Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
Price into the decision (T-120)
Historical price action; green = local high, red = low/sell-off.
Positioning before the decision
On Jan 28, 2025, 14 days before the decision date, at-the-money options priced a move of ±23.3% through Feb 21, 2025 (the first listed expiry after the decision; ATM implied volatility 115%). The stock closed +2.1% at the first close across the decision and +4.3% 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.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was GOMEKLI (mirdametinib) approved by the FDA?
Yes. The FDA approved the application for GOMEKLI (mirdametinib) on February 11, 2025, per the FDA's own record. The primary source is linked on this page.
What was GOMEKLI (mirdametinib) under FDA review for?
The application covered Neurofibromas. The FDA approved the application on February 11, 2025.
How did SWTX stock react to the FDA decision?
On the decision day SWTX moved +2.1%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.