Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
Price into the decision (T-120)
Daily close, T-120 (9/9/24) through T+5. Run-up high $12.5 on 9/10/24, low $7.46 on 10/21/24 (T-120 to T-1). FDA decision 2/24/25. Historical price action, not a forecast.
Positioning before the decision
On Feb 10, 2025, 14 days before the decision date, at-the-money options priced a move of ±30.9% through Mar 21, 2025 (the first listed expiry after the decision; ATM implied volatility 172%). The stock closed -2.4% at the first close across the decision and +9.3% 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 date2025-02-24
DrugSUBLOCADE (buprenorphine extended-release)
IndicationModerate to severe opioid use disorder (OUD)
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was SUBLOCADE (buprenorphine extended-release) approved by the FDA?
Yes. The FDA approved the application for SUBLOCADE (buprenorphine extended-release) on February 21, 2025, per the FDA's own record. The company announced it on February 24, 2025. The primary source is linked on this page.
What was SUBLOCADE (buprenorphine extended-release) under FDA review for?
The application covered Moderate to severe opioid use disorder (OUD). The FDA approved the application on February 24, 2025.
How did INDV stock react to the FDA decision?
On the decision day INDV moved -2.4%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.