pdufa.bio
CalendarDecisionsReadoutsPatents
Drug IndexStocksScreenerConferencesAdvisory Committees
StudiesRun-up by YearLearnGlossaryMethodologyAPIAccount
Pro
Home › FDA Decisions › NVO 2025-10-15

NVO FDA Decision Approved · 2025-10-15

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

Price into the decision (T-120)

PDUFA 10/15/25$81.05$45.384/30/25
Daily close, T-120 (4/30/25) through T+5. Run-up high $81.05 on 6/17/25, low $45.38 on 8/7/25 (T-120 to T-1). FDA decision 10/15/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-10-15
DrugRybelsus (oral semaglutide)
IndicationMajor adverse cardiovascular events in adults with type 2 diabetes and cardiovascular dise
Outcome✓ Approvedprimary-sourced
Decision-day move+0.1%
T-120 run-up (low→high)+0.0% ($45.38→$79.83)
ValidationVerified 2026-08-12: Drugs@FDA, application NDA213051, action date 2025-10-17
Market-cap tierLarge
Cohort decision-day move (history)1.0% median (n=895)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

See the full 2026 PDUFA calendar →

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.

Questions

Was Rybelsus (oral semaglutide) approved by the FDA?

Yes. The FDA approved the application for Rybelsus (oral semaglutide) on October 17, 2025, per the FDA's own record. The company announced it on October 15, 2025. The primary source is linked on this page.

What was Rybelsus (oral semaglutide) under FDA review for?

The application covered Major adverse cardiovascular events in adults with type 2 diabetes and cardiovascular dise. The FDA approved the application on October 15, 2025.

How did NVO stock react to the FDA decision?

On the decision day NVO moved +0.1%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.