Zogenix (NASDAQ:ZGNX) is on the wrong side of the headlines today as the drugmaker received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) in relation to its latest seizure drug.
The Emeryville, Calif.-based global pharmaceutical business announced that the letter was sent in regards to its New Drug Application (NDA) for Fintepla, which is a moniker for ZX008, fenfluramine hydrochloride. The company, which is dedicated to developer therapies for rare diseases, is hoping Fintepla will help treat seizures linked with Dravet syndrome.
The illness is a rare form of epilepsy that begins in infancy and affects roughly 1 in 18,500 people. The FDA sent Zogenix the RTF as it determined the NDA, which was submitted on February 5, 2019, did not have all the necessary information to allow for a substantive review.
The agency said in its letters that it had two reasons for the RTF call, including that certain non-clinical studies were not submitted to allow for the assessment of the chronic administration of fenfluramine. The other reason was that the application included an incorrect version of a clinical dataset, preventing the completion of the review process necessary to support the filing of the NDA.
The FDA has not requested or recommended any additional clinical efficacy or safety studies from Zogenix. The pharmaceutical business said it will seek immediate guidance, which includes a meeting with the FDA to clarify and address the issues included in the RTF letter.
ZGNX stock fell about 0.3% during regular trading hours, then plummeted about 31.6% after the bell following the news.
