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News Breaks
April 7, 2014
09:10 EDTPFE, MAT, MNK, WWE, MNKD, P, QCOR, AGIO, AEO, VOCSOn The Fly: Pre-market Movers
HIGHER: Questcor (QCOR), up 27% after agreeing to be bought by Mallinckrodt (MNK) for cash, stock valued at $86.10 per Questcor share... Agios Pharmaceuticals (AGIO), up 25% after program shows "promising clinical activity" for advanced blood cancers, shares upgraded at JPMorgan... Vocus (VOCS), up 47% after agreeing to be acquired by GTCR for $446.5M, or $18.00 per share... Pandora (P), up 1.3% following upgrade at Wedbush. LOWER: MannKind (MNKD), down 13% after announcing FDA extension of PDUFA date for Afrezza... American Eagle (AEO), down 2.2% following downgrade at Cowen... Pfizer (PFE), down 2.8% after announcing data for palbociclib in metastatic breast cancer... Mattel (MAT), down 3% following downgrade at BMO Capital... WWE (WWE), down 1.2% after cautious mention in Barron's, company announcing WrestleMania 30 grossed $10.9M.
News For QCOR;MNK;VOCS;P;MAT;AEO;MNKD;PFE;AGIO;WWE From The Last 14 Days
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December 9, 2014
16:25 EDTAGIOAgios Pharmaceuticals files to sell $175M of common stock
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16:09 EDTAGIOAgios Pharmaceuticals files automatic mixed securities shelf
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14:22 EDTMNKAetna updates clinical policy for H.P. Acthar Gel
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12:22 EDTPFEPiper Jaffray biopharm analyst holds an analyst/industry conference call
Senior Research Analyst Schimmer, along with Biopharmaceuticals Analyst Breazzano, discuss gene therapy for hemophilia on an Analyst/Industry conference call to be held on December 11 at 10 am.
10:32 EDTPFEPfizer says in talks with FDA on path forward for Mylotarg
Pfizer announced the presentation of encouraging early- and late-stage data from clinical studies across several hematologic malignancies, including acute myeloid leukemia, acute lymphoblastic leukemia and chronic myeloid leukemia. Among the highlights are results from several investigator-led, large, randomized studies evaluating the antibody-drug conjugate MYLOTARG in select adult AML populations. Research was presented at the 56th Annual Meeting of the American Society of Hematology in San Francisco, December 6-9. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology, said “In particular, we are encouraged by the significant clinical evidence emerging from large randomized trials, such as AML-19 and ALFA-0701, demonstrating a positive impact of MYLOTARG when added to standard first-line treatment for patients with acute myeloid leukemia. We are engaging in discussions with the U.S. FDA and other health authorities to determine the best path forward for MYLOTARG. In addition, we plan to initiate an expanded access protocol for the therapy by the end of 2014 in the United States in patients with relapsed or refractory acute myeloid leukemia for whom there are no other treatment options.”
10:23 EDTAEOOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: American Eagle (AEO) upgraded to Outperform from Perform at Oppenheimer... Concho Resources (CXO) upgraded to Outperform from Neutral at Macquarie... Hanmi Financial (HAFC) upgraded to Outperform from Market Perform at FBR Capital... LHC Group (LHCG) upgraded to Outperform from Underperform at Credit Suisse... Lincoln Electric (LECO) upgraded to Buy from Neutral at Longbow... Northeast Utilities (NU) upgraded to Outperform from Neutral at Macquarie... SM Energy (SM) upgraded to Outperform from Neutral at Macquarie... Volcano (VOLC) upgraded at Needham... Wells Fargo sees fewer distractions for lululemon (LULU), upgrades shares... Xcel Energy (XEL) upgraded to Outperform from Neutral at Macquarie... lululemon (LULU) upgraded to Outperform from Market Perform at Wells Fargo.
07:44 EDTPFEAmerican Association for Cancer Research to hold a symposium
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07:32 EDTWWEUBS to hold a conference
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07:22 EDTPBMO Capital to hold a conference
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05:56 EDTAEOAmerican Eagle upgraded to Outperform from Perform at Oppenheimer
Oppenheimer upgraded American Eagle to Outperform with a $14 price target.
December 8, 2014
13:32 EDTPFEPfizer, Bristol-Myers announce results of human study on Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced results of the first human study evaluating the reversal of the anticoagulant effect of Eliquis by 4-factor prothrombin complex concentrates in healthy subjects. The study results demonstrated that both PCCs, Sanquin’s Cofact and CSL Behring’s Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis in several coagulation assessments, including endogenous thrombin potential. The full data will be presented today during the Antithrombotic Therapy: Anticoagulant Therapy session at the 56th annual meeting of the American Society of Hematology in San Francisco, CA. The study was an open label, randomized, placebo-controlled, three-period crossover study in 15 healthy, adult subjects. Within each period, subjects received Eliquis 10 mg twice daily. On day four, three hours after Eliquis administration, subjects received a 30-minute infusion of 4-factor PCCs, either 50 IU/kg Cofact or Beriplex P/N, or an equivalent volume of saline solution. The effect of Cofact and Beriplex P/N on the pharmacodynamics of Eliquis was based upon changes in endogenous thrombin potential, a measure of thrombin-mediated coagulation. Treatment periods were separated by an 11-day washout, after which the alternate treatment was administered. In this study, no serious adverse events, bleeding-related events or signs of thrombosis were reported with Eliquis administration with or without PCC treatment. Overall, these data demonstrate that Cofact and Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis as measured by ETP and support further evaluation of PCCs in the management of patients treated with Eliquis who require reversal of its anticoagulant effect.
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.
10:46 EDTPPandora calls active on renewed takeover speculation
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10:36 EDTPRumor: Pandora moves up on renewed takeover chatter
10:20 EDTAEOOptions with decreasing implied volatility
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09:20 EDTAGIOOn The Fly: Pre-market Movers
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08:03 EDTPFEPfizer announces agreement with Spark Therapeutics to develop SPK-FIX
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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.
05:50 EDTMNKDStocks with implied volatility movement; AVNR MNKD
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