Sarepta slips further after it says it will keep selling gene therapy despite FDA’s request to pull it
Sarepta Therapeutics slipped about 5% on Monday after the drugmaker said it would continue selling its gene treatment despite a request from the US Food and Drug Administration to pull the therapy from the market.
Sarepta described the FDA’s request as “informal” in a statement that came after market close on Friday. The FDA’s request came after Sarepta disclosed last month that a second patient receiving its experimental gene therapy died of liver failure.
“Based on our comprehensive scientific interpretation of the data, which shows no new or changed safety signals in the ambulant patient population, we will continue to ship ELEVIDYS to the ambulant population,” the company said in a statement.
The drug, Elevidys, accounts for about half of Sarepta’s revenue. Including today’s decline, the stock has fallen about 40% since July 17.