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NVO FDA decision: Mar 3, 2026

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

Sogroya (somapacitan) was approved by the FDA for Noonan syndrome (NS); the approval was announced on March 3, 2026.

Novo Nordisk A/S, Sogroya (somapacitan) · Noonan syndrome (NS).

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

PDUFA 3/3/26$63.98$37.459/16/25
Daily close, T-120 (9/16/25) through T+5. Run-up high $63.98 on 1/27/26, low $37.45 on 2/27/26 (T-120 to T-1). FDA decision 3/3/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-03-03
OutcomeApproved
Drug / candidateSogroya (somapacitan) - (REAL8)
CompanyNovo Nordisk A/S
120-day run-up (T-120→T-1)-30.5%

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