FdaApplication
BLA 761485
Identifiers
- fda_app_no: BLA761485
Properties
| Property | Value |
|---|---|
| applicant_name | Denali Therapeutics Inc. |
| application_type | BLA |
| approval_date | 2026-03-24 |
Revenue by product
AVLAYAH
| Period | Revenue |
|---|---|
| Q2 2026 | $3.6M† |
| Q2 2025 | $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 figure marked † is the company's one reported revenue line rather than a product breakdown.
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| AVLAYAH | TIVIDENOFUSP ALFA-EKNM | 150MG | For Injection |
1 product