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News Breaks
August 21, 2014
15:37 EDTBAX, NKTRNektar: 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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March 4, 2015
09:01 EDTBAXBaxter acquires SuppreMol for approximately $225M
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March 2, 2015
07:42 EDTBAXBaxter still undervalued heading into split, says Leerink
Leerink its sum-of-the-parts analysis indicates Baxter shares remain undervalued heading into the company's split. The firm reiterates an Outperform rating on the name with a slightly reduced price target of $82.
February 25, 2015
13:08 EDTNKTRNektar volatility increases on start of Phase 3 study of NKTR-181
Nektar March call option implied volatility is at 87, April is at 78, May is at 74; compared to its 26-week average of 70 according to Track Data, suggesting large near term price movement on the announcement of the start of Phase 3 study of NKTR-181.
09:28 EDTNKTRNektar announces start of Phase 3 study of NKTR-181
Nektar announced the enrollment of the first patient in SUMMIT-07, its initial Phase 3 study of NKTR-181, a first-in-class, opioid analgesic molecule with a slow rate of entry into the brain. The company said this slow rate of entry is designed to reduce the euphoria that can lead to the abuse of current opioid analgesics. SUMMIT-07 will evaluate the efficacy, safety and tolerability of NKTR-181 in patients with chronic low back pain who are also opioid-na´ve. NKTR-181 is a new chemical entity that was created using Nektar's proprietary small molecule polymer conjugate technology. NKTR-181 has several potential differentiating properties that are inherent to the structure of the molecule, including a slow rate of entry into the CNS as measured by pupillometry and a plasma pharmacokinetic profile that supports twice-daily oral dosing. NKTR-181 is not a reformulation of a marketed opioid, which is a commonly-used method to attempt to prevent the manipulation of existing long-acting opioid drugs into more abusable forms. NKTR-181 has been granted has been granted Fast Track designation for the treatment of moderate to severe chronic pain by the U.S. Food and Drug Administration.
February 24, 2015
17:00 EDTNKTRNektar reports Q4 EPS (35c), consensus (36c)
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February 23, 2015
09:08 EDTBAXBaxter announces Illinois headquarters for biopharmaceutical spin-off
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February 20, 2015
07:08 EDTBAXAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
February 19, 2015
18:25 EDTBAXPiper Jaffray biotech analyst to hold analyst/industry conference call
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