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Bluebird app won't take pictures trial#
Puma Biotech's Neratinib Fails To Extend Overall Survival In Brain Cancer Trial Such icons and trademarks are referenced on this site for the purpose of identifying the apps, and their use does not mean that the owner of any such icons or trademarks is associated with and/or endorses this website or the research project. Mesoblast Announces Debt Refinancing And Expansion With Oaktree Capital Disclaimer: Any and all app-related icons or other trademarks appearing on this site are the property of their respective owners. Price Action: BLUE shares are up 10.30% at $11.75 during the premarket session on the last check Monday.Ĭlick here for options trades from Benzinga The FDA previously granted beti-cel Orphan Drug status and Breakthrough Therapy designation.Īlso See: Bluebird Bio To Withdraw Marketing Of Skysona Gene Therapy In Europe. Together, these studies represent more than 220 patient-years of experience with beti-cel. The application is based on data from Phase 3 studies HGB-207 (Northstar-2) and HGB-212 (Northstar-3), the Phase 1/2 HGB-204 (Northstar) and HGB-205 studies, and the long-term follow-up study LTF-303. The agency has set a Prescription Drug User Fee Act goal date of May 20, 2022. If approved, beti-cel will be the first one-time treatment that addresses the underlying genetic cause of disease-offering an alternative to regular RBC transfusions and iron chelation therapy.
The agency has granted priority review for Beti-cel, gene therapy for β-thalassemia across all genotypes who require regular red blood cell transfusions. The FDA has accepted Bluebird bio Inc's (NASDAQ: BLUE) marketing application for betibeglogene autotemcel (beti-cel) for β-thalassemia.