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nektar therapeutics (NKTR) Key Developments

Nektar Therapeutics Announces Encouraging Results from Breast Tumor Preclinical Study

Nektar Therapeutics has announced results from a study investigating the preclinical anti-tumor activity and tolerability of etirinotecan pegol, or NKTR-102, in combination with the PARP inhibitor rucaparib in a BRCA1-deficient MX-1 breast tumor model. The preclinical study results demonstrated that all dose combinations of NKTR-102 and rucaparib were well-tolerated, synergistic, and led to 100% prolonged survival in this tumor model. Study investigators initiated tumor xenografts with MX-1 human breast carcinomas maintained by serial subcutaneous transplantation in female athymic nude, 8-week-old mice. On the day of tumor implant, each test mouse received a 1-mm3 MX-1 fragment implanted subcutaneously in the right flank. Animals were randomized into treatment groups when their tumors reached 63-196 mm3 and subsequently received either vehicle, NKTR-102, rucaparab, or combinations of NKTR-102 + rucaparib. Doses selected were known to provide clinically relevant exposure levels. Efficacy was measured by tumor growth delay and regression response rate. NKTR-102 and rucaparib in combination exhibited marked synergy, demonstrated by durable complete responses, even at the lowest doses of both agents dosed in combination. The combination of NKTR-102 and rucaparib was tolerated at all dose levels. Doses used in this study provide exposures of NKTR-102 and rucaparib that are achievable clinically, underscoring the translational relevance of these results. Combination studies of NKTR-102 and rucaparib are ongoing in patient-derived xenograft models in collaboration with Professor Paul Haluska at Mayo Clinic and Clovis Oncology. NKTR-102 is currently being evaluated in a Phase III, open-label, randomized, multicenter study called the BEACON study. BEACON enrolled 852 women with locally recurrent or metastatic breast cancer, who have previously been treated with anthracycline, taxane or capecitabine, and is being conducted at approximately 150 sites worldwide including North America, Western Europe, Russia and the Republic of Korea. Nearly half of the patients enrolled in BEACON were located in North America. Patients were randomized on a 1:1 basis to receive 145 mg/m2 of single-agent NKTR-102 once every three weeks or a single agent of physician's choice. The physician's choice agents include: ixabepilone, vinorelbine, gemcitabine, eribulin, or a taxane. Randomization was stratified by geographic region, prior use of eribulin and receptor status. The primary endpoint of the BEACON study is overall survival; secondary endpoints include progression-free survival, objective tumor response rates, clinical benefit rate, duration of response, pharmacokinetics, safety, quality-of-life measurements, and pharmacoeconomic implications. The study is also evaluating specific biomarker data to assess correlation with objective tumor response rates, progression-free survival, overall survival and selected toxicities.

Nektar Therapeutics Presents Preclinical Study Findings for Etirinotecan Pegol (NKTR-102) in Combination with PARP Inhibitor in BRCA1-Deficient Cancer Model

Nektar Therapeutics announced results of a study investigating the preclinical anti-tumor activity and tolerability of etirinotecan pegol (NKTR-102) in combination with the PARP inhibitor rucaparib in a BRCA1-deficient MX-1 breast tumor model. The preclinical study results demonstrated that all dose combinations of NKTR-102 and rucaparib were well-tolerated, synergistic, and led to 100% prolonged survival in this tumor model. These data were presented during the Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain, sponsored by the European Organisation for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR). NKTR-102 is the first long-acting topoisomerase I inhibitor with an extended half-life and a unique structure that is also designed to concentrate the drug in tumors. In patients, NKTR-102 leads to greatly prolonged plasma SN38 exposure compared to irinotecan (elimination half-life of 50 days compared to 2 days) yet peak SN38 concentrations are at least 5- to 10-times less, which may also result in a favorable tolerability profile. Study investigators initiated tumor xenografts with MX-1 human breast carcinomas maintained by serial subcutaneous transplantation in female athymic nude (Crl:NU(Ncr)-Foxn1nu), 8-week-old mice. On the day of tumor implant, each test mouse received a 1-mm(3) MX-1 fragment implanted subcutaneously in the right flank. Animals were randomized into treatment groups (n=10/grp) when their tumors reached 63-196 mm(3) and subsequently received either vehicle, NKTR-102, rucaparab, or combinations of NKTR-102 + rucaparib. Doses selected were known to provide clinically relevant exposure levels. Twice weekly, animals were weighed, and tumor volumes were measured until the endpoint (2,000 mm(3) or Day 88) was met. Efficacy was measured by tumor growth delay and regression response rate. NKTR-102 and rucaparib in combination exhibited marked synergy, demonstrated by durable complete responses, even at the lowest doses of both agents dosed in combination. The combination of NKTR-102 and rucaparib was tolerated at all dose levels. Doses used in this study provide exposures of NKTR-102 (SN38 trough) and rucaparib that are achievable clinically, underscoring the translational relevance of these Combination studies of NKTR-102 and rucaparib are ongoing in patient-derived xenograft models in collaboration with Professor Paul Haluska at Mayo Clinic and Clovis Oncology.

Nektar Therapeutics Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014

Nektar Therapeutics reported unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2014. For the quarter, the company reported total revenue of $132,871,000 against $60,909,000 a year ago. Income from operations was $80,321,000 against loss from operations of $6,525,000 a year ago. Income before provision for income taxes was $70,853,000 against loss before provision for income taxes of $16,350,000 a year ago. Net income was $70,605,000 against net loss of $16,543,000 a year ago. Diluted net earnings per share were $0.53 against basic and diluted loss per share of $0.14 a year ago. For the nine months, the company reported total revenue of $181,155,000 against $117,775,000 a year ago. Income from operations was $21,003,000 against loss from operations of $84,236,000 a year ago. Loss before provision for income taxes was $7,599,000 against $113,744,000 a year ago. Net loss was $8,233,000 against $114,354,000 a year ago. Basic and diluted net loss per share was $0.07 against $0.99 a year ago. Net cash used in operating activities was $117,379,000 against $92,158,000 a year ago. Purchases of property and equipment were $6,090,000 against $1,382,000 a year ago. Revenue increased in the third quarter and first nine months of 2014 as compared to the same periods in 2013 primarily due to $105.0 million in milestones recognized in September 2014 upon the approval of MOVANTIK in the U.S., of which $70.0 million was received in November 2013. These increases in revenue in 2014 were partially offset by a $25.0 million milestone payment recognized in September 2013 upon the acceptance of the MOVANTIK EMA regulatory application.

Nektar Therapeutics to Report Q3, 2014 Results on Nov 06, 2014

Nektar Therapeutics announced that they will report Q3, 2014 results at 5:00 PM, US Eastern Standard Time on Nov 06, 2014

Nektar Therapeutics, Q3 2014 Earnings Call, Nov 06, 2014

Nektar Therapeutics, Q3 2014 Earnings Call, Nov 06, 2014

 

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