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ALVO FDA Decision Approved · 2025-05-05

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

Price into the decision (T-120)

Daily close, T-120 (11/18/24) through T+5. Run-up high $13.52 on 1/15/25, low $7.84 on 4/30/25 (T-120 to T-1). FDA decision 5/5/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-05-05

DrugSELARSDI (ustekinumab-aekn) injection - (STELARA biosimilar)

IndicationAdults and pediatric psoriatic arthritis and plaque psoriasis

Outcome✓ Approvedprimary-sourced

Decision-day move+1.3%

T-120 run-up (low→high)+3.0% ($7.84→$13.52)

ValidationVerified 2026-08-12: Drugs@FDA, application BLA761343, action date 2025-04-30

Market-cap tierMicro

Cohort decision-day move (history)4.7% median (n=312)

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 SELARSDI (ustekinumab-aekn) injection approved by the FDA?

Yes. The FDA approved the application for SELARSDI (ustekinumab-aekn) injection on April 30, 2025, per the FDA's own record. The company announced it on May 5, 2025. The primary source is linked on this page.

What was SELARSDI (ustekinumab-aekn) injection under FDA review for?

The application covered Adults and pediatric psoriatic arthritis and plaque psoriasis. The FDA approved the application on May 5, 2025.

How did ALVO stock react to the FDA decision?

On the decision day ALVO moved +1.3%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.