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OGN FDA Decision Approved · 2025-11-17

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 11/17/25$11.01$6.346/2/25
Daily close, T-120 (6/2/25) through T+5. Run-up high $11.01 on 10/3/25, low $6.34 on 10/29/25 (T-120 to T-1). FDA decision 11/17/25. Historical price action, not a forecast.
Positioning before the decision
On Nov 3, 2025, 14 days before the decision date, at-the-money options priced a move of ±17.8% through Nov 21, 2025 (the first listed expiry after the decision; ATM implied volatility 93%). The stock closed +1.6% at the first close across the decision and -4.1% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.

Decision facts

FDA decision date2025-11-17
DrugPOHERDY (pertuzumab-dpzb) - (PERJETA (pertuzumab) Biosimilar)
IndicationHER2-positive breast cancers
Outcome✓ Approvedprimary-sourced
Decision-day move+1.6%
T-120 run-up (low→high)+14.0% ($6.34→$11.01)
Market-cap tierMicro
Cohort decision-day move (history)4.6% median (n=308)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

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Questions

Was POHERDY (pertuzumab-dpzb) - (PERJETA (pertuzumab) Biosimilar) approved by the FDA?

Yes. The FDA approved the application for POHERDY (pertuzumab-dpzb) - (PERJETA (pertuzumab) Biosimilar) on November 17, 2025. The primary source is linked on this page.

What was POHERDY (pertuzumab-dpzb) - (PERJETA (pertuzumab) Biosimilar) under FDA review for?

The application covered HER2-positive breast cancers. The FDA approved the application on November 17, 2025.

How did OGN stock react to the FDA decision?

On the decision day OGN moved +1.6%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.