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Stock Market & Financial Investment News

News Breaks
June 17, 2014
09:25 EDTBLUE, BLUE, CELG, CELG, NVS, NVSPiper Jaffray biopharm analyst holds an analyst/industry conference call
Biopharmaceuticals Analyst Schimmer reviews major CAR-T programs in development, explains fundamentals of CAR-T and TCR-T and compares clinical data of CAR-T trials on an Analyst/Industry conference call. Relevant companies BLUE, CELG and NVS may be included on the Analyst/Industry conference call to be held on June 19 at 10 am.
News For BLUE;CELG;NVS From The Last 14 Days
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December 9, 2014
09:27 EDTBLUEbluebird bio price target raised to $90 from $50 at Roth Capital
Roth Capital hiked its price target on bluebird after the company reported favorable data for its LentiGlobin drug product at ASH. The firm keeps a Buy rating on the shares.
09:21 EDTBLUEOn The Fly: Pre-market Movers
UP AFTER EARNINGS: AutoZone (AZO), up 3.8%... Burlington Stores (BURL), up 3.3%. ALSO HIGHER: bluebird bio (BLUE), up 56.5% after price target raised at Piper Jaffray and SunTrust... Camtek (CAMT), up 6.7% after being awarded a $2.8M order from a semiconductor manufacturer... PDC Energy (PDCE), up 5.8% after providing fiscal 2015 production guidance... Mast Therapeutics (MSTX), up 3.1% after reporting that it will begin recruiting patients for MST-188 study in first half of fiscal 2015... Idera Pharmaceuticals (IDRA), up 1.4% after announcing data for its lead product candidate, IMO-8400. DOWN AFTER EARNINGS: UTi Worldwide (UTIW), down 10.8%... CONN'S (CONN), down 35.9% after reporting third quarter results, withdrawing fiscal 2015 guidance, stating that there is no timetable set for completion of strategic alternatives, and announcing the departure of its CFO. ALSO LOWER: Apple (AAPL), down 1.6% after Pacific Crest says that weak iPad demand could cause Apple to miss estimates and following a Wall Street Journal report that a judge denied Apple's efforts to throw out iPod pricing lawsuit... Allied Nevada Gold (ANV), down 30.1% after announcing pricing of common stock and warrant offering... United Continental (UAL), down 2.7% after reporting November traffic.
08:34 EDTCELGCelgene price target raised to $130 from $102 at Argus
Argus hiked its price target on Celgene as the firm thinks the company posted solid Q3 results, while it is continuing to make progress in its pipeline. Argus keeps a Buy rating on the shares.
08:28 EDTCELGCelgene price target raised to $130 from $112 at UBS
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07:44 EDTCELGAmerican Association for Cancer Research to hold a symposium
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07:35 EDTBLUEbluebird bio price target raised to $115 from $57 at SunTrust
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06:45 EDTBLUEbluebird bio price target raised to $112 from $52 at Piper Jaffray
Piper Jaffray more than doubled its price target for bluebird bio shares to $112 saying the company's LentiGlobin program is advancing in sickle cell anemia. Piper believes bluebird "remains positioned for extraordinary outperformance in 2015." The firm thinks the data presented at the American Society of Hematology are an "impressive accomplishment for the gene therapy field" as well as bluebird's lentivirus platform. It keeps an Overweight rating on the stock. Shares of the clinical-stage biotechnology company rallied yesterday $4.18 to $48.89 and are indicated up $21.11 in pre-market trading to $70.
05:46 EDTCELGCelgene presents POMALYST/IMNOVID Phase IIIb study results at ASH meeting
Celgene announced that results from the STRATUS trial, a single-arm phase IIIb study of pomalidomide plus low-dose dexamethasone in patients with relapsed and refractory multiple myeloma were presented at the 56th American Society of Hematology annual meeting. Pomalidomide is marketed as POMALYST in the United States and IMNOVID in the European Union. In the study, 599 patients with refractory, or relapsed and refractory, disease who had previously failed lenalidomide and bortezomib had been enrolled at the time of the data cutoff. The primary endpoint was safety, and key secondary endpoints included pomalidomide exposure, overall response rate, or ORR, duration of response, or DOR, progression-free survival, or PFS, overall survival, or OS, and cytogenetic analyses. Patients had a median five prior therapies. All patients received thromboprophylaxis with low-dose aspirin, low-molecular-weight heparin, or equivalent. At a median follow-up of 6.8 months with a median four cycles received, the median PFS and OS were 4.2 months and 11.9 months, respectively. The ORR was 35%, with 8% of patients achieving at least a very good partial response, or VGPR. The median DOR was 6.8 months. In patients refractory to prior lenalidomide or lenalidomide and bortezomib, similar PFS, OS, and ORR were achieved.
