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 (6/3/25) through T+5. Run-up high $33.56 on 10/3/25, low $20.3 on 7/7/25 (T-120 to T-1). FDA decision 11/18/25. Historical price action, not a forecast.
Positioning before the decision
On Nov 4, 2025, 14 days before the decision date, at-the-money options priced a move of ±8.7% through Nov 21, 2025 (the first listed expiry after the decision; ATM implied volatility 44%). The stock closed -0.3% at the first close across the decision and +1.3% 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 date2025-11-18
DrugEPKINLY (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was EPKINLY (epcoritamab-bysp) in Combination with Rituximab and Lenalidom approved by the FDA?
Yes. The FDA approved the application for EPKINLY (epcoritamab-bysp) in Combination with Rituximab and Lenalidom on November 18, 2025, per the FDA's own record. The primary source is linked on this page.
What was EPKINLY (epcoritamab-bysp) in Combination with Rituximab and Lenalidom under FDA review for?
The application covered Follicular lymphoma (FL). The FDA approved the application on November 18, 2025.
How did GMAB stock react to the FDA decision?
On the decision day GMAB moved -0.3%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.