Home › FDA Decisions › SWTX 2025-02-11

SWTX FDA Decision Approved · 2025-02-11

Updated September 5, 2026·next FDA decision on the calendar

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.

Decision facts

FDA decision date2025-02-11

DrugGOMEKLI (mirdametinib) - (ReNeu)

IndicationNeurofibromas

Outcome✓ Approvedprimary-sourced

Decision-day move+2.1%

T-120 run-up (low→high)+95.0% ($28.61→$59.28)

ValidationVerified 2026-08-12: Drugs@FDA, application NDA219379, action date 2025-02-11

See the full 2026 PDUFA calendar →

Questions

Was GOMEKLI (mirdametinib) - (ReNeu) approved by the FDA?

Yes. The FDA approved the application for GOMEKLI (mirdametinib) - (ReNeu) on February 11, 2025. The primary source is linked on this page.

What was GOMEKLI (mirdametinib) - (ReNeu) 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.