bluebird outlines accelerated pathways for LentiGlobin BB305

bluebird bio Inc. (NASDAQ:BLUE) gained $14.13 to $170.53 on Tuesday after it said it reached "general agreement" with U.S. and EU regulatory agencies on pathways that could result in accelerated approval of its LentiGlobin BB305 gene therapy to treat beta thalassemia major.

The company will participate in EMA's adaptive pathways pilot project and seek conditional approval of LentiGlobin BB305 in adults and adolescents with beta thalassemia major based on data from the ongoing Phase I/II Northstar (HGB-204) trial and Phase I/II HGB-205 trial. bluebird's shares rose sharply in December after it reported interim data from the two trials (see BioCentury Extra, Dec. 9, 2014). ...