pdufa.bio
HomeResearch › Implied vs actual

What the options market priced before FDA decisions, and what happened

Updated ·next FDA decision on the calendar
Across 1073 FDA decisions from 2020 to 2026, at-the-money options roughly two weeks out priced a median move of ±6.7%. The median move at the first close after the decision was 1.4%, and within five trading days 3.1%. The actual move exceeded what was priced in 3.1% of cases at one day and 17.1% within five.

Read these two caveats before any number below

1. A straddle two weeks out prices two weeks of ordinary movement plus the event. Every figure here is the move the options market priced from the snapshot date through the first expiry after the decision. It is not the event-implied move, and this page never calls it that.

2. These are measurements of history, published with their distribution. They describe what happened across this sample of decisions. They are not a property of future decisions, not a strategy, and not investment advice; option prices reflect risks (including total loss) this page does not measure.

By year

Median priced move (T-14 ATM straddle) vs median first-close move, FDA decisions with a computable chain, by year. Updated Sep 5, 2026.
YearnMedian pricedMedian actual (1st close)Exceeded priced
2020143±7.5%1.6%3
2021174±6.0%1.2%10
2022143±6.3%1.7%2
2023211±5.9%1.2%5
2024203±6.3%1.2%3
2025190±8.2%1.5%10
20269±23.1%4.9%0

The largest realized moves, against what was priced

Ten largest five-day moves in the sample. "Priced" is the ATM straddle at the snapshot; both actual horizons shown because reactions can build over days.
TickerDecisionPriced (T-14)Next close5 trading daysATM IV
URGNJun 12, 2025±74.5%+51.8%+103.7%394%
PGENAug 15, 2025±60.7%+58.9%+96.8%224%
OMERDec 24, 2025±49.6%+75.5%+96.3%204%
CPIXDec 9, 2024±115.7%+0.0%+91.9%251%
GRTXAug 9, 2023±50.6%+6.2%-87.2%253%
APLTNov 27, 2024±47.0%-16.1%-86.5%177%
AKBAMar 30, 2022±66.0%-66.0%-75.2%289%
REPLJul 22, 2025±47.0%-77.2%-74.3%179%
MESOAug 3, 2023±49.1%+0.0%-69.2%218%
OTLKDec 31, 2025±91.8%-15.3%-68.4%411%

Method and coverage

Universe: the 1796 PDUFA events in our run-up study. For each event we take the options chain snapshot closest to 14 days before the decision (accepted anywhere in the prior 30 days; the snapshot date is recorded per event), the nearest listed expiry after the decision date, and the at-the-money straddle mid divided by the stock price. The actual move is the study's own close-to-close move across the decision (the eve close to the first close after, and to the fifth trading day after), so this page and the run-up study cannot disagree about what happened. 1073 events (59.7%) were computable; coverage requires listed options with real two-sided quotes, so small and nano-cap names are underrepresented, and the aggregate figures describe the computable set, not every FDA decision.

Questions

What does the priced move measure?
For each decision we take the options chain snapshot closest to 14 days before the decision, the nearest listed expiry after it, and the at-the-money straddle (call mid plus put mid) divided by the stock price. That is the move the options market priced from the snapshot date through that expiry. It prices roughly two weeks of ordinary movement PLUS the event, so it is not the event-implied move alone.
How often did the actual move exceed what was priced?
At the first close after the decision, 33 of 1073 (3.1%). Within five trading days, 183 of 1073 (17.1%). The gap between those two rates is itself a finding: a large share of the realized move arrives after the first close. These are historical measurements of this sample, not a property of future decisions.
Which events are covered?
1073 of the 1796 events in our run-up study (59.7%) had a usable options chain snapshot in the 30 days before the decision. Coverage requires listed options with real quotes, so the computable set skews toward larger, optionable companies; the smallest names are underrepresented.

Historical measurements of specific decisions from recorded options quotes. Nothing here predicts any pending application or recommends any position. Not investment advice.