05:22 EDTCELGCelgene reports REVLIMID study data suggests improved response rates, PFS, OS
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05:17 EDTCELGCelgene reports Vidaza Phase III study shows doubled overall survival times
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December 8, 2014
17:48 EDTBLUEbluebird bio says first four patients treated with LentiGlobin transfusion-free
bluebird bio announced data from eight subjects treated with LentiGlobin BB305 drug product. In the first four subjects, each of whom had at least three months of follow up, treatment with LentiGlobin BB305 drug product resulted in sufficient hemoglobin production to reduce or eliminate the need for transfusion support among patients with beta-thalassemia major who would otherwise require chronic blood transfusions. These data include the first five subjects treated in bluebird bio’s ongoing Phase 1/2 Northstar Study and the first three subjects from its HGB-205 study. These studies include the first subjects with the beta-0/beta-0 genotype of beta-thalassemia major treated with LentiGlobin BB305 drug product and the first subject with sickle cell disease treated with gene therapy. These data are being presented today at the 56th Annual Meeting of the American Society of Hematology in San Francisco.
14:06 EDTCELGCelgene reports luspatercept, sotatercept increased hemoglobin levels in trials
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13:54 EDTCELGCelgene announces results from phase lll Revlimid study
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13:07 EDTNVSNovartis announces data from Jakavi trial
Novartis (NVS) announced data from the largest clinical trial of myelofibrosis patients treated with Jakavi, supporting the safety profile and efficacy benefit as measured in primary and secondary endpoints respectively. In an analysis of 1,144 patients treated with Jakavi to date in this ongoing expanded access study, 69% of patients achieved >50% reduction in spleen size from baseline and patients also experienced a clinically meaningful improvement in myelofibrosis symptom score, important treatment goals for patients with myelofibrosis. Findings from the study were presented at the 56th Annual Meeting of the American Society of Hematology in San Francisco, California. Novartis research and development efforts, in collaboration with Incyte Corporation (INCY), include early-phase and post-marketing studies in myelofibrosis and other myeloproliferative neoplasms. More than 50 abstracts on ruxolitinib are being presented at ASH, including three oral presentations exploring combinations of ruxolitinib with various investigational compounds, evaluating the possibility of simultaneously targeting multiple cancer pathways that may be involved in the pathogenesis of myelofibrosis. The JUMP study is a Phase IIIb, expanded-access trial for countries with no access to Jakavi outside of a clinical trial. The open-label, multicenter study analyzed 1,144 enrolled myelofibrosis patients who received daily starting doses of either 5 mg, 15 mg or 20 mg of Jakavi twice daily based on platelet counts at baseline. The primary endpoint is assessment of safety and tolerability of Jakavi. Overall, the safety and efficacy profile of Jakavi was consistent with previous studies.
13:05 EDTNVSNovartis reports six-year results from Phase III ENESTnd study
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11:30 EDTNVSLeerink generics pharmaceutical analyst holds analyst/industry conference call
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07:36 EDTCELGAgios announces Celgene to extend discovery phase of collaboration to April 2016
Agios Pharmaceuticals (AGIO) announced that Celgene (CELG) has elected to extend the period of its exclusivity for an additional year to April 2016 under the global strategic collaboration agreement. The two companies have been working together since April 2010 to discover, develop and commercialize disease-altering therapies in oncology arising from Agios' cancer metabolism research platform. The terms of the collaboration extension are consistent with previously agreed upon financial terms. As a result of the extension, Celgene will maintain its exclusive option to drug candidates that emerge from Agios' cancer metabolism research platform through April 2016. Agios will receive a $20M payment. Following this extension, the discovery portion of the collaboration will expire on April 14, 2016. Under the terms of the original agreement announced in April 2010, Agios leads research, preclinical and early development efforts through Phase 1, while Celgene receives an option to obtain exclusive rights either upon IND acceptance or at the end of Phase 1, to further development and commercialize medicines emerging from Agios' cancer metabolism research. Celgene would lead and fund global development and commercialization of some of these drugs, and Agios would retain development and commercialization rights for certain drugs in the United States. On all programs, Agios is eligible to receive up to $120M in milestone-based payments as well as royalties on any sales.
07:17 EDTCELGCelgene price target raised to $131 from $120 at Cantor
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05:42 EDTNVSSandoz Phase III data shows filgrastim has similar safety, efficacy as NEUPOGEN
Sandoz, a Novartis (NVS) company, announced Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen's (AMGN) NEUPOGEN in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also showed that repeated switching at each cycle between the investigational biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity. The PIONEER study was a Phase III study designed to compare the efficacy and safety of the investigational biosimilar and the reference product with respect to mean duration of severe neutropenia following Cycle 1 chemotherapy. PIONEER was a randomized, double-blind, four-group, multi-center non-inferiority trial conducted at 27 centers. The trial randomized 218 breast cancer patients receiving neoadjuvant myelosuppressive chemotherapy.
05:35 EDTCELGCelgene REVLIMID, low-dose dexamethasone increased PFS
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