Key Developments: Nektar Therapeutics (NKTR.O)
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24 May 2013
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Latest Key Developments (Source: Significant Developments)
Nektar Therapeutics Reaffirms FY 2013 Revenue Guidance-Conference Call
Nektar Therapeutics expects revenue for fiscal 2013 to be in between $200-$210 million. This guidance includes $95 million in milestone payments for the acceptance of regulatory filings for naloxegol, which breaks out as follows, $70 million for the US, and $25 million for the EU. Fiscal 2013 revenue guidance also includes $20 million of non-cash royalty revenue from UCB Cimzia and Roche's Mircera. Full Article
Nektar Therapeutics Announces Positive Preclinical Data For NKTR-214
Nektar Therapeutics announced positive preclinical data for NKTR-214, a novel cancer immunotherapy which targets the IL-2 receptor complex, at the 2013 American Association for Cancer Research (AACR) Annual Meeting. NKTR-214 is a new immunocytokine that is being developed as a potential treatment for multiple cancers. NKTR-214 targets the IL-2 receptor complex through selective receptor binding to the IL2Rβ subtype. Activation of the IL2Rβ subtype promotes tumor killing by the body's own immune system. NKTR-214 is a novel immunocytokine therapy that is engineered using Nektar's polymer conjugate technology to selectively target the beneficial IL-2 receptor complex. In the preclinical data presented at AACR, NKTR-214 exhibits differentiated IL-2 receptor binding which results in significantly altered immune cell populations in the tumor microenvironment compared to the clinically validated IL-2 protein therapy, aldesleukin. Specifically, NKTR-214 maintains high affinity for the IL-2 receptor subunit beta, which activates tumor-killing T cells within the tumor microenvironment. At the same time, NKTR-214 exhibits up to 100-fold reduced affinity to the IL-2 receptor subunit alpha-beta, which activates immuno-suppressive regulatory T-cells. In a well-validated animal model of melanoma, NKTR-214 demonstrated significantly improved dosing, at once every 9 days as compared to twice a day dosing with aldesleukin. Full Article
Nektar Therapeutics Issues FY 2013 Revenue Guidance Above Analysts' Estimates-Conference Call
Nektar Therapeutics announced that for fiscal 2013, it expects revenue to be between $200 million and $210 million. According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $175 million for fiscal 2013. Full Article
Nektar Therapeutics Reaffirms FY 2012 Revenue Guidance-Conference Call
Nektar Therapeutics announced that for fiscal 2012, it expects revenue to be between $75 million and $85 million. According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $81 million for fiscal 2012. Full Article
FDA Grants Fast Track Designation To Nektar Therapeutics's NKTR-181
Nektar Therapeutics announced that the U.S. Food and Drug Administration (FDA) has designated NKTR-181 as a Fast Track development program for the treatment of moderate to severe chronic pain. NKTR-181 is a mu-opioid agonist molecule, which is designed to have a slow rate of entry into the brain to reduce the attractiveness of the molecule as a target of abuse and to reduce its CNS-mediated side effects. NKTR-181 was created using Nektar's polymer conjugate technology and potential differentiating properties are inherent to the design of the new molecule. NKTR-181 has completed a Phase 1 clinical development program, which evaluated pharmacokinetics, pharmacodynamics and safety in more than 180 healthy subjects. The Phase 2 development program for NKTR-181 will use a standard, randomized, placebo-controlled withdrawal design to evaluate the efficacy and safety of this new opioid molecule in up to 200 patients with chronic pain from osteoarthritis of the knee. A human abuse liability study is also planned as part of NKTR-181's Phase 2 development. Under the FDA Modernization Act of 1997, the Fast Track program facilitates interactions with the FDA before and during the submission of a New Drug Application (NDA) for therapeutics being investigated as a treatment for serious or life-threatening conditions, which demonstrate the potential to address an unmet medical need for such a condition. Full Article
Nektar Therapeutics Issues FY 2012 Revenue Guidance In Line With Analysts' Estimates-Conference Call
Nektar Therapeutics announced that for fiscal 2012, it expects revenue to be between $75 million and $85 million. According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $81 million for fiscal 2012. Full Article
Nektar Therapeutics Issues FY 2012 Revenue Guidance Below Analysts' Estimates-Conference Call
Nektar Therapeutics announced that for fiscal 2012, it expects revenue to be in the range of $75-$85 million. According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $91 million for fiscal 2012. Full Article
Nektar Therapeutics Announces Agreement to Sell CIMZIA and MIRCERA Royalties to Royalty Pharma for $124 Million
Nektar Therapeutics announced that it agreed to sell to Royalty Pharma its royalties on future sales of CIMZIA, under Nektar's agreement with UCB Pharma, and MIRCERA, under Nektar's agreement with Roche. In consideration for the sale, Royalty Pharma will pay Nektar an aggregate cash payment of $124.0 million. Full Article
Nektar Therapeutics Announces Positive Clinical Data From Second Phase 1 Clinical Study Of NKTR-181
Nektar Therapeutics announced positive data from a Phase 1 clinical study of NKTR-181 evaluating multiple ascending oral doses of NKTR-181 over an 8-day treatment period in healthy subjects. NKTR-181 is Nektar's new oral opioid analgesic candidate designed to address the abuse liability and serious central nervous system (CNS) side effects associated with current opioid therapies. In this multiple dose Phase 1 study, NKTR-181 exhibited a sustained analgesic response, supporting its development as a twice-daily oral tablet for the treatment of chronic pain conditions. Pupillometry data from the study demonstrated that NKTR-181's centrally-mediated opioid effects are dose-dependent and that the molecule enters the brain slowly, which could reduce the euphoria and other CNS side effects that are associated with current opioids. NKTR-181 was also well-tolerated over the entire 8-day dosing period in the study at all doses evaluated. In the Phase 1 multiple ascending dose study, NKTR-181 produced a dose-dependent and sustained analgesic response in a model of pain used in healthy subjects to measure central analgesic activity. NKTR-181 exhibited predictable dose-linear pharmacokinetics across all dose levels with an average half-life of approximately 12 hours and no evidence of pharmacological tolerance over the 8 days of twice-daily dosing. The sustained central response, analgesic effect and safety profile over a 12-hour period supports a twice-daily dosing schedule. Full Article
Nektar Therapeutics Initiates Phase 3 BEACON Trial Of NKTR-102 In Women With Metastatic Breast Cancer
Nektar Therapeutics announces that it has initiated its pivotal Phase 3 global clinical trial evaluating NKTR-102 as a single agent in women with metastatic breast cancer. NKTR-102 is a next-generation topoisomerase I inhibitor designed using Nektar's proprietary polymer conjugate technology, and is being developed in multiple tumor settings. The BEACON Study (BrEAst Cancer Outcomes with NKTR-102) is designed to include approximately 840 metastatic breast cancer patients who have had prior treatment with anthracycline, taxane and capecitabine in either the adjuvant or metastatic setting. Full Article
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