Page updated ·next FDA decision on the calendar·Data as of Oct 14, 2026 7:39 PM ET
Price into the decision (T-120)
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)
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was Susvimo (ranibizumab injection) 100 mg/mL approved by the FDA?
Yes. The FDA approved the application for Susvimo (ranibizumab injection) 100 mg/mL on February 3, 2025, per the FDA's own record. The company announced it on February 4, 2025. The primary source is linked on this page.
What was Susvimo (ranibizumab injection) 100 mg/mL 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.