Note: NDA filed Dec 18, 2025. Standard review (10 months). REDEFINE 1: 22.7% mean weight reduction. First GLP-1 + amylin combination. PDUFA date estimated (~10 months from filing). [DATE CAVEAT 2026-06-30: Novo discloses only "review expected in 2026"; the Oct 18 day is an aggregator estimate, not company-confirmed.] [QUARTER ONLY 2026-08-02: Novo Nordisk Q1 2026 6-K milestone table lists CagriSema 'US decision' under Q4 2026, not October. The stored day equals submission + 10 months, which is the wrong clock (a standard NME review runs 10 months from the 60-day filing date). Treat the month as unconfirmed.] [DATE UNVERIFIED 2026-10-06: No primary source discloses an exact PDUFA day. Novo filing release (2025-12-18) says only that FDA is expected to review CagriSema in 2026; Novo Q2 2026 report lists the US decision under Q4 2026. Oct 18 is a filing-date + 10-month estimate. Source: https://www.sec.gov/Archives/edgar/data/0000353278/000035327826000023/caq22026.htm]
Drug Information
- Application Type
- NDA
- Indication
- Chronic weight management in adults with obesity or overweight
Filing Details
- Company
- Novo Nordisk A/S →
- Stock Ticker
- NVO
- SEC CIK
- 0000353278
- Source
- PRNewswire →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
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Data sourced from SEC EDGAR filings. Last updated: 2026-04-20. Report an issue