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Home › FDA Decisions › RHHBY 2025-02-04

RHHBY FDA Decision Approved · 2025-02-04

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 2/4/25$42.33$34.248/20/24
Daily close, T-120 (8/20/24) 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 2/4/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-02-04
DrugSusvimo (ranibizumab injection) 100 mg/mL - (Pagoda and Pavilion)
IndicationDiabetic macular edema (DME) and diabetic retinopathy (DR)
Outcome✓ Approvedprimary-sourced
Decision-day move+0.8%
T-120 run-up (low→high)+6.0% ($34.24→$40.57)
ValidationVerified 2026-08-12: Drugs@FDA, application BLA761197, action date 2025-02-03
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 Susvimo (ranibizumab injection) 100 mg/mL - (Pagoda and Pavilion) approved by the FDA?

Yes. The FDA approved the application for Susvimo (ranibizumab injection) 100 mg/mL - (Pagoda and Pavilion) on February 4, 2025. The primary source is linked on this page.

What was Susvimo (ranibizumab injection) 100 mg/mL - (Pagoda and Pavilion) under FDA review for?

The application covered Diabetic macular edema (DME) and diabetic retinopathy (DR). The FDA approved the application on February 4, 2025.

How did RHHBY stock react to the FDA decision?

On the decision day RHHBY moved +0.8%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.