- The FDA has accepted Roche Holding AG's RHHBY Biologics License Application seeking approval for faricimab in neovascular of wet age-related macular degeneration (nAMD) and diabetic macular edema (DME).
- The application is under priority review. The FDA has also accepted the company's submission for diabetic retinopathy.
- Faricimab will be the first and only bispecific antibody designed for the eye if approved.
- It targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), which drive many retinal conditions that can cause vision loss.
- The European Medicines Agency has also validated the faricimab's application for nAMD and DME.
- Price Action: RHHBY shares closed at $47.64 on Wednesday.
- Related content: Benzinga's Full FDA Calendar.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in
