AB Science announces it has filed masitinib for the treatment of ALS to the EMA based on the PII/III AB10015 trial 
AB Science announces it has received authorisation from the FDA to resume patient enrolment in the confirmatory PIII study .
AB Science announces it has received authorisation from the French National Agency for the Safety of Medicines and Health Products (ANSM) to resume patient enrollment in the confirmatory PIII study in ALS, and from Norway and other European countries .
Company suspends all ongoing masitinib trials (in mastocytosis, ALS and COVID) while they investigate a possible risk of ischaemic heart disease .
In 2020, AB Science will continue to allocate the bulk of its resources to the further development of masitinib, including initiating the confirmatory study in ALS .
AB Science expects that the COVID-19 pandemic will have limited impact on development of masitinib. However, for the new PIII AB19001 confirmatory study, patient enrolment will start once post-pandemic conditions permit proper access to the sites, which may delay the enrolment date initially planned in March 2020 by up to 3 months .
AB Science will make a decision on whether to re-file to the EMA in Q1 20, and if so a decision from the EMA would be expected by end Q4 20 .
AB Science has new data to address the three major objections previously raised by EMA. However, no decision has been taken yet regarding a potential new submission for conditional marketing authorisation based on the final results from AB10015 study. If a new submission is made, it can only be under the normal assessment timeline because results for single pivotal study need to be exceptionally compelling in the context of an accelerated assessment .
AB Science is continuing to evaluate the possibility to resubmit the application based on the final results from study AB10015. As part of the resubmission, AB Science intends to submit final safety data, new sensitivity analyses on the primary analysis of the ALSFRS-R score for patients who stopped the study prematurely, applying recommended methods as per EMA guidelines in order to corroborate the results based on the LOCF method (last observation carried forward), and new preclinical data reinforcing the mechanism of action of masitinib, which is an important consideration in the context of an application based on a single pivotal trial. Moreover, a second study is needed to confirm the results of this first pivotal study, even in case of positive opinion by the CHMP. AB Science will initiate this confirmatory study in the treatment of ALS once the scientific advice procedure regarding the design of the trial is completed and once the ANSM clinical hold is lifted .
AB Science announces it will not pursue re-examination of its European marketing application for masitinib as a treatment for amyotrophic lateral sclerosis (ALS) after all, as it has concluded that the re-examination procedure would not be the most appropriate format to address all the pending concerns raised by the CHMP, largely because new data cannot be submitted as part of the process. Instead, it intends to discuss with the EMA the pathway forward to seek marketing authorisation, including submission of final safety data from study AB10015 and new preclinical data reinforcing the mechanisms of action of the drug .
AB Science has requested re-examination of the CHMP written negative opinion: the Committee will therefore re-examine its opinion and issue a final recommendation. The Committee had originally concluded that the main study in patients with ALS did not show that the drug was effective in slowing disease progression; it considered that the patient classification used was arbitrary and that deficiencies in the way the study was performed in two sites cast doubt on the integrity of the data .
CHMP has adopted a negative opinion for the marketing authorization of masitinib in the treatment of adult patients with Amyotrophic Lateral Sclerosis. Next opinion due July 18 .
AB Science announces that the EMA has accepted the filing for masitinib in treatment of ALS, based on the results of preclinical data and pre-planned interim results of the PII/III trial (NCT02588677). The final EMA decision is expected in the second half of 2017 .
EMA grants orphan drug status for masitinib for ALS .
AB Science announces that Rapporteurs appointed by the EMA have recommended the filing of masitinib in combination with riluzole in the treatment of adult patients with ALS for conditional marketing authorisation. This request for filing was based on clinical data from the phase 2/3 study AB10015, which was successful on its pre-specified primary endpoint at the interim analysis, as well as preclinical data on masitinib mechanism of action in ALS, and manufacturing process. AB Science expects to file by end Q3 16 .
Granted orphan drug status for ALS in the US .
PIII for ALS .