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ALPMY FDA Decision Approved · 2025-02-13

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 (8/29/24) through T+5. Run-up high $12.64 on 9/16/24, low $9.15 on 2/4/25 (T-120 to T-1). FDA decision 2/13/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-02-13

DrugIZERVAY (avacincaptad pegol intravitreal solution)

IndicationGeographic atrophy (GA) secondary to age-related macular degeneration (AMD)

Outcome✓ Approvedprimary-sourced

Decision-day move+4.1%

T-120 run-up (low→high)+5.0% ($9.15→$12.3)

ValidationVerified 2026-08-12: Drugs@FDA, application NDA217225, action date 2025-02-12

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 IZERVAY (avacincaptad pegol intravitreal solution) approved by the FDA?

Yes. The FDA approved the application for IZERVAY (avacincaptad pegol intravitreal solution) on February 12, 2025, per the FDA's own record. The company announced it on February 13, 2025. The primary source is linked on this page.

What was IZERVAY (avacincaptad pegol intravitreal solution) under FDA review for?

The application covered Geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The FDA approved the application on February 13, 2025.

How did ALPMY stock react to the FDA decision?

On the decision day ALPMY moved +4.1%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.