bluebird bio, Inc.NASDAQ
Fri, Oct. 21, 7:46 AM
- Almost Family (NASDAQ:AFAM) upgraded to Outperform from Sector Perform with a $55 (31% upside) price target by RBC Capital.
- Walgreens Boots Alliance (NASDAQ:WBA) upgraded to Buy from Hold by Jefferies. Price target raised to $95 (17% upside) from $87.
- Arbutus Biopharma (NASDAQ:ABUS) upgraded to Neutral from Sell with a $3 price (0% upside) target by Chardan Capital.
- Quintiles IMS Holdings (NYSE:Q) downgraded to Hold from Buy with a $79 (6% upside) price target by Jefferies.
- Anthem (NYSE:ANTM) downgraded to Neutral from Overweight by JPMorgan. Price target lowered to $132 (6% upside) from $154.
- Bluebird bio (NASDAQ:BLUE) downgraded to Sell from Hold by Cantor Fitzgerald. Price target lowered to $37 (32% downside risk) from $42.
- Henry Schein (NASDAQ:HSIC) downgraded to Neutral from Buy by Baird. Price target lowered to $164 (7% upside) from $176.
Fri, Oct. 14, 12:45 PM
Fri, Oct. 14, 11:20 AM
Fri, Oct. 14, 8:38 AM
- Cantor downgrades bluebird bio (NASDAQ:BLUE) to Sell from Hold.
- At an Investor/Analyst event yesterday, BLUE disclosed yesterday that all future LentiGlobin trials going forward will use its improved manufacturing process, and those trials are just beginning. Initial data may not become available until 2018. Meanwhile, the stock has rallied over the last couple of months in anticipation of the ASH conference in December.
- Drops price target to $37 from $42.
- See the full note here »
- Meanwhile, Leerink boosted its PT on BLUE ot $80 from $67, citing LentiGlobin improvements and what it sees as increased chances of success in more difficult to treat patients.
- See the full note here »
- Shares -2% premarket to $63.90.
Thu, Oct. 13, 11:16 AM
- In an investor update, bluebird bio (BLUE +1%) announces that its new LentiGlobin manufacturing process (Process 2), based on the addition of two transduction enhancers, produces an average three-fold increase in vector-positive cells and vector copy number (VCN) compared to its original process (Process 1). The company says Process 2 has been successfully scaled up for clinical manufacturing and all LentiGlobin clinical studies will rely on the new process going forward.
- In addition, bluebird intends to amend the protocol to its ongoing late-stage study, HGB-206, aimed at improving patient outcomes. Specifically: improve stem cell collection via better cell separation techniques and a higher minimum cell dose and the suppression of sickle cell bone marrow pathology through pre-stem cell harvest red blood cell transfusions; increase the percentage of cells transduced and VCN via the implementation of Process 2; enhance the engraftment of LentiGlobin by adjusting the target level of exposure to busulfan for pre-infusion conditioning and explore alternative cell collection techniques through the mobilization and apheresis of patient CD34+ cells using plerixafor. The study, in patients with beta thalassemia or severe sickle cell disease, is expected to be completed in March 2031 (15 years of post-infusion follow-up), although the parent study will run ~two years.
Thu, Sep. 29, 7:07 AM
- Medigene AG (OTCPK:MDGEF) and bluebird bio (NASDAQ:BLUE) ink a strategic R&D collaboration and license agreement encompassing T cell receptor (TCR) immunotherapies against four targets.
- Under the terms of the agreement, Medigene will generate and deliver the TCRs using its TCR isolation and characterization platform. Following the collaborative preclinical development, bluebird will take over clinical development and commercialization of the TCR candidates and will receive an exclusive license for the relevant intellectual property.
- Medigene will receive an upfront payment of $15M, up to $1B in milestones for the four candidates across several indications, R&D funding and up to double-digit tiered royalties on net sales.
- Medigene will host a conference call at 9:00 am ET to discuss the deal.
Thu, Sep. 22, 10:45 AM
- Buoyed in large part by the FDA's approval of Sarepta Therapeutics' (SRPT +4.4%) Exondys 51 for Duchenne muscular dystrophy and Allergan's (AGN +1.9%) over-the-top acquisition of NASH player Tobira Therapeutics (TBRA +0.6%), money flow has turned decidedly bullish for biotechs. On a technical basis, the iShares Nasdaq Biotechnology ETF (IBB +0.6%) is poised for a breakout through 300, a healthy 25% turnaround from the low of ~240 in June.
- There is a laundry list of leaders in the rally, including bluebird bio (BLUE -0.1%), Clovis Oncology (CLVS +5.4%), Puma Biotechnololgy (PBYI +3.8%), Aerie Pharmaceuticals (AERI -2.1%) and CoLucid Pharmaceuticals (CLCD -3.7%).
Wed, Sep. 21, 9:19 AM
- The European Medicines Agency (EMA) grants access to its Priority Medicines (PRIME) scheme for bluebird bio's (NASDAQ:BLUE) LentiGlobin BB305 gene therapy for the treatment of transfusion-dependent beta thalassemia, an inherited blood disorder characterized by the lack of oxygen in many parts of the body due to an abnormally low level of hemoglobin.
