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Stock Market & Financial Investment News

News Breaks
April 7, 2014
12:15 EDTMNK, WWE, QCOR, VOCS, PFEOn The Fly: Midday Wrap
Stocks on Wall Street were lower at midday, resuming the sell-off that began in earnest Friday. With little on the economic calendar to change the momentum and earnings season on the cusp of kicking off but not yet began, the averages declined further. The losses near noon come on top of the 1% slide in the Dow and S&P seen Friday, and the pull back of over 2.5% notched by the Nasdaq in the final day of last week. ECONOMIC EVENTS: In the U.S., a report on the growth in consumer credit in February is expected at 3:00 pm ET. COMPANY NEWS: Shares of pharmaceutical giant Pfizer (PFE) slid over 3% after the company reported over the weekend that a trial on its palbociclib drug for breast cancer achieved its primary endpoint by significantly prolonging progression-free survival, but that an initial assessment of overall survival was not statistically significant. Research firm BMO Capital thinks the data was positive but could underwhelm investors. However, the firm agrees with Pfizer that a strong PFS benefit should enable the drug to be approved by the FDA and thinks that consensus estimates for the drug's long-term sales are conservative. MAJOR MOVERS: Among the notable gainers was cloud marketing software provider Vocus (VOCS), which surged 47% after agreeing to be acquired by an affiliate of private equity firm GTCR for $18 per share, or $446.5M. Also higher was short-seller target Questcor (QCOR), which jumped 12% after the company agreed to be bought by Mallinckrodt (MNK) for about $5.6B, made up of $30.00 per share in cash and 0.897 Mallinckrodt shares for each Questcor share owned. Questcor has been a frequent target of the short-selling blog Citron Research, which claimed as recently as March 14 that Questcor was "deceiving" the FDA and investors. Mallinckrodt shares were down over 8% near midday after announcing the deal, which will result in Mallinckrodt shareholders owning approximately 50.5% and former Questcor shareholders owning about 49.5% of the new combined company's stock. Also lower was World Wrestling Entertainment (WWE), which fell 20% after announcing that WWE Network has 667,287 subscribers 42 days after launching in the U.S. and that that WrestleMania 30 grossed $10.9M. The stock was also mentioned cautiously in Barron's magazine's "The Trader" column over the weekend. INDEXES: Near midday, the Dow was down 130.88, or 0.8%, to 16,281.83, the Nasdaq was down 47.17, or 1.14%, to 4,080.55, and the S&P 500 was down 16.17, or 0.87%, to 1,848.92.
News For PFE;QCOR;MNK;VOCS;WWE From The Last 14 Days
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December 19, 2014
07:42 EDTMNKEPAM, WisdomTree added to Franchise Pick list at Jefferies
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December 18, 2014
12:55 EDTPFECourt delays Teva's launch of generic Celebrex, Globes reports
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08:03 EDTPFEPfizer reports statistically significant results in Phase 3 pregabalin study
Pfizer announced top-line results from a double-blind Phase 3 study evaluating pregabalin controlled-release formulation in adult patients with postherpetic neuralgia. The results show that pregabalin CR resulted in a statistically significant positive effect compared to placebo in the primary endpoint, time to loss of therapeutic response in pain reduction. PHN is a type of peripheral neuropathic pain caused by nerve damage. Symptoms include continued burning or electric shock-like pain.1 This study is the final of three Phase 3 studies of the pregabalin CR formulation conducted to ascertain the potential use of pregabalin as a once-a-day therapy. The first study in adults with partial onset seizures with epilepsy did not meet its primary endpoint. In the second study in patients with fibromyalgia, pregabalin CR had a statistically significant positive effect compared to placebo in the primary endpoint, time to LTR in pain reduction. The objective of the Phase 3 double-blind, randomized, placebo-controlled study was to evaluate the safety and efficacy of pregabalin CR compared with placebo in the durability of effect for the treatment of pain associated with PHN among patients who initially respond to single-blind pregabalin.
07:28 EDTPFEPfizer shares poised to perform well in 2015, says Deutsche Bank
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December 17, 2014
08:01 EDTPFEPfizer initiates Phase 2 PF-06252616 study
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December 15, 2014
18:32 EDTPFEPfizer announces Palbociclib PALOMA-1 data published in The Lancet Oncology
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12:09 EDTPFEPfizer increases dividend 8% to 28c per share
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10:40 EDTPFEOPKO Health deal with Pfizer removes financing overhang, says Ladenburg
Ladenburg views the agreement OPKO Health (OPK) signed with Pfizer (PFE) as a significant positive catalyst since the company is partnering with an established leader in short-acting hGH and because the large upfront payment removes near-term financing needs as an overhang on the stock. The firm reiterates its Buy rating and $14.50 price target on OPKO, but said it will re-examine its projections after the deal closes.
10:19 EDTPFEOPKO Health soars after entering hGP-CTP agreement with Pfizer
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09:03 EDTPFEBaxter to divest Vero cell vaccines platform to Nanotherapeutics
Baxter International (BAX) announced that it has entered into a definitive agreement to sell its proprietary Vero cell technology and related assets, including its production facility in Bohumil, Czech Republic, to Nanotherapeutics, Inc. Financial details were not disclosed. The agreement with Nanotherapeutics includes all assets related to the platform, including vaccines for H5N1, H1N1 and seasonal influenza. The agreement also includes investigational vaccine programs for Ross River virus, Chikungunya disease and West Nile virus. In recent weeks, the company has also completed the sale of its commercial vaccines business and related manufacturing facilities to Pfizer (PFE).
08:02 EDTPFEPfizer, OPKO Health enter into global agreement for hGH-CTP
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December 10, 2014
08:31 EDTPFETeva announces launch of first generic Celebrex capsules in the U.S.
Teva Pharmaceutical Industries (TEVA) announces the launch of the first FDA-approved generic equivalent to Celebrex Capsules in the United States. Teva is offering 50, 100, 200, and 400 mg strengths of Celecoxib Capsules. Celebrex Capsules, marketed by Pfizer (PFE) had annual sales of approximately $2.56B in the United States, according to IMS data as of October 2014.
07:38 EDTPFEMylan launches generic version of Pfizer's Celebrex capsules
Mylan (MYL) announced the U.S. launch of its Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, one of the first available generic versions of Pfizer's (PFE) Celebrex Capsules, indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Celecoxib Capsules had U.S. sales of approximately $2.5B for the 12 months ending September 30, 2014.
December 9, 2014
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.”
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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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.
08:03 EDTPFEPfizer announces agreement with Spark Therapeutics to develop SPK-FIX
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