bluebird bio, Inc.NASDAQ
Wed, Dec. 7, 8:53 AM
- Bluebird bio (NASDAQ:BLUE) eases 3% in premarket trading. After the close yesterday, the company announced a $250M stock offering at $76, a discount to the closing price of $78.95.
Wed, Dec. 7, 1:53 AM
- bluebird bio (NASDAQ:BLUE) prices a 3.3M share offering at $76/share.
- The offering was upsized to $250M from a previously disclosed $200M.
- Goldman Sachs, BofA Merrill Lynch and Cowen & Co. are joint book-running managers of the offering. Wells Fargo Securities and Wedbush PacGrow are co-managers.
- BLUE closed at $78.95.
Tue, Dec. 6, 5:14 PM
Tue, Dec. 6, 1:06 PM
- Interim results from bluebird bio's (BLUE +6.5%) Phase 1/2 Northstar (HGB-204) study assessing its LentiGlobin drug product in patients with transfusion-dependent beta thalassemia (TDT) showed a significant treatment benefit. The data are being presented at the 58th American Society of Hematology (ASH) annual meeting in San Diego.
- TDT patients with non-beta0/beta0 genotypes who have been followed for at least 12 months have stopped regular transfusions while patients with the beta0/beta0 genotypes have experienced a median reduction of 63% in transfusion volume.
- The company says the vector copy numbers for the first patients treated in studies HGB-207 and HGB-206 with its "new and improved" LentiGlobin (Process 2) are 2.8 and 3.3, respectively, supporting the company's rationale for revising the manufacturing process to increase yield.
Fri, Dec. 2, 8:36 AM
- Bluebird bio (NASDAQ:BLUE) announces two new appointments as part of the company’s ongoing preparation for commercial readiness. Susanna High has been named chief operating officer and Andrew Obenshain senior vice president and head of Europe.
- Prior to joining bluebird, Ms. High worked at Alnylam Pharmaceuticals responsible for company strategy, business planning and various other activities. She also worked at Millennium Pharmaceuticals (now Takeda Oncology).
- Previously, Mr. Obenshain served at Shire in Paris as General Manager of France and Benelux and at Sanofi Genzyme in management operations.
Thu, Dec. 1, 11:01 AM
Wed, Nov. 30, 6:54 PM
- Bluebird bio (NASDAQ:BLUE) is up 22% after hours on increased volume in response to its announcement of positive interim results from a Phase 1 study assessing CAR-T candidate bb2121 in patients with treatment-resistant multiple myeloma (MM). The data will be presented tomorrow at the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium in Munich, Germany.
- The objectives of the open-label study are safety and preliminary efficacy of ascending doses with the aim of identifying the recommended dose for subsequent trials. As of the November 18th data cutoff, 11 heavily pretreated patients had been enrolled and dosed in four cohorts: 5.0 x 10(7), 15.0 x 10(7), 45.0 x 10(7) and 80 x 10(7) CAR+ T cells.
- The first nine patients (first three cohorts) were evaluable for safety and underwent their first MM restaging so they were evaluable for efficacy. All received a conditioning regimen of cyclophosphamide and fludarabine before receiving bb2121.
- The overall response rate in the nine patients was 78% and 100% in the second and third cohorts. Two patients achieved stringent complete responses with six and four months follow-up, respectively. All patients in the cohorts 2 and 3 with bone marrow involvement at baseline had no detectable MM cells in their bone marrow on day 14 or beyond.
- No dose-limiting toxicities were observed. No Grade 3 (serious) or Grade 4 (life-threatening) cytokine release syndrome or Grade 3 or 4 neurotoxicity was observed. No patients received steroids or tocilizumab (Roche's Actemra).
- The company intends to initiate the expansion cohort after the dose escalation phase is completed. According to ClinicalTrials.gov, the estimated study completion date is December 2018.
- Management will host a conference call and webcast tomorrow, December 1, at 8:00 am ET to discuss the data.
Wed, Nov. 23, 9:29 AM
Wed, Nov. 2, 5:11 PM
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%).