- LentiGlobin BB305 is currently in Phase 3 development for the indication. According to ClinicalTrials.gov, the estimated completion date of the 15-subject study is January 2020.
- PRIME, akin to the FDA's Breakthrough Therapy designation, provides for enhanced support from the EMA including increased interaction with the company. The aim is to provide quicker patient access by optimizing the drug development plan and speeding up the regulatory review process.
- Shares are up 2% premarket on light volume.
Thu, Sep. 8, 9:23 AM
Thu, Sep. 8, 8:57 AM
- Bluebird bio (NASDAQ:BLUE) perks up 6% premarket on light volume in response to its announcement that it has launched a Phase 3 clinical trial, HGB-207, in patients with transfusion-dependent beta thalassemia with certain genotypes (non-beta0/beta0). In this particular study, the process by which the patient's cells are transduced (converted) with LentiGlobin will be modified by the addition of two additives during the transduction step in the hematopoietic stem cell manufacturing process. The objective is to increase vector copy number and increase the percentage of cells successfully transduced.
- The target enrollment in HGB-207 is 15 subjects. The primary endpoint is transfusion independence defined as a 12-month transfusion-free period after transplant.
- The company intends to incorporate these additives, called transduction enhancers, into its ongoing study, HGB-206, assessing LentiGlobin in patients with severe sickle cell disease.
Wed, Aug. 3, 5:11 PM
Wed, Jul. 13, 9:26 AM
- The unexpected quick reversal of fortune of Juno Therapeutics (NASDAQ:JUNO) Phase 2 study of JCAR015 (the trial can resume sans preconditioning with fludarabine) gooses the money flow into other CAR-T developers.
- In premarket action: Kite Pharma (NASDAQ:KITE) up 7%, Cellectis (NASDAQ:CLLS) up 7%, bluebird bio (NASDAQ:BLUE) up 2%.
- JUNO is up 24% premarket on robust volume.
- Previously: FDA OKs resumption of Juno's mid-stage study of JCAR015; shares up 28% after hours (July 12)
Fri, Jun. 3, 8:01 AM
- GW Pharmaceuticals (NASDAQ:GWPH) initiated with Buy rating and $181 (87% upside) price target by Cantor Fitzgerald.
- Bluebird bio (NASDAQ:BLUE) initiated with Hold rating and $42 (13% downside risk) price target by Cantor Fitzgerald.
- Kite Pharma (NASDAQ:KITE) initiated with Outperform rating and $61 (11% upside) price target by Raymond James.
- Spark Therapeutics (NASDAQ:ONCE) initiated with Hold rating and $58 (5% upside) price target by Jefferies.
- Zoetis (NYSE:ZTS) initiated with Buy rating and $58 (21% upside) price target by Stifel Nicolaus.
- Cardiome Pharma (NASDAQ:CRME) initiated with Buy rating and $9.50 (87% upside) price target by H.C. Wainwright.
- Premier (NASDAQ:PINC) initiated with Overweight rating and $41 (24% upside) price target by Barclays.
- Gilead Sciences (NASDAQ:GILD) initiated with Buy rating and $109 (25% upside) price target by Gabelli & Co.
- Intellia Therapeutics (NASDAQ:NTLA) initiated with Outperform rating and $39 (39% upside) price target by Credit Suisse.
Wed, May 4, 5:19 PM
- bluebird bio (NASDAQ:BLUE): Q1 EPS of -$1.52 misses by $0.29.
- Revenue of $1.5M (-76.3% Y/Y) misses by $2.73M.
Wed, Apr. 20, 12:45 PM
Wed, Apr. 20, 12:05 PM
- Investors appear to lack enthusiasm over interim data released today by bluebird bio (BLUE -4.8%) from a Phase 2/3 clinical trial assessing gene therapy candidate, Lenti-D, in pediatric patients with cerebral adrenoleukodystrophy (CALD), a rare inherited disorder linked to the X chromosome characterized by the buildup of fats in the brain. The results are being presented today at the 68th Annual Meeting of the American Academy of Neurology in Vancouver, BC.
- The trial, called The Starbeam Study, has enrolled 17 boys up to the age of 17 with CALD. All have been treated with Lenti-D and have had at least six months of follow-up. Eight patients have had 12-24 months of follow-up. According to clinicaltrials.gov, the estimated study completion date is August 2018.
- The primary endpoint is the proportion of patients with no major functional disabilities (MFDs) at month 24 post treatment. MFDs are six components (e.g. loss of communication, cortical blindness, tube feeding) of a scoring system called neurological function score (NFS), that measures clinical deficits across 15 functional domains. The presence of any of the six represents a profound negative impact on patients' lives.
- The data show all 17 patients remain free of MFDs, with 16 experiencing stable NFS. 14 had stable Loes scores (measure of quantifying demyelination and atrophy in CALD patients using brain MRI). Lenti-D's safety profile was consistent with myeloablative (lowering of the number of blood-forming cells in the bone marrow) conditioning.
- Management will host a conference call today at 4:30 pm ET to discuss the results.