bluebird bio Inc (NASDAQ:BLUE) announced that theEuropean Medicines Agency (EMA) has granted access to its Priority Medicines (PRIME) scheme for LentiGlobin drug product in the treatment of patients with transfusion-dependent beta-thalassemia (TDT).
The PRIME initiative provides enhanced support and increased interaction to companies, with the goal of optimizing development plans and speeding regulatory evaluations to potentially bring innovative medicines to patients more quickly. To be accepted for PRIME, a therapy must demonstrate potential to benefit patients with unmet medical need through early clinical data or nonclinical data. Access to the PRIME initiative complements bluebird’s ongoing participation in the EMA’s Adaptive Pathways Pilot program, which also aims to expedite patient access to therapies with the potential to treat serious conditions with unmet need. It uses the existing EU regulatory framework for medicines, including conditional approval.
“PRIME designation will allow bluebird bio to further improve our communication with European regulators as we continue to refine our evidence generation plan in the context of adaptive biomedical innovation. Overall, we believe this will enable us to accelerate development of LentiGlobin drug product for patients with transfusion-dependent beta thalassemia, a life-shortening disease with significant unmet medical need,” said David Davidson, M.D., chief medical officer, bluebird bio. “Earlier this year we completed enrollment in the Northstar (HGB-204) global clinical study of LentiGlobin drug product in patients with TDT, which along with the supporting HGB-205 study, will form the basis of our eventual application for conditional approval in the EU under the Adaptive Pathways Pilot program. As the data from both studies mature, we look forward to continuing to work with the EMA to bring LentiGlobin to patients who may benefit from gene therapy.” (Original Source)
Shares of Bluebird are currently trading at $74.44, up $0.67 or 0.91%. BLUE has a 1-year high of $120.50 and a 1-year low of $35.37. The stock’s 50-day moving average is $56.49 and its 200-day moving average is $47.92.
On the ratings front, BLUE stock has been the subject of a number of recent research reports. In a report issued on September 13, BTIG analyst Dane Leone reiterated a Buy rating on BLUE, with a price target of $72, which represents a slight downside potential from current levels. Separately, on September 9, Maxim’s Jason McCarthy reiterated a Buy rating on the stock and has a price target of $85.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Dane Leone and Jason McCarthy have a total average return of 12.5% and 1.4% respectively. Leone has a success rate of 73% and is ranked #118 out of 4172 analysts, while McCarthy has a success rate of 41.5% and is ranked #1609.
Overall, one research analyst has assigned a Hold rating and 7 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $103.50 which is 40.3% above where the stock closed yesterday.
bluebird bio, Inc. is a clinical-stage biotechnology company. The company develops next generation products based on the transformative potential of gene therapy to treat patients with severe genetic and orphan diseases. It has two clinical-stage programs in development for childhood cerebral adrenoleukodystrophy and beta-thalassemia/sickle cell disease and a preclinical oncology program in the chimeric antigen receptor T cells field.