pdufa.bio
HomeFDA Decisions › GILD 2025-06-18

GILD FDA Decision Approved · 2025-06-18

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 6/18/25$117.41$89.141/1/25
Daily close, T-120 (1/1/25) through T+5. Run-up high $117.41 on 3/11/25, low $89.14 on 1/15/25 (T-120 to T-1). FDA decision 6/18/25. Historical price action, not a forecast.
Positioning before the decision
On Jun 4, 2025, 14 days before the decision date, at-the-money options priced a move of ±8.3% through Jun 20, 2025 (the first listed expiry after the decision; ATM implied volatility 50%). The stock closed +0.0% at the first close across the decision and -1.9% 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 date2025-06-18
DrugYeztugo (Lenacapavir)
IndicationHIV PrEP: Pre-exposure prophylaxis
Outcome✓ Approvedprimary-sourced
Decision-day move+0.0%
T-120 run-up (low→high)+13.0% ($96.91→$117.41)
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 →

Questions

Was Yeztugo (Lenacapavir) approved by the FDA?

Yes. The FDA approved the application for Yeztugo (Lenacapavir) on June 18, 2025. The primary source is linked on this page.

What was Yeztugo (Lenacapavir) under FDA review for?

The application covered HIV PrEP: Pre-exposure prophylaxis. The FDA approved the application on June 18, 2025.

How did GILD stock react to the FDA decision?

On the decision day GILD moved +0.0%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.