AB Science Plunges After Regulator Suspends French Drug Trials
- EU unlikely to recommend drug approval this week, Kepler says
- Company has corrected clinical trial flaws, CEO Moussy says
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AB Science SA shares plunged the most on record after France’s drug agency ordered the biotechnology company to suspend clinical trials in the country because of flaws in previous studies, making it unlikely the company will win regulatory backing this week for its lead medicine.
The decision by the National Agency for Drug Safety, known as ANSM, resulted from a series of inspections from 2006 to 2016 that showed “repeated and serious violations” of laws and regulations, some of which could have put patients’ safety at risk, the regulator said in a May 11 statement. Paris-based AB Science failed to continuously evaluate the safety of masitinib and to properly manage its database of side effects, the agency said.