Page updated ·next FDA decision on the calendar·Data as of Oct 14, 2026 7:39 PM ET
Price into the decision (T-120)
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
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was MAVYRET (glecaprevir/pibrentasvir) approved by the FDA?
Yes. The FDA approved the application for MAVYRET (glecaprevir/pibrentasvir) on June 10, 2025, per the FDA's own record. The company announced it on June 11, 2025. The primary source is linked on this page.
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.