- Akebia Therapeutics Inc AKBA and its collaborator Otsuka Holdings OTSKY have announced that the FDA has accepted to review vadadustat's marketing application for anemia due to chronic kidney disease.
- The application covers both adult patients, on dialysis and not on dialysis.
- The agency's target action date is March 29, 2022.
- The FDA also indicated that they are not currently planning to hold an Advisory Committee meeting to discuss the application.
- In addition, Otsuka is working with Akebia to prepare a Marketing Authorization Application for vadadustat for submission to the European Medicines Agency expected in 2021.
- Price Action: AKBA shares are up 8.28% at $3.80 during the premarket session on the last check Tuesday.
© 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
