Bluebird Bio Inc (BLUE)

[stocksrising]

Not sure of the Answers (questions asked), However it is un-typical of FDA to make a decision prior to published PDUFA date and this was surprise to even Morgan Stanley( increased price target- Upgrades Bluebird Bio to Equalweight From Underweight, Boosts Price Target to $7 From $3) on same day as approval…looks like today BLUE Pr’d updated Safety and stressed that the deaths/ side affects were from earlier versions:

Safety results summary

The majority of adverse events in patients treated in HGB-206 Group C and HGB-210 were attributed to underlying sickle cell disease or conditioning with busulfan. Nonserious adverse events related to lovo-cel included infusion reactions (abdominal discomfort, decreased diastolic blood pressure, and nasal congestion) each in one patient (2.1% each). Serious adverse events related to lovo-cel were reported in two patients with comorbid alpha-thalassemia trait and they included two SAEs each of Anemia (4.3%) and 1 SAE of Myelodysplastic syndrome (2.1%), the diagnosis of which remains under evaluation. One patient died due to sudden cardiac death which was deemed unrelated to lovo-cel.

As previously reported, cases of acute myeloid leukemia were observed in two patients from the HGB-206 Group A cohort who were treated with an EARLIER VERSION of the therapy prior to enhancements to the treatment and manufacturing processes. Both patients died due to aforementioned leukemia.

No graft failure, replication-competent lentivirus or vector-mediated insertional oncogenesis was observed across the entire clinical development program.