JPMorgan Reiterates Overweight On Bluebird Bio, Says It's 'Still Streaking'

In a report published Tuesday, JP Morgan analysts reiterated their Overweight rating on bluebird bio, Inc. BLUE, following the announcement of regulatory plans by the company for LentiGlobin in B-thalassemia in the US and the EU. The company intends to pursue accelerated approval in both regions, which could help the drug being launched earlier than the expected 2019 launch, especially in the EU because no new trials are needed for approval in this region. "We are encouraged by the seeming support from regulators," the analysts said, while adding, "With regulatory paths now clear, focus on pricing is likely to increase, which remains a key modeling lever." The next update for the program is expected in June. The accelerated approval in the US will be based on two new trials, HGB-207 and HGB-208, with 15 patients being enrolled for each and lasting for 24 months, where the primary endpoint of transfusion independence will be established at 12 months. Confirmatory data to convert the approval into full approval will be based on longer-term follow up study of these two trials. The two ongoing trials, HGB-204 and HGB-205, will be the basis for the conditional approval in the EU for both adults and adolescents. Conversion to full approval in the EU will be based on the success of the HGB-207 and HGB-208 trials, along with post-approval monitoring and long-term follow up data.