NVO PDUFA Date: Mim8

Name: Mim8 FDA decision
Start: 2026-09-30
End: 2026-09-30

Updated August 7, 2026·next FDA decision on the calendar

FDA decision (PDUFA) target 2026-09-30 · Novo Nordisk A/S · Hemophilia A

More Hematology FDA decisions →All September 2026 PDUFA dates →

The story

Mim8 is under FDA review to treat Hemophilia A.

Full PDUFA calendar ->Every upcoming FDA decision date, by month TLX . 2026-09-11Same month decision . TLX101-Px NUVL-zidesamtinib . 2026-09-18Same month decision . Zidesamtinib (NVL-520)RPRX . 2026-09-18Same month decision . Zidesamtinib (NVL-520)

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)

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

Key facts

FDA PDUFA target date2026-09-30

Drug / candidateMim8

IndicationHemophilia A

CompanyNovo Nordisk A/S

Market-cap tierLarge

Cohort decision-day move (history)±1% median

ClinicalTrials.govNot listed

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

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 2026-09-30 for Mim8. Dates are company/FDA-sourced and can slip. Verify against primary filings.

What is NVO's drug Mim8?

Mim8 is Novo Nordisk A/S's candidate under FDA review for Hemophilia A.

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

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.