Daily close, T-120 (2/10/25) through T+5. Run-up high $30.37 on 2/12/25, low $16.36 on 5/20/25 (T-120 to T-1). FDA decision 7/28/25. Historical price action, not a forecast.
Positioning before the decision
On Jul 14, 2025, 14 days before the decision date, at-the-money options priced a move of ±20.3% through Aug 15, 2025 (the first listed expiry after the decision; ATM implied volatility 86%). The stock closed -4.3% at the first close across the decision and +17.2% 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.
Was EMPAVELI (pegcetacoplan) - (VALIANT) approved by the FDA?
Yes. The FDA approved the application for EMPAVELI (pegcetacoplan) - (VALIANT) on July 28, 2025. The primary source is linked on this page.
What was EMPAVELI (pegcetacoplan) - (VALIANT) under FDA review for?
The application covered C3G and IC-MPGN. The FDA approved the application on July 28, 2025.
How did APLS stock react to the FDA decision?
On the decision day APLS moved -4.3%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.