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Home › PDUFA Calendar › BAYRY

BAYRY PDUFA Date: KERENDIA (finerenone)

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-12-31 · Bayer AG ADR · Type 1 Diabetes and Chronic Kidney Disease
More Obesity & Metabolic FDA decisions →All December 2026 PDUFA dates →

The story

KERENDIA (finerenone) is under FDA review to treat Type 1 Diabetes and Chronic Kidney Disease.
Full PDUFA calendar ->Every upcoming FDA decision date, by monthACHV . 2026-06-20Same area: Nephrology . CytisiniclineUNCY . 2026-06-29Same area: Nephrology . Oxylanthanum Carbonate (OLC)EXEL . 2026-12-03Same month decision . XL092 with atezolizumab
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 PDUFA target date2026-12-31
Drug / candidateKERENDIA (finerenone)
IndicationType 1 Diabetes and Chronic Kidney Disease
CompanyBayer AG ADR
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT05901831

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See the full 2026 PDUFA calendar →

FAQ

When is the BAYRY PDUFA date?
The FDA PDUFA target date for BAYRY (Bayer AG ADR) is 2026-12-31 for KERENDIA (finerenone). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is BAYRY's drug KERENDIA (finerenone)?
KERENDIA (finerenone) is Bayer AG ADR's candidate under FDA review for Type 1 Diabetes and Chronic Kidney Disease.
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.