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NVS FDA decision: Mar 13, 2026

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

COSENTYX (secukinumab) was approved by the FDA on March 12, 2026 for hidradenitis suppurativa (HS).

Novartis AG, COSENTYX (secukinumab) · Hidradenitis suppurativa (HS).

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

PDUFA 3/13/26$168.62$121.89/26/25
Daily close, T-120 (9/26/25) through T+5. Run-up high $168.62 on 2/27/26, low $121.8 on 11/5/25 (T-120 to T-1). FDA decision 3/13/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-03-13
OutcomeApproved
Drug / candidateCOSENTYX (secukinumab)- (SUNSHINE)
CompanyNovartis AG
120-day run-up (T-120→T-1)+25.5%

FDA record of the action: the FDA approved on March 12, 2026, per BLA 125504 SUPPL-91 (FDA letter). The sponsor announced it on March 13, 2026. 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 COSENTYX (secukinumab) approved by the FDA?

Yes. The FDA approved the application for COSENTYX (secukinumab) on March 12, 2026, per the FDA's own record. The company announced it on March 13, 2026. The primary source is linked on this page.

Which company is behind COSENTYX (secukinumab)?

COSENTYX (secukinumab) is a Novartis AG (NVS) program. The FDA decision came on March 12, 2026; the FDA's own record of the decision is linked on this page.

How did NVS stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), NVS moved +25.5%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.