pdufa.bio
CalendarDecisionsReadoutsPatents
Drug IndexStocksScreenerConferencesAdvisory Committees
StudiesRun-up by YearLearnGlossaryMethodologyAPIAccount
Pro
Home › PDUFA Calendar › BAYRY

BAYRY PDUFA Date: KERENDIA (finerenone)

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 16, 2026. Decision page with the source and measured reaction.
FDA decision Approved September 16, 2026 · Bayer AG ADR · Type 1 Diabetes and Chronic Kidney Disease
More Obesity & Metabolic FDA decisions →All December 2026 PDUFA dates →

The story

KERENDIA (finerenone) was approved by the FDA on September 16, 2026 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 decisionApproved September 16, 2026
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

New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs.

See the full 2026 PDUFA calendar →

FAQ

What did the FDA decide on BAYRY's KERENDIA (finerenone)?
The FDA decided BAYRY's (Bayer AG ADR) application for KERENDIA (finerenone) on September 16, 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 KERENDIA (finerenone)?
KERENDIA (finerenone) is Bayer AG ADR's drug, approved by the FDA on September 16, 2026 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.