AB Science is resuming stock trading after a request to suspend clinical trials in France hit the company hard last week.
After a request from the Agence Nationale de la Sécurité des Médicaments (ANSM) last week to temporarily suspend all ongoing masitinib studies in France, AB Science stopped all stock trading to avoid the oncoming disaster. The French analyst Oddo has massively slashed its price target from €48 to €5, while others have suspended all coverage of the company. Trading was back on at 9 AM today, and in less than two hours, the stock is already down by 32%.
The ANSM request came following an EMA inspection for the marketing authorization process of the drug masitinib to treat mastocytosis, a rare disorder of the skin caused by the accumulation of mast cells. The inspection encountered deviations from established good clinical practice (GCP) and pharmacovigilance during a pivotal trial with masitinib in mastocytosis.
Given that AB Science is mostly built around a single compound for multiple indications, the entire clinical pipeline has been halted in France. In other locations, where inspections have not revealed any issues, the studies are still ongoing.
AB Science’s explanation is that the study in question, AB06006, a Phase III trial which evaluated masitinib as a treatment for mastocytosis, was conducted between 2009 and 2015. Therefore, the study does not reflect the company’s newest quality system, put in practice in mid-2015.
Now, AB Science has been asked to confirm the quality of key efficacy data and adverse events in mastocytosis and amyotrophic lateral sclerosis (ALS) studies in an independent audit that will be performed in the coming months. The ANSM has confirmed that positive results of the audit will let the company restart clinical trials in France.
AB Science has remarked that the current issues will not affect its ALS study, since it benefited from the new quality system and was not conducted in France. Positive results of a Phase III trial in ALS were recently published, supporting a good outcome for the marketing authorization application that AB Science filed with the EMA last September. The results of the upcoming audit are expected before the EMA conducts inspections regarding the marketing authorization.
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