Zogenix, Inc (ZGNX) has announced that the U.S. Food and Drug Administration (FDA) has finally approved Fintepla (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.
The drug will now be launched through a restricted distribution program, and is expected to be available through Zogenix’s specialty pharmacy partner by the end of July.
“The approval of Fintepla by the FDA is a significant milestone” cheered Stephen Farr, CEO of Zogenix. “We began this global development program nearly six years ago after researchers in Belgium recognized the potential of fenfluramine, a drug with distinct pharmacology from all other anticonvulsant agents, to treat intractable seizures in Dravet syndrome.”
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.
“There remains a huge unmet need for the many Dravet syndrome patients who continue to experience frequent severe seizures even while taking one or more of the currently available anti-seizure medications,” said Joseph Sullivan, the Principal Investigator for Fintepla in Dravet syndrome.
The FDA’s approval was based on data from two placebo-controlled Phase 3 clinical trials, and safety data from an extension trial. When added to existing treatments, the drug significantly reduced monthly convulsive seizure frequency compared to placebo in patients whose seizures were not adequately controlled on antiepileptic drugs. In addition, most patients responded to treatment within three to four weeks and effects remained consistent.
Following the news, LifeSi Capital analyst David Sherman reiterated his buy rating on Zogenix, writing “We see this as an important cloud lifting on the stock, and think that going forward, the company may start to get their due for several of the other promising opportunities that they’re pursuing and the recent progress that they’ve made.”
Sherman added that he is waiting for more details on today’s call before updating his current price target of $45.
Likewise Mizuho Securities’ Difei Yang also reiterated her bullish perspective on the stock saying “We note that this is a broader patient designation than the Phase 3 trial, which consisted of subjects age 2-18.” The analyst points out that the labeling includes a boxed warning which states that Fintepla is associated with valvular heart disease (VHD) and pulmonary arterial hypertension (PAH)- but says that this is also ‘as expected’.
Yang already had a 100% probability of success on the indication and so reaffirmed her buy rating and $64 price target. This suggests shares can more than double from current levels.
Overall the Street has a bullish Strong Buy consensus on Zogenix, with an average analyst price target of $51 (81% upside potential). Shares are currently trading down 46% year-to-date. (See ZGNX stock analysis on TipRanks).
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