Zogenix, Inc. (ZGNX - Free Report) announced that it received a Refusal to File (RTF) letter from the FDA regarding its new drug application (NDA) for Fintepla (ZX008, fenfluramine hydrochloride) for the treatment of seizures associated with Dravet syndrome. Shares of the company plunged almost 29% in pre-market trading on Apr 9. However, shares of Zogenix have surged 42.2% in the past year compared with the industry’s growth of 16.9%.
The FDA determined that the application was not sufficiently complete to permit a substantive review. Per the agency, certain non-clinical studies were not submitted to allow assessment of the chronic administration of fenfluramine, which led to issuance of the RTF letter. Another reason behind the RTF letter, as cited by the FDA, was that the application contained an incorrect version of a clinical dataset, which prevented completion of the review process that is 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 company said that it will seek immediate guidance, which includes a meeting with the FDA to clarify and address the issues included in the RTF letter.
Zogenix’s Marketing Authorization Application (MAA) for Fintepla for the treatment of seizures associated with Dravet syndrome was previously accepted for review by the European Medicines Agency (EMA). The company expects EMA to reach a decision by the first quarter of 2020.
We remind investors that GW Pharmaceuticals PLC’s (GWPH - Free Report) Epidiolex oral solution was approved by the FDA in 2018 for the treatment of Dravet syndrome in patients two years of age or older.
Zacks Rank & Stocks to Consider
Zogenix currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the same space are Eisai Co (ESALY - Free Report) and BioSpecifics Technologies Corp. (BSTC - Free Report) , each carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Eisai’s earnings per share estimates have increased from $1.86 to $1.95 and from $1.89 to $2.02 for 2019 and 2020, respectively, in the past 60 days.
BioSpecifics Technologies’ earnings per share estimates have increased from $2.78 to $3.01 for 2019 over the past 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters at an average of 12.46%.
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