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News Breaks
August 21, 2014
15:37 EDTNKTR, BAXNektar: 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
News For NKTR;BAX From The Last 14 Days
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April 1, 2015
08:13 EDTBAXBaxter completes European CE mark approval for Homechoice Claria
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March 25, 2015
07:12 EDTBAXAmerican Academy of Orthopedic Surgeons to hold annual meeting
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March 24, 2015
10:17 EDTNKTROptions with decreasing implied volatility
Options with decreasing implied volatility: FOLD NKTR GES VHC CTRP WSM WLL LNCO NLY ORCL
March 23, 2015
11:22 EDTNKTROptions with decreasing implied volatility
Options with decreasing implied volatility: FOLD NKTR RUSL XONE GES CTRP WSM NLY ADBE ORCL
March 20, 2015
10:18 EDTNKTROptions with decreasing implied volatility
Options with decreasing implied volatility: NKTR FOLD RUSL RSX ORCL GES CTRP SLXP WSM SPXS
March 19, 2015
10:42 EDTNKTROptions with decreasing implied volatility
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08:37 EDTNKTRNektar and Daiichi Sankyo to commercialize Movantik in the U.S.
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March 18, 2015
12:38 EDTNKTROn The Fly: Midday Wrap
Stocks on Wall Street were lower at midday ahead of the conclusion of the Federal Reserve's latest rate setting meeting and the central bank's accompanying announcements. The averages began the session in negative territory and have been range-bound throughout the morning. The Dow was down triple digits once again, making 8 consecutive days that the blue chip index has seen a triple digit move. ECONOMIC EVENTS: In the U.S., the DOE petroleum inventory reports showed a 9.6M barrel rise in crude stocks in the week of March 13, versus expectations for a 4.4M build. The day's big economic news is yet to come, with the Fed's FOMC meeting announcement due at 2:00 pm EDT and Fed Chair Yellen holding a press conference a half hour later. Elsewhere, Prime Minister Benjamin Netanyahu unexpectedly defeated his main challenger in Israelís election and his Likud party appears set to capture more parliament seats. COMPANY NEWS: Shares of FedEx (FDX) slid 2.5% after the shipping giant reported earnings that beat estimates, but revenue that fell short of the consensus forecast, for its third fiscal quarter. FedEx noted that it expects to deliver "record" yearly earnings for the current fiscal year and next fiscal year as well... Oracle (ORCL) shares rose 2.5% after the company's third quarter profits matched expectations and it raised its quarterly dividend 25%. MAJOR MOVERS: Among the notable gainers was Vitesse Semiconductor (VTSS), which jumped 37% after the company agreed to be acquired for $5.28 per share in cash by Microsemi (MSCC). Also higher was Retrophin (RTRX), which rose 28% after the company said it will exercise its right to purchase from Asklepion Pharmaceuticals all worldwide rights, titles, and ownership of Cholbam after the FDA approved the drug for the treatment of pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects and for patients with peroxisomal disorders. Among the noteworthy losers was Willbros Group (WG), which dropped 55% and was downgraded to Underperform at DA Davidson after announcing its earnings report will be delayed and the company is in potential non-compliance with debt covenants. Also lower following their earnings reports were Nektar Therapeutics (NKTR), which fell 15% after the company's Phase III BEACON metastatic breast cancer study missed its primary endpoint. INDEXES: Near midday, the Dow was down 105.02, or 0.59%, to 17,744.06, the Nasdaq was down 12.45, or 0.25%, to 4,924.99, and the S&P 500 was down 7.69, or 0.37%, to 2,066.59.
10:12 EDTNKTRNektar recovers off earlier low, levels to watch
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09:23 EDTNKTROn The Fly: Pre-market Movers
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08:07 EDTNKTRNektar weakness a buying opportunity, says Brean Capital
Brean Capital said it would use any weakness following Nektar's announcement of top line results for its breast cancer drug trial as a buying opportunity. The firm noted the trial missed its primary and secondary endpoints and has removed the revenue from their estimates, leading to a lowering of its price target to $17 from $20, but maintained its Buy rating on Nektar shares, citing its other opportunities.
07:02 EDTNKTRNektar price target lowered to $15 from $20 at Piper Jaffray
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06:49 EDTNKTRNektar price target lowered to $17 from $19 at JPMorgan
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