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BLUE

Bluebird Bio

$120.00

-0.52 (-0.43%)

09:30
06/03/19
06/03
09:30
06/03/19
09:30

Bluebird Bio announces EU conditional marketing authorization for ZYNTEGLO

bluebird bio announced that the European Commission has granted conditional marketing authorization for ZYNTEGLO, a gene therapy for patients 12 years and older with transfusion-dependent beta-thalassemia who do not have a beta0/beta0 genotype, for whom hematopoietic stem cell transplantation is appropriate but a human leukocyte antigen-matched related HSC donor is not available. bluebird bio will continue the country-by-country reimbursement process to help ensure access to ZYNTEGLO for appropriate patients. TDT is a severe genetic disease caused by mutations in the beta-globin gene that result in reduced or absent hemoglobin. In order to survive, people with TDT maintain hemoglobin levels through lifelong chronic blood transfusions. These transfusions carry the risk of progressive multi-organ damage due to unavoidable iron overload. ZYNTEGLO is a one-time gene therapy that addresses the underlying genetic cause of TDT and offers patients 12 years and older who do not have a beta0/beta0 genotype the potential to become transfusion independent, which once achieved is expected to be life-long. ZYNTEGLO was reviewed as part of the European Medicines Agency's Priority Medicines and Adaptive Pathways programs, which support medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options.

  • 04

    Jun

  • 06

    Jun

BLUE Bluebird Bio
$120.00

-0.52 (-0.43%)

05/15/19
WEDB
05/15/19
DOWNGRADE
WEDB
Neutral
Bluebird Bio downgraded to Neutral from Outperform at Wedbush
05/15/19
05/15/19
DOWNGRADE
Target $131

Neutral
Bluebird Bio downgraded to Neutral at Wedbush on ZYNTEGLO launch risks
As previously reported, Wedbush analyst David Nierengarten downgraded Bluebird Bio to Neutral from Outperform after attending the company's Analyst Day, as he sees risks to the ZYNTEGLO launch that could overshadow its broad pipeline. Specifically, the analyst now expects installment, performance-based pricing of $320,000/year, in-line with annual treatment costs, for 5 years, or $1.6M total, with a 15% discount on the total potential price as some patients will not fully respond/meet the performance requirements. With installment pricing, Nierengarten incorporates additional financing in his model as it creates an "air gap" for cash flow that the company will have to fill before it becomes cash flow positive. The analyst also lowered his price target on the shares to $131 fr0m $166.
05/16/19
RHCO
05/16/19
NO CHANGE
Target $174
RHCO
Buy
Bluebird Bio price target lowered to $174 from $184 at SunTrust
SunTrust analyst Edward Nash lowered his price target on Bluebird Bio to $174 to reflect the changes in his model after the company's Analyst Day presentation. The analyst is pushing back his expected Lenti-D start year to 2020 from 2019 and also raising his assumed R&D and SG&A expenses while also removing the revenue projections for the company's B-thalassemia patients aged below 12 in the U.S. and E.U. Nash is also keeping his Buy rating on Bluebird Bio, saying he sees the company as "best positioned" in transforming gene therapy from a "scientific endeavor" to a "successful proposition."
05/17/19
JPMS
05/17/19
NO CHANGE
Target $195
JPMS
Overweight
Bluebird Bio 20% pullback since early April brings opportunity, says JPMorgan
JPMorgan analyst Cory Kasimov thinks investors should use times of share weakness to buy or add to longer-term positions in Bluebird Bio. With the stock off nearly 20% since early April, "this could be one of those times," Kasimov tells investors in a research note. He believes Bluebird has a relatively high likelihood of going four-for-four with its initial late-stage shots on goal. The analyst maintains an Overweight rating on the shares with a $195 price target.

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