Zogenix, Inc. (ZGNX - Free Report) announced that the FDA has approved Fintepla (fenfluramine) oral solution, CIV for the treatment of seizures associated with DravetSyndrome in patients 2 years of age or older.
The FDA’s approval was based on data from two placebo-controlled phase III studies and safety data from an extension study. The data showed that when Fintepla was added to existing treatments, the drug significantly reduced monthly convulsive seizure frequency compared to placebo in patients whose seizures were not adequately controlled byantiepileptic drugs. Further, most study patients responded to the treatment with Fintepla within three to four weeks and the effects remained consistent over the treatment period.
Fintepla will be launched through a restricted distribution program, called the Fintepla Risk Evaluation and Mitigation Strategy (REMS) Program. The drug is expected to be available through Zogenix's specialty pharmacy partner by the end of July.
Approval of the drug will be a boost the company’s sales.
Shares of the company have slumped 46.1% year to date compared with the industry’s decline of 4.7%.
Dravet syndrome is a rare childhood-onset epilepsy, marked by frequent and severe treatment-resistant seizures as well as significant developmental and motor impairments, and an increased risk of sudden unexpected death.
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 2years of age or older.
Zacks Rank & Stocks to Consider
Zogenix currently carries a Zacks Rank #2 (Buy).
Some better-ranked stocks from the same space are Amneal Pharmaceuticals Inc. (AMRX - Free Report) and MEI PharmaInc. (MEIP - Free Report) , each carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Amneal’s earnings per share estimates have increased from 49 cents to 57 cents and from 63 cents to 67 cents for 2020 and 2021, respectively, in the past 60 days.
MEI Pharma’sloss per share estimates have narrowed from 58 cents to 14 cents for 2020 and from 53 cents to 39 centsfor 2021 over the past 60 days.
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