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BLUE

bluebird bio

$65.55

-4.48 (-6.40%)

08:03
10/13/16
10/13
08:03
10/13/16
08:03

bluebird bio says achieved general agreement on regulatory path for TDT

bluebird bio announced it will outline today key activities underway intended to advance the company's LentiGlobin programs in transfusion-dependent beta-thalassemia, or TDT, and severe sickle cell disease, or SCD. The presentation will focus on three key aspects of these activities: 1) potential improvements in transduction efficiency and manufacturing; 2) updates to the protocol for the company's ongoing HGB-206 clinical trial in SCD; and 3) regulatory plans for the company's LentiGlobin drug product candidate in TDT. bluebird bio is working closely with regulatory agencies in the United States and Europe to bring LentiGlobin to patients with TDT who can benefit, as quickly as possible, and has reached general agreement with the U.S. FDA and the European Medicines Agency, respectively, on the regulatory paths forward, the company said. "At bluebird bio we have an incredibly ambitious goal: to deliver one-time, transformative therapies to patients with rare genetic diseases and cancer. We are relentless in our efforts to continue innovating in pursuit of that goal, and we have made substantial advances in the transduction and manufacturing processes, translational research, and clinical development. By incorporating manufacturing Process 2 into our LentiGlobin clinical trials, we believe we can achieve our ultimate goal of increasing hemoglobin production in patients treated with LentiGlobin drug product. In sickle cell disease we have used our early clinical data to identify and implement multiple distinct improvements with the potential to overcome the unique challenges presented by this complex disease. We are hopeful that the tremendous work done by our research and development teams will yield improved outcomes for patients in the clinic in 2017 and beyond, and that the regulatory progress we are making will enable us to bring these treatments to patients as quickly as possible. We anticipate seeing many catalysts across our programs in the next 15 months, including initial clinical data from our Phase 1 clinical study of our bb2121 product candidate in relapsed/refractory multiple myeloma and updates on our Lenti-D program in cerebral adrenoleukodystrophy," said bluebird CEO Nick Leschly.

  • 13

    Oct

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    Nov

BLUE bluebird bio
$65.55

-4.48 (-6.40%)

09/15/16
09/15/16
UPGRADE

On The Fly: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Transocean (RIG) upgraded to Hold from Sell at Canaccord with analyst Alex Brooks citing valuation. 2. Dick's Sporting (DKS) upgraded to Outperform from Perform at Oppenheimer analyst Brian Nagel citing the potential for better near-term sales trends as "weaker players" in sporting goods retail fail. 3. Akorn (AKRX) upgraded to Overweight from Neutral at Piper Jaffray with analyst David Amsellem saying volume trends across the company's commercial portfolio suggests the base business is "on sustainable footing." 4. Petrobras (PBR) upgraded to Neutral from Underperform at Macquarie with analyst Giacomo Romeo saying near-term liquidity is less concerning after recent divestitures, an improved political outlook, and the re-gained access to the bond market. 5. bluebird bio (BLUE) upgraded to Conviction Buy from Buy at Goldman with analyst Salveen Richter saying he expects Gen2 data versus Gen1 data at the October 13 R&D day to show substantial efficacy improvements, which is underappreciated by the Street, a full LentiGlobin update at ASH scheduled for December 3-6, the unveiling of the CAR T/gene editing programs, and two pivotal readouts in mid-17 that will result in a transition to commercial focus. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
09/22/16
ROTH
09/22/16
INITIATION
Target $87
ROTH
Buy
bluebird bio reinstated with a Buy at Roth Capital
Roth Capital analyst Mark Breidenbach assumed coverage of bluebird bio with a Buy rating and $87 price target based on a sum-of-parts, probability-adjusted NPV analysis of the company's pipeline. The analyst believes bluebird bio can no longer be considered a fledgling given the clinical success seen in its Lenti-D and Lentiglobin programs, both hatched from the company's versatile core lentiviral technology platform.
09/22/16
09/22/16
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: Packaging Corp. (PKG) initiated with a Sell at Goldman. 2. Netlist (NLST) initiated with a Buy at B. Riley. 3. Weyerhaeuser (WY) initiated with a Conviction Buy at Goldman. 4. bluebird bio (BLUE) reinstated with a Buy at Roth Capital. 5. Dentsply Sirona (XRAY) initiated with a Neutral at JPMorgan. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
10/07/16
GSCO
10/07/16
NO CHANGE
GSCO
Smid-cap Biotech sector upgraded to Attractive from Neutral at Goldman
Goldman analyst Salveen Richter upgraded the Smid-cap biotechnology to Attractive and said he favors and companies with near-term pipeline data or regulatory events where he has conviction.Names he recommends are Buy rated BioMarin (BMRN), bluebird bio (BLUE), GW Pharma (GWPH), Incyte (INCY), Kite (KITE), and Sage (SAGE).

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