Bluebird bio down on delay filing LentiGlobin application for sickle cell

• Bluebird bio (NASDAQ:BLUE) slumps 15% premarket on light volume in apparent response to its announcement after the close yesterday related to the planned U.S. marketing application for its LentiGlobin gene therapy for sickle cell disease (SCD).
• It generally agrees with the FDA that the clinical data package supporting the application will be based a portion of patients in the Phase 1/2 HGB-206 study Group C. It also generally agrees with the agency on the transition path to commercial manufacturing using an analytical comparability strategy (a totality of evidence approach), including suspension-based lentiviral vector (the vector is produced in suspension using serum-free media in order to scale up more easily).
• The company says these developments de-risk the program but the FDA wants to see comparability between drug product made from SCD patient cells and healthy donors as well as commercial lentiviral vector. These requirements, in addition to COVID-19 disruptions, will delay the filing of its U.S. marketing application to late 2022.
• https://seekingalpha.com/news/3632183-bluebird-bio-down-15-on-delay-in-filing-lentiglobin-application-for-sickle-cell