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June 12, 2014
04:55 EDTBLUE, BLUE, BLUE, BLUE, ACE, ACE, ACE, ACE, XLRN, XLRN, XLRN, XLRN, TGTX, TGTX, TGTX, TGTX, NVS, NVS, NVS, NVS, AGIO, AGIO, AGIO, AGIO, AG, AG, AG, AGEuropean Hematology Association to hold a conference
19th Congress of the European Hematology Association will be held in Milan, Italy on June 12-15.
News For BLUE;ACE;XLRN;TGTX;NVS;AGIO;AG From The Last 14 Days
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December 9, 2014
07:35 EDTBLUEbluebird bio price target raised to $115 from $57 at SunTrust
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06:54 EDTACEACE Limited initiated with a Neutral at JPMorgan
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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.
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.
16:24 EDTXLRNOn The Fly: Closing Wrap
Stocks on Wall Street were lower amid another drop in crude oil prices, which tumbled to five-year lows. The market opened slightly lower following weaker than expected data from China and Japan, with nothing of note on the domestic calendar to get buyers involved in the day’s activity. Near noon, the averages gained downside momentum and though the market pared its losses several times, it was never able to gain any steam to pull the indexes back into the green. ECONOMIC EVENTS: In the U.S., no major economic data was released. In Asia, Chinese exports rose 4.7% from a year earlier in November, which missed the consensus estimate for an 8% increase. Chinese imports fell 6.7% from the prior year last month, compared with projections for a 3.8% increase. Additionally, Japan's revised third quarter gross domestic product estimate showed the economy shrank more than initially thought, with growth contracting an annualized 1.9%. COMPANY NEWS: Shares of Cubist Pharmaceuticals (CBST) surged $26.24, or 35.29%, to $100.60 after Merck (MRK) agreed to acquire the maker of next-generation antibiotics for $102 per share in cash, or $8.4B and the assumption of $1.1B in debt. A number of other antibiotic makers also climbed, including Tetraphase (TTPH), which rose $2.45, or 8.82%, to $30.24, and Cempra (CEMP), which advanced $1.64, or 11.37%, to $16.06, while shares of Merck finished fractionally higher, adding 39c, or 0.63%, to $61.88 following the deal announcement. MAJOR MOVERS: Among the notable gainers following their presentations at the American Society of Hematology, or ASH, annual meeting were Calithera Biosciences (CALA), which gained $2.38, or 22.52%, to $12.95, and Acceleron Pharma (XLRN), which jumped $5.11, or 13.6%, to $42.67. Among the noteworthy losers was McDonald's (MCD), which fell $3.70, or 3.84%, to $92.61 after the Dow member reported a 2.2% decline in global same-restaurant sales in November. Additionally, the fast-food giant warned that its fourth quarter results would be hurt by its sales pressures, supplier issues in China and a stronger U.S. dollar. Also lower were shares of Liquidity Services (LQDT), which plunged $2.77, or 27.0%, to $7.49 after the company disclosed that Wal-Mart (WMT) had terminated a deal to provide it with surplus merchandise. INDEXES: The Dow fell 106.31, or 0.59%, to 17,852.48, the Nasdaq dropped 40.06, or 0.84%, to 4,740.69, and the S&P 500 slipped 15.06, or 0.73%, to 2,060.31.
14:06 EDTXLRNCelgene reports luspatercept, sotatercept increased hemoglobin levels in trials
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13:45 EDTTGTXTG Therapeutics says TG-1101 well tolerated in Phase 2 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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13:02 EDTAGIOAgios Pharmaceuticals says Phase 1 AG-348 trials met primary endpoints
Agios Pharmaceuticals presented the first clinical data from its Phase 1 single and multiple ascending dose clinical trials of AG-348 in healthy volunteers. These results provide early proof-of-mechanism for AG-348, a novel, first-in-class, oral activator of both wild type and mutated pyruvate kinase-R enzymes. In these Phase 1 studies, dosing of AG-348 over 14-days in healthy volunteers resulted in a dose-dependent increase in the pyruvate kinase-R pathway as evidenced by a substantial increase in ATP and decrease in 2,3-DPG levels, which are key biomarkers of PKR activity and primary indicators of PK deficiency. These data support the hypothesis that AG-348 treatment may similarly enhance PKR activity in patients with PK deficiency and thus correct the underlying defect of the disease. These results will be presented during a poster session at the 56th Annual Meeting of the American Society of Hematology. The results being reported are from 64 healthy volunteers who received either AG-348 or placebo, which includes 48 people from the completed SAD study and 16 people in the first two cohorts of the ongoing MAD study that recently completed enrollment. Complete safety results are being reported from the SAD Phase 1 study and showed that AG-348 was well tolerated. Although the MAD study remains blinded, no serious adverse events have been reported in the first two analyzed cohorts. AG-348 also showed a favorable pharmacokinetic profile with rapid absorption, low variability and dose-proportional increase in exposure following both single and multiple doses. The observed dose-dependent changes in 2,3-DPG and ATP blood levels seen are consistent with a substantial increase in PKR enzymatic activity. The Phase 1 studies are randomized, double blind, placebo-controlled trials evaluating single ascending and multiple ascending oral doses for 14 days. The primary objectives of the studies are to assess safety and tolerability of AG-348 in healthy subjects and identify a safe and pharmacodynamically active dose and schedule for future studies in patients with PK deficiency. Secondary objectives are designed to characterize the pharmacokinetics of AG-348 and the PK/PD relationship between AG-348, ATP, and 2,3-DPG. Both trials successfully met their respective primary endpoints.
11:30 EDTNVSLeerink generics pharmaceutical analyst holds analyst/industry conference call
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09:20 EDTAGIOOn The Fly: Pre-market Movers
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07:39 EDTAGIOAgios Pharmaceuticals volatility low into new data from Ongoing Phase 1 trial
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07:36 EDTAGIOAgios 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.
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.
December 7, 2014
16:40 EDTAGIOAgios announces new data from Ongoing Phase 1 trial of AG-221
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16:16 EDTTGTXTG Therapeutics announces results from Phase l study of TGR-1202
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14:14 EDTAGIOAgios Pharmaceuticals to hold a luncheon discussion
Investor Luncheon to review data presented at the American Society of Hematology's Annual Meeting is being held in San Francisco on December 8 at 3 pm. Webcast Link
14:10 EDTAGIO, XLRNAmerican Society of Hematology to hold a meeting
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13:16 EDTXLRNCelgene, Acceleron announced data from luspatercept phase 2 clinical trial
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