Page updated ·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 (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.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
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 13, 2025, per the FDA's own record. The company announced it 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.