Zogenix (NASDAQ:ZGNX) is up 22% premarket on increased volume in response to its announcement that it expects to resubmit its U.S. marketing application next month for FINTEPLA (fenfluramine) for the treatment of seizures associated with a severe type of epilepsy called Dravet syndrome.
In April, the FDA issued a Refusal to File letter to the company citing the need for certain nonclinical studies to enable the assessment of chronic administration of fenfluramine and the correct clinical dataset.
The agency agreed to its plan to refile the application without new chronic toxicity studies. The correct dataset will, of course, be included.
It has rescinded Breakthrough Therapy status since there are now two approved therapies in the U.S. for the indication.
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