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Home › FDA Decisions › IRON 2025-01-21

IRON FDA Decision Approved · 2025-01-21

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 1/21/25$67.47$41.278/6/24
Daily close, T-120 (8/6/24) through T+5. Run-up high $67.47 on 12/16/24, low $41.27 on 8/15/24 (T-120 to T-1). FDA decision 1/21/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-01-21
DrugBitopertin - (APOLLO)
IndicationErythropoietic Protoporphyria (EPP)
Outcome✓ Approvedprimary-sourced
Decision-day move+3.9%
T-120 run-up (low→high)+39.0% ($44.82→$67.47)
ValidationVerified 2026-08-12: SEC filing 0001193125-25-009095 of 2025-01-21 containing 'approval of'
Market-cap tierSmall
Cohort decision-day move (history)3.6% median (n=280)

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 →

Questions

Was Bitopertin - (APOLLO) approved by the FDA?

Yes. The FDA approved the application for Bitopertin - (APOLLO) on January 21, 2025. The primary source is linked on this page.

What was Bitopertin - (APOLLO) under FDA review for?

The application covered Erythropoietic Protoporphyria (EPP). The FDA approved the application on January 21, 2025.

How did IRON stock react to the FDA decision?

On the decision day IRON moved +3.9%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.