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April 2, 2014
11:55 EDTQURE, BAX, PFE, SGMO, BMRN, NVO, BIIBUniqure rises after Baxter acquires Chatham Therapeutics
U.S.-listed shares of Netherlands-based pharmaceutical company Uniqure (QURE) are rising after Baxter International (BAX) acquired Chatham Therapeutics, which is developing gene therapy treatments intended for patients with hemophilia. WHAT'S NEW: Baxter agreed to acquire all of Chatham’s outstanding membership interests and as a result will acquire Chatham’s developmental gene therapy programs directed toward the development and commercialization of treatments for hemophilia. Under the terms of the agreement, Baxter will make an initial payment of $70M to acquire all of the outstanding membership interests of Chatham and may make additional payments in the future. Baxter will continue the ongoing Phase I/II open-label clinical trial to assess the safety and optimal dosing schedule of hemophilia treatment BAX 335. ANALYST REACTION: Research firm Piper Jaffray said the Baxter acquisition has a positive read-through for Uniqure. The deal validates other hemophilia gene therapy programs in development, most notably Uniqure's, according to the firm. Analyst Joshua Schimmer wrote that there are other gene therapy programs for hemophilia in development beside Uniqure's and Baxter's, but he believes Uniqure has an advantage since it will be important to be among the first to market. The analyst also said that the market is large enough to accommodate more than one gene therapy option. Piper reiterated its Overweight rating and $35 price target on Uniqure. OTHERS TO WATCH: Other companies noted by Piper as currently offering hemophilia treatments or working on hemophilia therapies include Pfizer (PFE), Novo Nordisk (NVO), Biogen (BIIB), Sangamo (SGMO) and BioMarin (BMRN). PRICE ACTION: During late morning trading, shares of Uniqure rose 77c or 4.92% to $16.43, while Baxter slid 33c, or 0.45%, to $73.34.
News For QURE;BAX;PFE;SGMO;BMRN;NVO;BIIB From The Last 14 Days
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August 26, 2014
18:20 EDTBMRNOn The Fly: After Hours Movers
UP AFTER EARNINGS: TubeMogul (TUBE), up 31.8% after reporting better than expected second quarter results and guidance above analyst estimates... Aruba Networks (ARUN), up 2.3% after reporting quarterly results and announcing a 3.7% workforce reduction... HEICO (HEI), up 2.3% after raising fiscal 2014 net income guidance. ALSO HIGHER: Chemtura (CHMT) and Diebold (DBD) are both up marginally after Mario Gabelli commented on the companies in an interview with CNBC. DOWN AFTER EARNINGS: Smith & Wesson (SWHC), down 10.2% after reporting disappointing first quarter results and lowering fiscal 2014 outlook. ALSO LOWER: Sturm, Ruger (RGR), down 4% after Smith & Wesson reported quarterly results... BioMarin (BMRN), down 1.35 after lowering fiscal 2014 revenue guidance.
16:36 EDTBMRNBioMarin lowers FY14 revenue view to $680M-$700M from $745M-$765M
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11:21 EDTBIIBBiogen added to short term buy list at Deutsche Bank
10:18 EDTNVONovo Nordisk has no plans for large acquisitions, WSJ says
Lars Sorensen, the CEO of Denmark-based Novo Nordisk, says that despite the increased deal-making activity in the global pharmaceutical industry of late, Novo Nordisk has no plans to acquire any entity that it can't fund through its own cash flows, says the Wall Street Journal. Reference Link
08:01 EDTPFEPfizer, Merck to collaborate on study evaluating anti-cancer combination regimen
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August 25, 2014
06:29 EDTPFEPfizer mulls possible AstraZeneca offer options, FT says
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August 22, 2014
14:19 EDTPFEViiV Healthcare receives FDA approval for HIV-1 treatment Triumeq
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12:39 EDTBIIBThese five companies will benefit from increased ALS awareness, MarketWatch says
A recent surge in funding for Lou Gehrig's disease, or ALS, caused by the Ice Bucket challenge that is widespread on social media outlets, will benefit five pharmaceutical companies that are involved in the development of a cure for ALS, according to MarketWatch. The companies that are or have been involved in developing a treatment for ALS include Biogen Idec (BIIB), Avanir Pharmaceuticals (AVNR), Isis Pharmaceuticals (ISIS), Sanofi (SNY), and Bristol-Myers Squibb (BMY), MarketWatch added. Reference Link
August 21, 2014
15:37 EDTBAXNektar: Baxter announces positive results from Phase 3 study of BAX 855
Nektar Therapeutics (NKTR) reports Baxter International (BAX) announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII treatment for hemophilia A based on ADVATE, which met its primary endpoint in reducing annualized bleed rates in the prophylaxis arm compared to the on-demand arm. Top-line results from the prospective, global, multi-center Phase 3 study demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding, routine prophylaxis and perioperative management for patients who were 12 years or older. Patients in a twice-weekly prophylaxis arm experienced a 95 percent reduction in median ABR as compared to those in the on-demand arm (1.9 vs. 41.5, respectively). BAX 855 was also effective in treating bleeding episodes, 96 percent of which were controlled with one or two infusions. The half-life of BAX 855 was 1.4 - 1.5 times that of ADVATE, consistent with the findings