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthLNTH-lnth-2501 . 2026-06-29Same area: Oncology . LNTH-2501 (Gallium-68 edotreotide)AZN-truqap . 2026-06-30Same area: Oncology . TruqapBTAI . 2026-11-14Same month decision . IGALMI® (dexmedetomidine)
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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 decisionApproved September 9, 2026
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

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FAQ

What did the FDA decide on BAYRY's HYRNUO (sevabertinib)?
The FDA decided BAYRY's (Bayer AG ADR) application for HYRNUO (sevabertinib) on September 9, 2026: Approved. We do not state a goal date for this application: the date we had carried was never sourced to a filing or company release. Verify against the linked primary source.
What is BAYRY's drug HYRNUO (sevabertinib)?
HYRNUO (sevabertinib) is Bayer AG ADR's drug, approved by the FDA on September 9, 2026 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% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · large-cap cohortn=790 · median +0.0% · 50% up
under -30%: 2 of 790 (0%)<-30-30 to -15%: 2 of 790 (0%)-15 to -7%: 6 of 790 (1%)-7 to -3%: 29 of 790 (4%)-3 to +3%: 707 of 790 (89%)±3+3 to +7%: 35 of 790 (4%)+7 to +15%: 5 of 790 (1%)+15 to +30%: 2 of 790 (0%)over +30%: 2 of 790 (0%)>+30
Distribution of next-day % moves after the FDA decision for large-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.