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ENTA FDA Decision Approved · 2025-06-11

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 6/11/25$8.49$4.2612/25/24
Daily close, T-120 (12/25/24) through T+5. Run-up high $8.49 on 2/27/25, low $4.26 on 4/14/25 (T-120 to T-1). FDA decision 6/11/25. Historical price action, not a forecast.
Positioning before the decision
On May 28, 2025, 14 days before the decision date, at-the-money options priced a move of ±18.3% through Jun 20, 2025 (the first listed expiry after the decision; ATM implied volatility 80%). The stock closed +4.9% at the first close across the decision and -7.0% 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 date2025-06-11
DrugMAVYRET (glecaprevir/pibrentasvir)
IndicationAdults and pediatric patients 3 years and older with acute or chronic hepatitis C virus (H
Outcome✓ Approvedprimary-sourced
Decision-day move+4.9%
T-120 run-up (low→high)+73.0% ($4.26→$8.49)
Market-cap tierMicro
Cohort decision-day move (history)4.6% median (n=308)

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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Questions

Was MAVYRET (glecaprevir/pibrentasvir) approved by the FDA?

Yes. The FDA approved the application for MAVYRET (glecaprevir/pibrentasvir) on June 11, 2025. The primary source is linked on this page.

What was MAVYRET (glecaprevir/pibrentasvir) under FDA review for?

The application covered Adults and pediatric patients 3 years and older with acute or chronic hepatitis C virus (H. The FDA approved the application on June 11, 2025.

How did ENTA stock react to the FDA decision?

On the decision day ENTA moved +4.9%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.