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.
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MRNA FDA Decision outcome unverified · 2025-06-12

Rebuilt daily·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 6/12/25$47.53$23.6512/26/24
Daily close, T-120 (12/26/24) through T+5. Run-up high $47.53 on 1/14/25, low $23.65 on 5/16/25 (T-120 to T-1). FDA decision 6/12/25. Historical price action, not a forecast.
Positioning before the decision
On May 29, 2025, 14 days before the decision date, at-the-money options priced a move of ±12.2% through Jun 13, 2025 (the first listed expiry after the decision; ATM implied volatility 75%). The stock closed -1.4% at the first close across the decision and -8.5% 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 date2025-06-12
OutcomeUnconfirmed · price consistent with approval~ price-only (validating)
Decision-day move-1.4%
T-120 run-up (low→high)+13.0% ($23.65→$35.96)
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.

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