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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

BRIEF-AB Science: CHMP adopts negative opinion for Masitinib marketing authorization

* REG-AB SCIENCE ANNOUNCES THAT CHMP ADOPTED A NEGATIVE OPINION FOR MASITINIB MARKETING AUTHORIZATION IN INDOLENT SYSTEMIC MASTOCYTOSIS AFTER REASSESSMENT