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Latest Key Developments (Source: Significant Developments)

AB Science says conditional approval of Kinavet has ended in the United States
Tuesday, 15 Dec 2015 02:36pm EST 

AB Science SA:Says the conditional approval of Kinavet has ended in the United States, pending the time to obtain full approval.Marketing of Kinavet will cease in the United States, pending full approval.In the United States, the end of conditional approval will have no impact on AB Science`s P&L in 2016 since sales are at break-even point.  Full Article

AB Science completes patient enrolment for phase 3 masitinib study in ALS
Tuesday, 8 Dec 2015 01:10pm EST 

AB Science SA:Announces completion of patient recruitment for phase 3 study of masitinib in amyotrophic lateral sclerosis (ALS).Interim analysis is planned for Q1 2016.Study objective is to compare efficacy and safety of masitinib plus riluzole with placebo plus riluzole.  Full Article

AB Science announces results from Phase 3 trial on masitinib
Sunday, 6 Dec 2015 03:00pm EST 

AB Science SA:Reported results from Phase 3 randomized placebo-controlled trial of masitinib in adults with severe systemic mastocytosis unresponsive to optimal symptomatic treatment.The results showed that masitinib 6 mg/kg/day was superior to optimal symptomatic treatment on the primary efficacy analysis as well as secondary efficacy analyses.No new safety signals for masitinib were observed in this phase 3 study.Success in the primary analysis was supported by positive outcomes in all secondary analyses.  Full Article

AB Science announces publication of a significant response case with Masitinib
Wednesday, 2 Dec 2015 12:53pm EST 

AB Science SA:Announces publication of a significant response case with Masitinib in a patient with C-Kit-mutated metastatic melanoma.On-Going phase 3 with masitinib in C-Kit-mutated metastatic melanoma will have interim analysis in 2017.  Full Article

Ab Science announces positive Phase 3 results from Masitinib study
Monday, 30 Nov 2015 12:15pm EST 

AB Science SA:Announces positive top-line results from phase 3 trial of Masitinib in adults with severe systemic mastocytosis.  Full Article

AB Science says unblinding of phase 3 mastocytosis study data planned for November
Tuesday, 6 Oct 2015 12:28pm EDT 

AB Science SA:Unblinding of phase 3 mastocytosis study data planned for Nov. 2015.Based on pooled data taken from two phase 2 studies in mastocytosis, results are indicative of outcome expected for on-going phase 3 study.Announced communication of new phase 2 data in systemic severe mastocytosis aimed at simulating targeted phase 3 study population and response criteria.Near to complete first phase 3 clinical trial ever in mastocytosis.  Full Article

AB Science announces cessation of its rheumatoid arthritis study
Monday, 21 Sep 2015 12:00pm EDT 

AB Science SA:Announces cessation of its rheumatoid arthritis study in order to focus on clinical studies with a probability of success greater than 50 percent.  Full Article

AB Science SA's Masitinib receives Orphan Drug Designation for Stomach Cancer from FDA
Wednesday, 16 Sep 2015 12:08pm EDT 

AB Science SA:Says FDA has granted the company Orphan Drug designation for masitinib in the treatment of esophagogastric adenocarcinoma.Says launched a confirmatory phase 3 trial evaluating masitinib at 6 mg/kg/day in combination with irinotecan in second-line.Says study's primary endpoint is overall survival.  Full Article

AB Science announces successful non futility test for masitinib in progressive forms of multiple sclerosis
Thursday, 23 Jul 2015 01:45pm EDT 

AB Science SA:Announces successful non futility test for masitinib in progressive forms of multiple sclerosis.Independent data safety monitoring committee recommends continuation of phase 3 study based on review of safety and efficacy data.  Full Article

AB Science receives recommendation to continue phase III for masitinib in c-Kit mutated metastatic melanoma
Tuesday, 21 Jul 2015 12:30pm EDT 

AB Science SA:Announces successful futility test for masitinib in c-Kit mutated metastatic melanoma.Independent data safety monitoring committee recommends continuation of phase 3 study.Study plans to enroll 120 patients.  Full Article

BRIEF-Ab Science announces update on masitinib

* Announces the filing of masitinib in the treatment of amyotrophic lateral sclerosis (ALS) to the European medicines agency