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June 1, 2014
16:17 EDTNKTRNektar announces new data from Phase 2 study of NKTR-102
Nektar Therapeutics announced new data from an investigator-sponsored Phase 2 study of NKTR-102, etirinotecan pegol, in patients with Avastin-refractory high-grade glioma conducted at Stanford Cancer Institute under the direction of Lawrence Recht, M.D., Professor of Neurology and Neurosurgery, with co-investigator Seema Nagpal, M.D., Clinical Assistant Professor of Neurology and Neurological Sciences, Stanford School of Medicine. The primary endpoint was met and exceeded with fifty-five percent of patients in the study achieving six-week progression-free survival. Response and disease progression were assessed by RANO criteria in the trial. Three patients, or 15%, achieved partial responses with NKTR-102 monotherapy with maximum percent reductions in tumor area of 86%, 72%, and 59%. An additional eight patients, or 40%, achieved stable disease as best response. Two of the three patients with RANO responses experienced a long duration of response of 14 and 20 months. Secondary endpoints include median progression-free survival, median survival from time of first NKTR-102 infusion and median overall survival from date of pathologic diagnosis or confirmation of high-grade glioma. NKTR-102 monotherapy was well-tolerated in patients with Avastin-refractory high-grade glioma with low toxicity in spite of being heavily pre-treated and neurologically symptomatic. Only one patient had Grade 3 toxicity attributable to NKTR-102 as a result of not taking anti-diarrheal medication. Hematologic toxicity was mild. As of May 31, there is one patient in the study who is continuing on NKTR-102 monotherapy.
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September 19, 2014
09:01 EDTNKTRNektar presents preclinical data on kappa opioid receptor
Nektar announced results from preclinical studies characterizing the analgesic profiles of a series of the company's internally-discovered oral, peripherally-acting kappa opioid receptor agonist molecules. The analgesic properties of kappa receptor agonism are well described in the medical literature.1,2 Kappa opioid receptors are expressed in the peripheral nervous system as well as in the central nervous system, and activation of these receptors at both sites has been shown to result in a reduction in pain and inflammation in a wide range of preclinical models. However, the therapeutic use of kappa receptor agonists has been limited because activation of these receptors in the CNS is associated with significant dysphoria and other unwanted side effects.
September 17, 2014
08:50 EDTNKTRNektar Movantik approval positive, says Roth Capital
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September 16, 2014
14:33 EDTNKTRNektar price target raised to $20 from $18 at Brean Capital
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13:22 EDTNKTRNektar approval improves risk/reward, says Piper Jaffray
Piper Jaffray says today's FDA approval of Movantik improves the risk/reward on shares of Nektar. Piper expects Movantik to be one of a series of successes for the company and reiterates an Overweight rating on the stock with a $20 price target. The firm says the post-marketing study required by the FDA to evaluate potential cardiovascular risks was expected.
13:17 EDTNKTRNektar up 3% after FDA approves Movantik for treatment of OIC
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12:37 EDTNKTRNektar reports FDA approval of MOVANTIK for treatment of OIC
Nektar Therapeutics (NKTR) reported that partner AstraZeneca (AZN) announced that the FDA approved MOVANTIK tablets as the first once-daily oral peripherally-acting mu-opioid receptor antagonist medication for the treatment of opioid-induced constipation, or OIC, in adult patients with chronic, non-cancer pain. In line with the recommendation from the FDA Anesthetic and Analgesic Drug Products Advisory Committee that took place in June, AstraZeneca has agreed to conduct a post-marketing, observational epidemiologic cardiovascular safety study for MOVANTIK. MOVANTIK is expected to be available to patients in the first half of 2015. MOVANTIK is currently a schedule II controlled substance because it is structurally related to noroxymorphone. During the review of the New Drug Application, the FDA evaluated the abuse potential of MOVANTIK and the approved labelling indicates that MOVANTIK has no risk of abuse or dependency. AstraZeneca submitted a petition for the descheduling of MOVANTIK to the U.S. Drug Enforcement Administration, or DEA, in March 2012, which was accepted for review and will be considered by the DEA as part of the process for addressing the descheduling request.
10:19 EDTNKTRFDA approves Movantik with requirement for cardiovascular risk study
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10:11 EDTNKTRNektar trading halted, pending news
08:00 EDTNKTRFDA PDUFA Date for Nektar and AstraZeneca''s Movantik is September 16, 2014

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