FdaApplication
BLA 125781
Identifiers
- fda_app_no: BLA125781
Properties
| Property | Value |
|---|---|
| applicant_name | Sarepta Therapeutics, Inc. |
| application_type | BLA |
| approval_date | 2023-06-22 |
Revenue by product
ELEVIDYS
| Period | Revenue |
|---|---|
| Q2 2026 | $98.1M |
| Q1 2026 | $102.0M |
| Q4 2025 | $110.4M |
| Q3 2025 | $131.5M |
| Q2 2025 | $281.9M |
| Q1 2025 | $611.5M |
| Q4 2024 | $384.2M |
| Q3 2024 | $181.0M |
| Q2 2024 | $121.7M |
| Q1 2024 | $133.9M |
| Q4 2023 | $131.2M |
| Q3 2023 | $69.1M |
| Q2 2023 | $0.0M |
| Q1 2023 | $0.0M |
| Q4 2022 | $0.0M |
| Q3 2022 | $0.0M |
Revenue as this company reported it for this product. A combination product's amount is stated once, for the product, and never divided across its ingredients. A fourth quarter is the reported full year less nine months, since no filing states one.
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ELEVIDYS | — | 1.33 10E14 vector genomes (vg)/kg/bodyweight(bw) | Suspension |
1 product