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Home › PDUFA Calendar › NVO

NVO PDUFA Date: AM833 (CagriSema)

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-12-31 · Novo Nordisk A/S · Obesity
More Obesity & Metabolic FDA decisions →All December 2026 PDUFA dates →

The story

AM833 (CagriSema) is under FDA review to treat obesity / chronic weight management (the CagriSema combination).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthIONS-olezarsen . 2026-06-30Same area: Metabolic / Cardio . OlezarsenMRK-winrevair . 2026-09-21Same area: Metabolic / Cardio . WINREVAIR (sotatercept-csrk)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.

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

$49.23$35.29
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 / candidateAM833 (CagriSema)
IndicationObesity
CompanyNovo Nordisk A/S
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT03787225

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See the full 2026 PDUFA calendar →

FAQ

When is the NVO PDUFA date?
The FDA PDUFA target date for NVO (Novo Nordisk A/S) is 2026-12-31 for AM833 (CagriSema). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is NVO's drug AM833 (CagriSema)?
AM833 (CagriSema) is Novo Nordisk A/S's candidate under FDA review for Obesity.
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.