from the Phase 1 study. No patients developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity, were reported. The most common product-related adverse event was headache. Baxter expects to submit a Biologics License Application for BAX 855 to the U.S. Food and Drug Administration before the end of 2014 and will present additional data in the coming months. In addition to an ongoing continuation study for patients who have completed the pivotal trial, the company is initiating a Phase 3, prospective, open-label, multi-center study to evaluate the safety and efficacy of BAX 855 among 60 previously treated patients under the age of 12 with severe hemophilia A. Consistent with guidelines published by the European Medicines Agency that require a study in children less than 12 years of age prior to filing, Baxter expects to file a Marketing Authorization Application with the EMA upon the completion of the pediatric study
13:32 EDTPFEBristol-Myers, Pfizer announce approval of Eliquis for treatment of DVT, PE
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09:54 EDTPFEPotential Pfizer, AstraZeneca deal seen around year-end, Reuters says
Investors and analysts see Pfizer (PFE) making another attempt to acquire AstraZeneca (AZN) around year-end, even though talks between the two can resume on August 26 per British takeover rules, Reuters reports. Reference Link
09:02 EDTBAXBaxter announces BAX 855 met primary endpoint in Phase 3 study
Baxter announced "positive" results from its Phase 3 pivotal clinical trial of BAX 855, which met its primary endpoint in reducing annualized bleed rates in the prophylaxis arm compared to the on-demand arm. Top-line results from the prospective, global, multi-center Phase 3 study demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding, routine prophylaxis and perioperative management for patients who were 12 years or older. Patients in a twice-weekly prophylaxis arm experienced a 95% reduction in median ABR as compared to those in the on-demand arm. BAX 855 was also effective in treating bleeding episodes, 96% of which were controlled with one or two infusions. The half-life of BAX 855 was 1.4 – 1.5 times that of ADVATE, consistent with the findings from the Phase 1 study. No patients developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity, were reported. The most common product-related adverse event was headache. Baxter expects to submit a Biologics License Application for BAX 855 to the U.S. Food and Drug Administration before the end of 2014 and will present additional data in the coming months. In addition to an ongoing continuation study for patients who have completed the pivotal trial, the company is initiating a Phase 3, prospective, open-label, multi-center study to evaluate the safety and efficacy of BAX 855 among 60 previously treated patients under the age of 12 with severe hemophilia A. Consistent with guidelines published by the European Medicines Agency that require a study in children less than 12 years of age prior to filing, Baxter expects to file a Marketing Authorization Application with the EMA upon the completion of the pediatric study.
08:02 EDTPFEPfizer initiates U.S. EAP for palbociclib.
Pfizer announced that the company has initiated a multi-center, open-label expanded access program in the U.S. for palbociclib. Through the program, palbociclib is being made available for use in combination with letrozole for post-menopausal women with hormone receptor positive human epidermal growth factor receptor 2 negative advanced breast cancer for whom letrozole is considered appropriate therapy.
07:55 EDTPFEActavis volatility expected to move on Pfizer considering new target report
Actavis (ACT) volatility is expected to move on Pfizer (PFE) considering other overseas alternatives, Bloomberg reports. Overall option implied volatility of 27 is near its 26-week average of 31 according to Track Data, suggesting decreasing price movement.
07:47 EDTPFEPfizer looking at new targets, including Actavis, Bloomberg reports
While it weighs another attempt to acquire AstraZeneca (AZN), Pfizer is considering other overseas alternatives, including Actavis (ACT), Bloomberg reports, citing people familiar with the matter. Pfizer prefers to reach a deal with AstraZeneca, and a move on another company is unlikely "anytime soon," Bloomberg adds, citing its sources. Shares of Actavis are rising 3%, or $6.65, to $230.01 in pre-market trading, while AstraZeneca is up 2% to $72.59. Reference Link
August 20, 2014
08:03 EDTPFEBristol-Myers Pfizer to present new Eliquis data
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August 19, 2014
16:33 EDTBAXBaxter to expand Alabama facility to increase dialyzers production
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August 18, 2014
11:41 EDTPFECubist rises after report sparks takeover interest speculation
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08:01 EDTPFEPfizer announces submission of Palbociclib NDA to FDA
Pfizer announced it has completed the submission of a New Drug Application to the United States Food and Drug Administration for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive, human epidermal growth factor receptor 2 negative advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients. Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Pfizer will communicate the Agency’s decision.
07:57 EDTPFECambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
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