Unverified record. The outcome below was inferred from the share-price reaction around this date. Nobody has confirmed it against an FDA, SEC or company document, and it may be wrong: we have published at least one inferred outcome that turned out to be impossible (see corrections). Treat it as a price observation, not as a regulatory fact. Verified decisions on this site always link a primary source.
pdufa.bio
HomeFDA Decisions › PFE 2025-08-27

PFE FDA Decision outcome unverified · 2025-08-27

Rebuilt daily·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 8/27/25$26.73$21.593/12/25
Daily close, T-120 (3/12/25) through T+5. Run-up high $26.73 on 3/13/25, low $21.59 on 4/16/25 (T-120 to T-1). FDA decision 8/27/25. Historical price action, not a forecast.
Positioning before the decision
On Aug 13, 2025, 14 days before the decision date, at-the-money options priced a move of ±3.4% through Aug 29, 2025 (the first listed expiry after the decision; ATM implied volatility 20%). The stock closed +0.6% at the first close across the decision and -0.5% 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 date2025-08-27
OutcomeUnconfirmed · price consistent with approval~ price-only (validating)
Decision-day move+0.6%
T-120 run-up (low→high)+13.0% ($22.02→$25.88)
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierLarge
Cohort decision-day move (history)1.0% median (n=835)

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 →