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News Breaks
March 20, 2014
05:51 EDTAGEN, GSKGSK's MAGRIT study did not meet first or second co-primary endpoint
Agenus (AGEN) announced that GlaxoSmithKline’s (GSK) MAGRIT study, a Phase 3 randomized, blinded, placebo-controlled MAGE-A3 cancer immunotherapeutic trial in non-small cell lung cancer patients, which contains Agenus’QS-21 Stimulon adjuvant, did not meet its first or second co-primary endpoint. The study did not significantly extend the disease-free survival, or DFS, period when compared to placebo in the overall MAGE-A3 positive patients or patients who did not receive chemotherapy. GSK announced that it will continue the study until an analysis of the third co-primary endpoint is complete. The third co-primary endpoint is based on predefined criterion that was discussed with regulatory authorities. This analysis is based on gene signature and designed to prospectively identify MAGE-A3 positive patients who may benefit more from treatment. If further analysis shows that the predefined gene signature subset data are successful, there is the potential for regulatory filing. GSK anticipates that these data should be available in 2015. Until then, GSK will remain blinded to all safety and efficacy data. The Independent Data Monitoring Committee for the MAGRIT study indicated that a review of the safety information raised no specific concern for the continuation of the trial.
News For AGEN;GSK From The Last 14 Days
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April 24, 2015
07:11 EDTGSK, AGENAgenus: GSK's RTS,S vaccine showed statistically significant results in study
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April 23, 2015
07:03 EDTAGENAgenus reports Q1 EPS (28c), may not compare to consensus (1c)
Reports Q1 revenue $3.95M, may not compare to consensus $11.66M.
April 22, 2015
14:56 EDTAGENAgenus management to meet with William Blair
Meeting to be held in Philadelphia on April 27 hosted by William Blair.
April 20, 2015
07:20 EDTGSKAmerican Association for Cancer Research to hold annual meeting
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07:01 EDTGSKPernix Therapeutics obtains six months U.S. pediatric exclusivity for Treximet
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April 16, 2015
09:14 EDTGSKAdamis says albuterol HFA product study met clinical FEV1 primary endpoint
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08:15 EDTGSKGlaxoSmithKline and Theravance announce launch of Anoro in Spain
In a regulatory filing, GlaxoSmithKline (GSK) and Theravance (THRX) announced the launch of Anoro in Spain following the approval in Europe in May 2014. Anoro Ellipta is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. Anoro Ellipta is a combination of two bronchodilators, umeclidinium, a long-acting muscarinic antagonist and vilanterol, a long-acting beta2 agonist, in a single dry powder inhaler, the Ellipta. The approved dose of UMEC/VI is 55/22mcg. UMEC/VI has been developed under the 2002 LABA collaboration agreement between Glaxo Group Limited and Theravance.
April 15, 2015
11:53 EDTGSKGlaxoSmithKline initiated with a Sell at Societe Generale
07:41 EDTAGENEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.

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