pdufa.bio
Home › Decisions › NVO 2026-03-19

NVO FDA decision: Mar 19, 2026

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED

Wegovy HD was approved by the FDA on March 19, 2026 for obesity.

Novo Nordisk A/S, Wegovy HD · Obesity.

Run-up into the decision (T-120 → T+5)

PDUFA 3/19/26$63.98$36.6610/2/25
Daily close, T-120 (10/2/25) through T+5. Run-up high $63.98 on 1/27/26, low $36.66 on 3/3/26 (T-120 to T-1). FDA decision 3/19/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-03-19
OutcomeApproved
Drug / candidateWegovy HD
CompanyNovo Nordisk A/S
120-day run-up (T-120→T-1)-33.2%

FDA record of the action: the FDA approved on March 19, 2026, per NDA 215256 SUPPL-29 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.

Questions

Was Wegovy HD approved by the FDA?

Yes. The FDA approved the application for Wegovy HD on March 19, 2026, per the FDA's own record. The primary source is linked on this page.

Which company is behind Wegovy HD?

Wegovy HD is a Novo Nordisk A/S (NVO) program. The FDA decision came on March 19, 2026; the FDA's own record of the decision is linked on this page.

How did NVO stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), NVO moved -33.2%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.