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Home › FDA Decisions › RHHBY 2025-02-12

RHHBY FDA Decision Approved · 2025-02-12

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 2/12/25$42.33$34.248/28/24
Daily close, T-120 (8/28/24) through T+5. Run-up high $42.33 on 9/9/24, low $34.24 on 12/25/24 (T-120 to T-1). FDA decision 2/12/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-02-12
DrugEVRYSDI (risdiplam) 5mg
IndicationSpinal muscular atrophy (SMA)
Outcome✓ Approvedprimary-sourced
Decision-day move+2.0%
T-120 run-up (low→high)+5.0% ($34.24→$41.29)
ValidationVerified 2026-08-12: Drugs@FDA, application NDA213535, action date 2025-02-11
Market-cap tierLarge
Cohort decision-day move (history)1.0% median (n=835)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

See the full 2026 PDUFA calendar →

Questions

Was EVRYSDI (risdiplam) 5mg approved by the FDA?

Yes. The FDA approved the application for EVRYSDI (risdiplam) 5mg on February 12, 2025. The primary source is linked on this page.

What was EVRYSDI (risdiplam) 5mg under FDA review for?

The application covered Spinal muscular atrophy (SMA). The FDA approved the application on February 12, 2025.

How did RHHBY stock react to the FDA decision?

On the decision day RHHBY moved +2.0%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.