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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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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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